Clinical Trials Conducted at Our ACTU but Have Enrolled Sufficient Volunteers. HIV Negative | Antiretroviral Naive | On Stable Therapy | Resistant to Therapy | Side Effects/Metabolic Complications| Desire to Stop Medicines | Hepatitis | Opportunistic Infections  Immunology | Neurological Complications  | Studies for Women HIV Negative Volunteers WU 178: (closed April 2006) A multicenter, open-label phase I/II study to evaluate safety and immunogenecity of MVA-BN® Smallpox Vaccine In HIV Infected persons (CD4 Counts >350 / µl) and Health persons with and without previous smallpox vaccination: Bavarian Nordic POX-MVA-010 Purpose: Because of the recent concern of biowarfare and bioterrorism throughout the world, the United States government is making efforts to improve its ability to protect its citizens in the event of a bioterrorist attack with the possible use of the smallpox virus (Variola major virus). The approved smallpox (vaccinia) vaccine Dryvax® is contraindicated for immune compromised persons such as those with HIV infection due to potential severe side effects, therefore, there is a medical need for a safer vaccine for this population. This study will compare the safety and tolerability of a new investigational smallpox vaccine called MVA-BN® in HIV infected persons to healthy (HIV) negative persons. In addition, the induction of an immune response against smallpox in persons with HIV infection will be compared to healthy HIV negative persons. MVA-BN® is a live virus vaccinia vaccine, but unlike Dryvax®, the vaccine traditionally used for smallpox vaccination, this virus has been weakened and is not able to reproduce in humans. The vaccine causes the body to have an immune response without causing a vaccination sore or scar. Drug(s) Provided by the Study: vaccines will be provided; compensation is provided A5043: closed to enrollment Apirl 2003 Pharmacokinetic Interaction Studies of Amprenavir (APV), Efavirenz (EFZ), and a Second Protease Inhibitor in HIV Seronegative Volunteers   Brief Summary: An open-label, pharmacokinetic (PK) trial of orally administered amprenavir (APV) alone, followed by APV plus efavirenz (EFV), which are then continued with or without the administration of a second protease inhibitor (PI). The second PI will be nelfinavir (NFV), indinavir (IDV), ritonavir soft gelatin capsules (RTV[sfc]), or saquinavir soft gelatin capsules (SQV[sgc]). There will be a total of five arms. Purpose: To compare the PK of APV when taken under six conditions: (1) alone, (2) with EFV, (3) with EFV plus NFV, (4) with EFV plus IDV, (5) with EFV plus RTV(sgc), and (6) with EFV plus SQV(sgc). Also, to compare the PK of EFV when taken under five conditions: (1) with APV, (2)with APV plus NFV, (3) with APV plus IDV, (4) with APV plus RTV(sgc), and (5) with APV plus SQV(sgc). Targeted Population: Healthy HIV-1 seronegative persons =18 and =65 years of age who meet the eligibility criteria. Treatment: Participants will receive their randomized study drug assignment (Arms A through E) at their first PK visit. Arm A: APV 600 mg q12h + EFV 600 mg q24h Arm B: APV 600 mg q12h + EFV 600 mg q24h +NFV 1250 mg q12h Arm C: APV 600 mg q12h + EFV 600 mg q24h + IDV 1200 mg q12h Arm D: APV 600 mg q12h + EFV 600 mg q24h +RTB(sgc) 100 mg q12h Arm E: APV 600 mg q12h + EFV 600 mg q24h + SQV(sgc) 1600 mg q12h Duration of Study: Approximately 28 days, with a six month follow up period.  A5159: "This study has closed to enrollment 1/22/03" Pharmacokinetic Interactions between HIV protease inhibitors and calcium channel blockers in Seronegative Volunteers . Brief Summary: This is a 34 day, phase I, open-label, multiple dose, two-arm pharmacokinetic study in healthy, HIV-seronegative individuals. This study will examine the drug interactions of calcium channel blockers diltiazem CD and amlodipine with protease inhibitors ritonavir and indinavir. Purpose: The primary objectives of this study are to determine the effects of indinavir and ritonavir (IDV/RTV) on the pharmacokinetics (PK) of diltiazem and amlodipine and to determine the effects of diltazem CD and amlodipine on the PK of IDV and RTV when IDV and RTV are coadministered. Targeted Population: Thirty-two health HIV-seronegative individuals. Treatment This study consists of two arms. Arm A: Diltiazem CD interaction with indinavir (IDV) and ritonavir (RTV). Arm B: Amlodipine interaction with IDV and RTV. Duration of Study: 34 days. Other Information: There are funds available for reimbursement to participating individuals. Back to top Naive to Medications A5202: (closed Jan 2008) A Phase IIIB, Randomized, Trial of Open-Label Efavirenz or Atazanavir with Ritonavir in Combination with Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naïve Subjects Brief Description:  As novel agents become available it is critical to assess their role in optimizing the management of HIV-1. This includes understanding the relative potency, tolerability, resistance patterns that emerge, and the consequent remaining treatment options if drug resistance occurs for newer regimens. This study will compare the use of RTV-enhanced ATV to EFV, in combination with either daily FTC/TDF or ABC/3TC, and of ABC/3TC compared to FTC/TDF in combination with either EFV or RTV-enhanced ATV as initial therapy for HIV-1 infection. This  is a phase IIIB, randomized, four-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced atazanavir (ATV) to efavirenz (EFV), in combination with either daily emtricitabine (FTC)/tenofovir (TDF) or abacavir (ABC)/lamivudine (3TC) and of blinded ABC/3TC compared to FTC/TDF in combination with either RTV-enhanced ATV or EFV as initial therapy for HIV-1 infection. Requirements to Enter Study: HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. Antiretroviral naïve (defined as 7 days of antiretroviral treatment prior to entry). The only exceptions are: • Use of antivirals as part of post-exposure prophylaxis (PEP) provided the subject did not acquire HIV-1 infection from the event that required PEP. • Therapy with an investigational ARV drug that was not an NRTI, NNRTI, or PI. Screening HIV-1 RNA >1000 copies/mL obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent. Laboratory values obtained within 30 days prior to study entry. • Absolute neutrophil count (ANC) 500/mm3. • Hemoglobin 8.0 g/dL. • Platelet count 40,000/mm3. • AST (SGOT), ALT (SGPT), and alkaline phosphatase 5  ULN. • Total bilirubin 2.5 x ULN. If a resistance test has been done, no evidence to NRTI, NNRTI, or PIs. Treatment: At entry participants will be randomized to one of the following with all study drugs being provided by the study: Arm A: Efavirenz (Sustiva) 600 mg once daily + FTC (Emtricitabine) 200 mg/TDF (Tenofovir) 300 mg once daily + ABC (Abacavir)/3TC (Lamivudine) placebo once daily. Arm B: Efavirenz (Sustiva) 600 mg + ABC (Abacavir) 600 mg/3TC (lamivudine) 300 mg once daily + FTC (Emtricitabine)/TDF (Tenofovir) placebo once daily. Arm C: Atazanavir (Reyataz) 300 mg once daily with Ritonavir (Norvir) 100 mg once daily + FTC (Emtricitabine) 200 mg/TDF (Tenofovir) 300 mg once daily + ABC (Abacavir)/3TC (Lamivudine) placebo once daily. Arm D: Atazanavir (Reyataz) 300 mg with Ritonavir (Norvir) 100 mg once daily +ABC (Abacavir) 600 mg/3TC (Lamivudine) 300 mg once daily + FTC (Emtricitabine)/TDF (Tenofovir) placebo once daily. In the event of treatment-limiting toxicity, within-class substitution is suggested, but not required. Duration: Individuals will participate in this study for 96 weeks beyond the enrollment of the last subject. Contact Information: Provider Summary Sheet - Word Participant Summary Sheet - Word   ACTG 5224: (closed spring 2008) Metabolic substudy of ACTG 5202 evaluating the long-term metabolic assessments in persons treated with Emtricitabine/Tenofovir or Abacavir/Lamivudine with either Efavirenz or atazanavir with Ritonavir. Individuals must be enrolled in A5202 to participate in this study. WU 208 ARIES: (closed 9/2007) Safety and Efficacy of an Initial Regimen of Atazanavir + Ritonavir + the Abacavir/Lamivudine Fixed-Dose Combination Tablet for 36 weeks followed by Simplification to Atazanavir with the Abacavir/Lamivudine Fixed-Dose Combination Tablet or Maintenance of the Initial Regimen for an Additional 48 weeks in Antiretroviral-Naïve HIV-1 Infected HLA-B*5701 Negative Subjects: EPZ108859 Purpose: To test the effectiveness (how well the drugs work) and safety of Reyataz, Norvir, and Epzicom for the treatment of human immunodeficency virus type 1 (HIV-1). Drug(s) Provided by the Study: Atazanvir, Ritonavir and Epzicom A5175:  (closed 8/07)Phase IV, Prospective, randomized, open label evaluation of the efficacy of once-daily protease inhibitor and once daily non-nucleoside reverse transcriptase inhibitor-containing therapy combinations for initial treatment of HIV-infected individuals from resource-limited settings Brief Description: This study will compare three combinations of anti-HIV drugs for the initial treatment of HIV infection. Purpose: To demonstrate the non-inferiority of a once-daily PI- and a once-daily NNRTI-containing regimen as compared with standard twice-daily ARV therapy for the initial treatment of individuals infected with HIV-1. Requirements to Enter Study: • HIV positive • CD4+ cell count less than 300. • Equal to or less than 7 days of anti-HIV drugs for HIV infection at any time prior to study entry. • Women who have taken single-dose Nevirapine or Zidovudine for any period of time during pregnancy to prevent passing on the HIV infection to the child may participate. • Men and women 18 years old or older. Treatment: STEP 1: Initial Treatment All volunteers have an equal chance of getting ONE of the following treatments: Group A: Combivir (3TC/ZDV) twice daily plus Efavirenz (EFV) once daily. Group B: Emtriva (FTC) once daily plus Atazanavir (ATV) once daily plus Videx EC (ddI- EC) once daily. Group C: Emtriva (FTC) once daily plus Tenofovir once daily plus Efavirenz (EFV) once daily. Duration of Study: At least two and a half years after the first person goes on study. The study also provides alternative drugs if you have trouble taking one of the medications and additional treatment if treatment no longer helps decrease the viral load (the amount of virus in the blood) Drug(s) Provided by the Study:  Efavirenz, FTC, Nevirapine, Tenofovir, Atazanavir, DDI, and D4T Any other medication not listed must be obtained thru a regular pharmacy Clinician Summary Sheet - WORD Participant Summary Sheet - WORD   A5164: (closed 2007) A Phase IV Study of Antiretroviral Therapy for HIV-Infected Adults Presenting with Acute Opportunistic Infections: Immediate Versus Delayed Initiation Brief Description:  This study will look at the effect of immediate treatment of HIV infection versus delayed treatment of HIV infection in people who have a serious infection.  Targeted Population: This study is for people who have developed a serious infection (an opportunistic infection or a bacterial pneumonia) due to a lowered immune system from HIV. The purpose of the study is to look at whether it is better to immediately start medicines to treat HIV while a person is being treated for the serious infection or whether it is better to delay or defer treating HIV until the serious infection has been treated. This is being done because it is not known whether the HIV medicines cause side effects that could worsen the problems for seriously ill people such as those with opportunistic infections or bacterial pneumonia. Another purpose of the study is to compare the safety and effectiveness of the HIV drugs when started during or after a serious illness. People who enter the study will be randomly assigned either to immediately start treatment for HIV (Arm A, the Immediate Treatment Group) or to wait at least 4 weeks after treating the serious infection before beginning to treat the HIV (Arm B, the Deferred Treatment Group). The study will last 48 weeks per person. Requirements to Enter the Study: ·         Age ³ 13 years. ·         Willing to give consent, or have legally authorized person give consent, to participate in this study. ·         Able to swallow medications by mouth. ·         Currently receiving treatment for an opportunistic infection or bacterial pneumonia. ·         Have not received more that 14 days of treatment for opportunistic infection or bacterial pneumonia prior to entering the study. ·         Have never taken medications to treat HIV infection or have taken such medications for a limited time only. ·         Does not have kidney failure requiring dialysis. ·         Additional requirements will be discussed by the site doctor or the study nurse.  Treatment Regimen: All patients will receive: ·                     Loprinavir/ritonavir 400 mg/100 mg by mouth, twice a day ·                     Stavudine 40 mg (or 30 mg depending on your weight) by mouth, twice a day  or an extended-release formula, Stavudine XR 100 mg (or 75 mg depending on your weight) by mouth once a day. These drugs will be provided by the study. A third or fourth drug will be selected at the discretion of the site doctor. Lamivudine is suggested as the third drug in the initial regimen but is not supplied by the study.   If assigned to Arm A (the Immediate Treatment Group), participants  will receive treatment for HIV within the first 2 weeks of starting therapy for the serious infection. If assigned to Arm B (the Deferred Treatment Group), treatment for HIV will be started at least 4 weeks after starting treatment for the serious infection. Clinician Summary - Word Participant Summary - Word A5173: (closed to enrollment 2007) A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy, Version 3.0 Purpose of this Study: Studies have shown that HIV can survive in cells for long periods of time even while a person is on HIV therapy. The HIV virus can survive in these cells for a very long time in a “resting” or “latent” state. The virus in these cells is not active but could become active in the future. The main purpose of this research study is to count the number of cells with HIV that are resting, or latent, in the blood of people taking a new combination of HIV drugs. The latent reservoir test has not been proven to be of clinical benefit. The study will look at the safety of Fuzeon (or enfuvirtide, formerly T-20) when it is given with other HIV drugs: Truvada (a combination pill with tenofovir and emtricitabine), Invirase (saquinavir), and Norvir (ritonavir). All of these drugs are approved by the FDA for treating people with HIV. Requirements to Enter Study: Plasma HIV-1 RNA greater than 1000 copies/mL obtained within 60 days prior to study entry. CD4+ cell count greater or equal to 100 cells/mm3 obtained within 60 days prior to study entry. Must have no more then seven days of previous antiretroviral therapy and no previous treatment with Fuzeon, Epivir, or Emtriva. Treatment: • Fuzeon by injection twice a day • Invirase by mouth twice a day • Norvir by mouth twice a day • Truvada by mouth once a day The study staff will teach the individual (or a person selected) how to give Fuzeon injections. The participant may choose to inject Fuzeon with a needle or a needle-free device named the Biojector 2000. Duration of Study: 96 weeks Participant Summary   WU 160: (closed October 2005) A multicenter, randomized, double-blind comparative trial of a novel CCR5 Antagoinsit, UK-427,857, in combination with Zidovudine/Lamivudine versus Efavirenz in combination with Zidovudine, Lamivudine for the treatment of antiretroviral-naive HIV-1 infected persons. Purpose: To determine the effect of UK-427,857 in comparison to Efavirenz in patients with undetectable viral load at 48 weeks. Drugs provided by the study: Combivir, Efavirenz and Pfizer entry inhibitor A5029: (closed to enrollment -  May 2003) This study will assess the prevalence and persistence of Human Papilloma Virus (HPV) DNA in HIV-infected women who will be initiating highly active antiretroviral therapy in a clinical trial or by prescription from their personal physician. Main Purposes of This Trial: 1. To compare how often DNA from HPV virus is found at the beginning of anti-HIV treatment with how often HPV DNA is found after a year of effective anti-HIV treatment. Human papilloma viruses can cause cervical cancer and/or genital warts. 2. To find out how often HPV DNA converts from positive to negative in women taking anti-HIV medications.  Requirements to Enter Study: Enrollment into an anti-HIV treatment study Signed informed consent (if under 18, parent or guardian must consent) No history of cervical cancer At least 13 years old and have started monthly menstrual periods Must be able to come to appointments as required by the study schedule Less than 14 days of anti-HIV treatment Not taking disallowed medications or vaccines (study staff will discuss with you) Medications: No extra medications required Length of Study: At least 3 years Schedule of appointments: Screening, Baseline, week 8 (blood work only), week 16, week 48, then every 48 weeks.  Pelvic examination with Pap smears will be done at most study visits To print a summary of this study just clink on either of the links below: NOTE: May 2005 One hundred forty seven (147) women living with HIV-1 infection enrolled in this study. The purpose of this study was to learn whether taking anti HIV drugs will affect the HPV virus in volunteers who had just started taking highly active antiretroviral therapy (HAART) for the first time. It also sought to determine whether volunteers would get HPV while taking anti-HIV drugs. Enough specimens have been collected  to allow for an  answer to the questions listed above. For that reason, this study is being closed.   There are no results at this time,  but we hope to have some in the near future. The results will be made public when they become available. The results may also be published in a medical journal and presented at scientific meetings A5142: (closed to enrollment May 2004) Open label  comparison of Kaletra plus Efavirenz vs Kaletra plus d4T extended release (or AZT) plus 3TC vs Efavirenz plus d4T extended release (or AZT) plus 3TC.   Description: This study will compare three combinations of medications for first treatment of HIV infection. The following treatments will be compared: 1)   Lopinavir/Ritonavir (Kaletra) + Efavirenz (Sustiva)   versus 2)   Lopinavir/Ritonavir (Kaletra) + d4T XR (Extended Release) or Zidovudine (Retrovir/AZT) may be used instead of d4T XR + Lamivudine (Epivir) versus 3)   Efavirenz (Sustiva) + d4T XR (or Zidovudine) + Lamivudine (Epivir) Only Sustiva, Kaletra, and d4T XR are supplied by the study. The choice of d4t XR or Zidovudine is up to the provider and patient. Purpose of this Study: Is to learn how well each of the combinations of anti-HIV drugs work for the first treatment of HIV infection. Requirements to enter study: · Viral load 2000 copies or more · No prior drug treatment for HIV or treatment of more than 7 days · Use of some medications will not be allowed · May not have a serious infection or hospitalization within 14 days of starting the study · Pregnancy or breast feeding not allowed Length of Study: 96 weeks after the enrollment of the last study participant What is involved in being a part of this study? · Visits every 4 weeks for the first 6 months and then every 8 weeks · Visits include: blood draw, review of medications, symptoms and any illnesses. · Body measurements will be done every 24 weeks · DEXA scans will be done at entry and weeks 48 and 96 · Questionnaires about how you feel, how you see your body image, and how you take medications will be completed at some of the visits   Back to top Currently on Stable Therapy ACTG 5212: (closed 4/11/2008) A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ (<200) Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy with Plasma HIV-1 RNA Levels <200 copies/mL Purpose: To determine whether one type of growth factor, palifermin (rHuKGF), a substance that promotes growth and especially cell growth, can safely increase CD4+ cell count  demonstrate a greater rise in absolute CD4+ lymphocyte count with one of the three dose regimens of palifermin compared with placebo at the week 12 time point Drug(s) Provided by the Study: Palifermin or placebo Participants will be randomized to one of four arms. Arm A: Palifermin placebo IV bolus daily x 3 days Arm B: Palifermin 20 mcg/kg IV bolus daily x 3 days Arm C: Palifermin 40 mcg/kg IV bolus daily x 3 days Arm D: Palifermin 60 mcg/kg IV bolus daily x 3 days Study Summary Sheet for Clinicians Study Summary Summary Sheet for Lay Persons ACTG 5218: (closed 2007)A randomized phase II study of therapeutic immunization and treatment interruption among persons who begin potent antiretroviral therapy within 16 days of diagnosis of acute or recent HIV infections Purpose: to test a vaccine to see if it fights HIV infection. This vaccine is for people who started anti-HIV drugs soon after they were infected with HIV. We are looking for people who were infected just a few weeks ago (acute infection) or a few months ago (recent infection). Drug(s) Provided by the Study: MRKAd5 HIV-1 gag/pol/nef vaccine or placebo WU 180: Pharmacokinetic interaction of Kaletra and Prilosec in patients with  CD4 greater than 200, on stable antiretroviral therapy that includes Kaletra for at least 90 days, viral load is less than 1000; includes 2 pharmacokinetic days that are 12 hours in length Drug(s) Provided by the Study: Prilosec (Prilosec is used to treat ulcers, gastroesophageal reflux disease (GERD or heartburn), and other conditions involving excessive stomach acid production).Pharmacokinetic interaction of Kaletra and Prilosec; includes 2 pharmacokinetic days that are 12 hours in length; Reimbursement is available. ACTG 5218: A Randomized Phase II Study of Therapeutic Immunization and Treatment Interruption Among people Who Began Potent Antiretroviral Therapy Within 16 Days of Diagnosis of Acute or Recent HIV Infection Purpose: The main purpose of this study is to test a vaccine to determine if it fights HIV infection. This vaccine is for people who started anti-HIV drugs soon after they were infected with HIV. We are looking for people who were infected just a few weeks ago (acute infection) or a few months ago (recent infection). Drug(s) Provided by the Study: Study vaccine (MRKad5 HIV-1gag/pol/nef) and matching placebo WU 180: Pharmacokinetic interaction of Kaletra and Prilosec in patients with  CD4 greater than 200, on stable antiretroviral therapy that includes Kaletra for at least 90 days, viral load is less than 1000; includes 2 pharmacokinetic days that are 12 hours in length Drug(s) Provided by the Study: Prilosec (Prilosec is used to treat ulcers, gastroesophageal reflux disease (GERD or heartburn), and other conditions involving excessive stomach acid production). A5197 (Closed to enrollment June 7, 2006) A Double-Blind, Randomized, Placebo-Controlled Phase II Study to evaluate the antiretroviral effect of immunization with the MRK Ad5 HIV-1 Gag Vaccine in HIV-1 Infected Individuals who interrupt antiretroviral drug therapy Purpose: The main objective of A5197 is to determine whether the MRK Ad5 vaccine has an effect of lowering HIV-1 RNA levels over 16 weeks post-ART interruption, versus placebo. Drug(s) Provided by the Study: MRK Ad5 HIV-1 GAG Vaccine or Placebo Flyer - PDF Clinician Summary - Word Participant Summary - Word ACTG 5223: (closed October 2005) Pharmacokinetic (PK) evaluations will be performed on plasma samples obtained prior to and up to 12 hours after the administration of the morning dose of lopinavir/ritonavir (LPV/RTV) in HIV-1-infected (39 men and 39 women) persons currently managed on LPV/RTV as part of their antiretroviral regimen Purpose: The primary objective is to compare the PK parameter, area under the concentration-time curve (AUC) of LPV between men and women currently receiving LPV/RTV Drug(s) Provided by the Study: None   A5201 (closed July 2005; closed to f/u 3/9/2006) A prospective, open-label, pilot trial of regimen simplification to Atazanavir/Ritonavir alone as maintenance antiretroviral therapy after sustained virologic suppression. Hypothesis: Simplified maintenance therapy with atazanavir and ritonavir alone after virologic suppression does not markedly increase the risk of virologic failure. Primary Objective:To evaluate the risk of virologic failure (defined as a confirmed plasma HIV-1 RNA ≥200 copies/mL) in subjects 24 weeks after treatment with ritonavir-boosted maintenance therapy alone. Design: A5201 is a prospective, open-label, multicenter, 30-week pilot trial (with follow-up continuing to 54 weeks) in HIV-1-infected subjects with virologic suppression for at least 48 weeks on their first protease inhibitor (PI)-based regimen (defined as at least 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus at least 1 PI). Prior use of nonnucleoside reverse transcriptase inhibitors is not allowed. At entry, study volunteers switch from their current PI(s) to ritonavir-boosted atazanavir for 6 weeks to monitor for adverse effects (Step 1). Subjects whose current PIs include atazanavir are eligible and will enter the study at Step 1. Subjects with a plasma HIV-1 RNA ≥50 copies/mL at week 3 and those who experience treatment-limiting adverse effects during the 6-week lead-in are discontinued from the study and are replaced. Otherwise, subjects discontinue their NRTIs at week 6 and remain on a maintenance regimen of atazanavir/ritonavir alone for the duration of the study (Step 2). Virologic failure is defined as 2 consecutive plasma HIV-1 RNA measurements ≥200 copies/mL. Subjects with HIV-1 RNA measurements ≥200 copies/mL must return within 30 days for confirmation of virologic failure, at which point real-time genotyping will be performed if the second viral load is ≥1000 copies/mL. Decisions about future antiretroviral therapy will be made according to current clinical guidelines and may include resumption of previous combination therapy. All subjects who permanently discontinue study treatment on Step 2, including those who change therapy due to virologic failure, will be followed off treatment/on study. Patient Population: HIV-1-infected study volunteers at least 18 years old, on their first PI-based regimen. Study volunteers must have had virologic suppression for at least 48 weeks. Study volunteers must have a viral load <50 copies/mL and CD4+ cell count ≥250 cells/mm3 at screening. Regimen: Atazanavir 300 mg once a day plus ritonavir 100 mg once a day. Atazanavir will be supplied by the study. Ritonavir, and the NRTIs taken during the 6-week lead-in, must be obtained by non-study prescription. WU122: (closed Fall 2004) An Open-label Pilot Study in HIV-infected individuals to evaluate metabolic effects of discontinuation of Successful Antiretroviral Therapy Brief Summary: The objective of this study is to determine the effects on metabolic abnormalities of the discontinuation of antiretroviral therapy in HIV-infected individuals with well-controlled viral replication.  HIV-infected individuals who have decided to discontinue antiretroviral therapy will be assessed before and after cessation of antiretrovirals. We will assess the short-term impact of this intervention on glucose, lipid, and bone metabolism and well as body composition.  Targeted Population: HIV-infected individuals who have been on stable, potent ART for 3 or more months with undetectable plasma HIV-1 RNA level at screening (defined as < 400 copies/mL) and who decide to discontinue therapy for any reason will be enrolled.    Primary Objective To evaluate the impact of discontinuing successful antiretroviral therapy on glucose, lipid, and bone metabolism as well as body composition. Regimen No therapeutic intervention is planned other than observation and measurement of laboratory values in patients who have planned discontinuation of antiretroviral therapy. Therapy will be reinitiated at the discretion of the patient and his/her primary care provider.  Duration: one year A5068:  closed to enrollment September 2003 A Randomized Phase I/II Pilot Study of Intermittent Withdrawal of Antiretroviral Therapy as an Immunization Strategy and Double-blinded Immunization with ALVAC-HIV vCP1452 in Subjects with Persistent CD4 Cell Counts Greater than 500 Cells/MM3 and Plasma HIV-1 RNA Levels <50 Copies/ML Brief Description: Participants will continue anti-HIV medications until scheduled periods where the medications are stopped and restarted with careful monitoring. All participants will also receive injections with either an experimental HIV vaccine or a placebo (looks like the HIV vaccine but does not contain any active medicine). Purpose of this Study:  To compare different ways to stimulate the immune system to fight off and/or kill HIV.  The study will look at HIV viral load levels and safety of the following strategies: 1.  Continue antiretrovirals for 92 weeks with one 12-20 week withdrawal period 2.  Continue antiretrovirals for 84 weeks with one 4-6 week withdrawal period, one 4 week withdrawal period, and one 12-20 week withdrawal period. 3.  Continue antiretrovirals for 92 weeks with one 12-20 week withdrawal period plus ALVAC vCP1452. 4.  Continue antiretrovirals for 84 weeks with one 4-6 week withdrawal period, one 4 week withdrawal period, and one 12-20 week withdrawal period plus ALVAC vCP1452. Requirements to Enter Study: Current, persistent CD4 more than 500 for at least 6 months before study entry Current, persistent HIV-1 RNA (viral load) less than 400 for at least 6 months before study entry Screening HIV-1 RNA (viral load) less than 50 On initial anti-HIV combination medications Not pregnant or planning to become pregnant Laboratory test results within limits described by protocol No acute medical problems or medications not allowed on the study No close contact with canaries or sensitivity/allergy to albumin or egg protein No interruption in anti-HIV medications during the year prior to study Must not have become HIV infected during the year before study entry Treatment: · Injections with ALVAC-HIV vCP1452 or with placebo will be given in 3 cycles. Each cycle lasts for 3 weeks, with one injection per week. · Cycles will be repeated two more times, 18 weeks apart, for a total of 9 injections on the study. Duration of Study: Approximately 2 years To print a summary of this study just clink on either of the links below:   Back to top  A5077: This study closed to enrollment April 2003 Virologic studies in compartmental samples for individuals changing or initiating HAART-minimum of 3 drugs (2 nucleosides and a non-nucleoside, two nucleosides and ABC, two nucleosides and a PI, two PI’s and a non-nucleoside, two PI's and a nucleoside or a nucleoside a non-nucleoside and a PI)VL >2000, willing to contribute samples of blood saliva and either genital secretions or lymphoid tissue or both.  A participant can not have active Opportunistic infections, be pregnant, and have not received  vaccines or immunomodulators within 14 days. This study is now open to only women. Back to top  A5102 "This study has closed to enrollment 12/13/02"  Pulse therapy-restarting ART +/- IL2, stable antiretroviral therapy (ART) for at least 3 months, CD4 at least 500, Viral Load (VL) less than or equal to 400 and screening VL less than or equal to 200.  No ART provided, can’t have had > 500 VL on  first HAART regimen, no active or past AIDS defining illness (KS <10 lesions), no hydrea for past 3 months, no prior IL-2.  Printer Friendly Study flyer - PDF A5116: "This study has closed to enrollment 1/22/03"  A Phase II, Randomized, Controlled Trial of Two Potent, Simplified Regimens Utilizing a Protease Inhibitor-Sparing Regimen versus a Nucleoside-Sparing Regimen for HIV-Infected Persons who Participated in ACTG 388 and have less than or equal to  200 HIV RNA Copies/ML.   A5170: closed October 2003 PREDICTORS OF PROGRESSION IN PERSONS  WITH CD4 CELL COUNTS MORE THAN 350 CELLS/MM3 WHO DISCONTINUE ANTIRETROVIRAL THERAPY. Brief Description: This study is an observational, two-step study in HIV-infected people who feel well and who wish to stop their anti-HIV therapy (ART). Purpose of this Study: Doctors find that many HIV-infected people who never had a low CD4 cell count want to stop ART. CD4 cells help fight infection. This study will try to learn if it is safe for people who feel well and have a CD4+ cell count >350 cells/mm3 to stop ART. We will look at: · how soon any complications might show up; · how soon the CD4 cell count might drop to <250 cells/mm3; · what markers in your blood might help us learn which people will fare well when they stop ART; and · whether you need medical care more or less often when you stop ART. Requirements to Enter Study:  HIV-1 infection. · CD4+ cell count >350 cells/mm3 before ever starting ART. · Plasma HIV-1 RNA <55,000 copies and CD4 count >350 within 45 days prior to entry. · Currently receiving stable ART with ³2 drugs for ³6 months. · Desire to stop ART at study entry. Treatment: Step 1 – Stopping ART · You are followed with regular visits (initially monthly then every 8 to 12 weeks) for a maximum of 96 weeks. At these visits we will see how you are doing and will obtain blood for CD4 counts, HIV viral load, blood lipid levels, and will assess your ability to think clearly. Step 2 – Restarting ART · You can restart ART at any time that you and your doctor decide it is best. · You can use any antiretroviral medications when and if you restart therapy. · Once you restart ART, you will be followed for 24 weeks or until you have been in the study for 96 weeks, whichever is longer. Note: This study does not supply any anti-HIV drugs.   Back to top WU131: (closed July 2004) An open label pilot study in HIV-infected individuals to evaluate the immunologic and virologic effects of cyclosporin A in patients after discontinuation of antiretroviral therapy. Purpose: To evaluate whether conventionally dosed Cyclosporin A (CsA) after elective discontinuation of antiretroviral therapy will prolong the time until the rebound of viremia. To evaluate the effects of conventionally dosed CsA on the magnitude of viral replication, on the kinetics of T cell subsets, as well as on markers of T cell proliferation and activation. Targeted Population: HIV infected individuals, at least 18 years of age; with immunologically and virologically well-controlled HIV infection who want to discontinue their antiretroviral therapy. Rationale: The objective of this proposal is to study whether a short course of conventionally dosed CsA following discontinuation of successful antiretroviral therapy will delay the time until viral rebound occurs and will contribute to the preservation of CD4+ cells. The two postulated mechanisms are: 1)  Cyclosporin A will inhibit HIV mediated T cell activation, and thus: a) Reduce the susceptibility of CD4+ T cells for infection with HIV b) Reduce the output of infectious virions c) Reduce the number of CD4 cells undergoing activation induced cell death (AICD) und thus slowing the decay of CD4 cells. 2)   CsA will interfere with the HIV-gag polyprotein, resulting in an increased number of noninfectious virions. By slowing the decay of CD4+ T cells via the proposed mechanisms HIV infected individuals could stay off antiretroviral therapy for longer periods of time. This would be beneficial for patients who suffer from ART associated side effects. This strategy will also lead to cost reduction and help preventing the development of HIV drug resistance. Treatment: Twelve HIV infected individuals on successful antiretroviral therapy and undetectable HIV plasma viral load who have decided to temporarily cease their antiretroviral therapy will be prospectively randomized in a 1:1 manner to one of two groups. Group A will receive conventionally dosed CsA (7.5 mg/kg/day) in two daily doses for 8 weeks right after stopping their antitetroviral therapy. Group B will discontinue antiretroviral therapy without any additional treatment and serve as control group. Patients will undergo twice-weekly determinations of plasma viral load these 8 weeks and monthly thereafter for the following 4 months and every other month for the following 6 months. T lymphocyte subsets will be determined weekly for the first 8 weeks and then in the same manner as plasma viral load. We will also assess the impact of this intervention on markers of T-cell activation and proliferation at baseline, on week 2 and 4 while patients are on CsA and on week 2 after discontinuation of CsA. Should the CD4 cell count drop below 200 cells/µL at any time, the previous antiretroviral regimen will be restarted. Duration of Study: 48 weeks   RESISTANT TO CURRENT THERAPY? ACTG 5146 (closed May 2006) A randomized controlled trial evaluating the impact of therapeutic drug monitoring (TDM) on virologic response to a salvage regimen in persons with a normalized inhibitory quotient (NIQ) <  1  to one or more protease inhibitors. Brief Summary: This study will compare the effectiveness of using increased doses of protease inhibitor (PI) drugs to continuing standard doses of PIs in lowering viral load (amount of HIV in the blood). The dose increases of the PI drugs will be based upon Therapeutic Drug Monitoring (TDM), which involves measuring blood levels of PIs. Purpose This study will see if using an NIQ (normalized inhibitory quotient), a new way of using TDM to adjust the levels of PIs in your blood, helps participants and their providers  control HIV infection in the body better than not using the NIQ and TDM drug levels. This study will also monitor the safety of increasing doses of PI drugs based on TDM. Patient Population - Individuals must have failed at least two combination regimens of anti-HIV drugs. - One of these regimens which failed to control the HIV infection, must have contained a PI. - Viral load must be greater than or equal to 2000 copies/mL. - A HIV drug resistance (viral phenotype) test will look at your HIV to see which anti- HIV drugs are likely to suppress its growth. Individuals must be resistant to at least one of the 15 drugs tested. - Individuals must be on their current anti-HIV combination medcations for at least 12 weeks. Treatment: All participants must initiate a salvage regimen at study entry (Step 1) that contains a PI.  A blood sample to measure the amount of the PI(s) the individual's system, called a trough drug level, will be drawn at week 2 to determine your NIQ.  The participant will be randomized at week 4 (step 2) based on the NIQ report. At week 4, participants with NIQ < 1 will be randomized to arms A or B: Group A (SOC): All anti HIV drugs given at standard doses Group B (TDM+SOC): PI[s] will be dose adjusted by TDM plus Standard of Care (SOC) for all other anti-HIV drugs  The participants with NIQ >1 will be randomized at Step 2 to enter arm C or to stop the study Group C: Observation (standard doses for all anti-HIV drugs) Stop the Study  All participants will receive evaluations to see how well they are taking their anti-HIV medications during the study  Step 3: Virologic Failure If the viral load at week 20 or later is greater than or equal to 1000 c/mL, thsoe participants  will be asked to return to the clinic to confirm virologic failure and will have another resistance test obtained.  If in Groups A (SOC) or C (Observation), they will be able to register to step 3 and start a new salvage regimen based on this 2nd resistance test.  If the NIQ is < 1 while on Step 3,  TDM will be performed with PI dose adjustments ·         If in Group B (TDM+SOC), participants will register to step 3 when they receive the 2nd resistance test and will start a new salvage regimen. If NIQ is < 1 while on Step 3, participants will also receive TDM with PI dose adjustments   Duration of Study: 48 weeks To print a summary of this study just clink on the links below: 5146 participant summary - PDF  5146 clinician summary - PDF WU 164: (closed May 2006) A multicenter, randomized, double-blind, placebo-controlled trial of a novel CCR5 antagonist, UK-427,857, in combination with optimized background therapy (OBT) versus optimized background therapy alone for the treatment of antiretroviral-experienced HIV-infected persons. Purpose: To determine if UK-427,857 when added to OBT will cause a decrease in HIV viral load that is greater than OBT alone. Drug(s) Provided by the Study: UK-142,857 and matching placebo A5211 (closed sept 20, 2005) An phase II, randomized, double-blind study of the safety and efficacy of SCHE 417690 in HIV-infected, treatment-experienced patients. Purpose: To evaluate the virologic activity over 14 days of 3 dose levels of SCH 417690 in HIV-infected, treatment-experienced subjects who are failing their current ritonavir-containing antiretroviral regimen. SCH 417690 (formerly, Schering D) is an inhibitor of HIV‑1 infection that acts by specifically blocking the CCR5 co receptor. Drug(s) Provided by the Study: three doses of SCH 417690 and matching placebo NOTE: The AIDS Clinical Trials Group has a special arrangement with Abbott Laboratories , to allow A5211 patients with financial hardship (e.g., inability to access, pay for, or pay the co-payments for ritonavir for the A5211 study) can obtain ritonavir directly from the Virology Patient Assistance Program at Abbott Laboratories. Our pharmacist will assist in completion of these applications for A5211 participants. To print a summary of this study just clink on the link below: 5211 Clinician Summary - PDF Participant Summary Sheet - Word WU 165: (closed July 2005) An open label, non-randomized treatment protocol of Tipranavir co-administered with low-dose ritonavir (TPV/r) in protease inhibitor-experienced patients with HIV infection (the Tipranavir expanded access program) Purpose: To provide Tipranavir to be taken with ritonavir to patients that have resistant HIV infection and who now have very few treatment options available and do not qualify for or have access to other Tipranavir research studies. This study will also assess the safety and tolerance of long-term administration of Tipranavir with ritonavir. Drug(s) Provided by the Study: Tipranavir only A 5165: (closed April 2005) A Phase I/II randomized, double-blind, placebo-controlled pilot study of B-D-2,6-DIAMINOPURINE DIOXOLANE (DAPD) versus DAPD plus Mycophenolate Mofetil (MMF) in treatment-experienced patients. Purpose: This study, using beta-D-2, 6-Diaminopurine Dioxolane (DAPD) and Mycophenolate Mofetil (MMF), is for people who have experienced at least 3 classes of HIV meds and are looking for new options. DAPD is a novel NRTI that may be beneficial against NRTI-resistant HIV. MMF may enhance the activity of selected NRTIs, such as DAPD, against both wild type and certain NRTI-resistant HIV. This study is being done to assess the safety and efficacy of DAPD as compared to DAPD plus MMF in people who have taken various HIV medications in the past but have HIV resistant to most available medications. Drug(s) Provided by the Study: DAPD and Mycophenolate Mofetil (MMF) or MMF placebo, T20 5165 participant summary - Word 5165 clinician summary - Word ACTG 5201: (closed March 2005) is a prospective, open-label, 30-week pilot trial of regimen simplification to Atazanavir/Ritonavir (ATV/RTV) alone as maintenance ARV therapy after sustained virologic suppression. Purpose: To evaluate the risk of virologic failure in subjects 24 weeks after treatment with ATV/RTV maintenance therapy alone. Virologic failure is defined as 2 consecutive plasma HIV-1 RNA measurements ≥ 200 copies/mL. Several small studies have suggested that ritonavir-boosted protease inhibitors alone may be sufficient to control viral replication. This will be the first study using boosted atazanavir alone, which has the advantages of being dosed once daily and not causing lipid abnormalities. Drug(s) Provided by the Study: ATV 300 mg QD plus RTV 100mg QD. ATV and RTV will be supplied by the study; NRTIs will not be supplied by the study. ACTG 5126  (closed Feb 2005) Primary Objectives Evaluate the correlation between the Inhibitory Quotient (IQ) ratios for each PI and the short-term antiretroviral activity of the PI combined with ritonavir in individuals with failure of previous PI-based regimens. Evaluate the correlation between the IQ ratios and the long-term antiretroviral activity measured by the change in HIV-1 RNA from baseline to week 24. Regimens A) Indinavir 800 mg and ritonavir 200 mg BID. B) GW-433908 700 mg and ritonavir 100 mg BID. C) Lopinavir/r 400mg/100 mg plus ritonavir 100 mg BID. On day 15 (the day following the 12-hour PK study), all patients will also receive Tenofovir 300 mg QD. Major Inclusions HIV-1 RNA >2,500 copies/mL on 2 separate occasions >/= 8 weeks apart. Antiretroviral history: • one or more PI regimens for at least 52 weeks, without change in previous 14 weeks prior to entry. • NNRTI with two or more NRTIs for at least 12 weeks anytime in prior history. ANC >/= 750; Hgb >/= 7.0; platelets >/= 50,000; creatinine < 1.5 x ULN; phosphate >/= 2.0; AST, ALT, alkaline phosphate </= 5x ULN; total bili </= 2.5x ULN; lipase </= 2.0x ULN, fasting TG </= 1200. Major Exclusions H/O treatment with RTV, APV, LPV/r, or IDV if not currently on; also h/o intolerance to above meds. H/O NFV as only PI anytime prior to study entry. Current treatment with 3 or more PIs, DLV, HU. Use of investigational agents, HIV vaccines &/or immunotherapies within 60 days of study entry. H/O significant renal disease. Active drug or alcohol use or dependence that in the opinion of the investigator would interfere with compliance. Serious systemic illness requiring treatment within 14 days of entry. Inability to quantify fold-change in IC50 to IDV, LPV, APV. Duration 24 weeks   A5165 (closed March 2005) A Phase I/II randomized, double-blind, placebo-controlled pilot study of b-D-2,6-Diaminopurine Dioxolane (DAPD) versus DAPD plus Mycophenolate Mfetil (MMF) in treatment-experienced patients. Brief Summary: This study, using beta-D-2, 6-Diaminopurine Dioxolane (DAPD) and Mycophenolate Mofetil (MMF), is for people who have experienced at least 3 classes of HIV meds and are looking for new options. DAPD is a novel NRTI that may be beneficial against NRTI-resistant HIV. (MMF) may enhance the activity of selected NRTIs, such as DAPD, against NRTI-resistant HIV. This study is being done to find out whether the use of beta-D-2, 6-Diaminopurine Dioxolane (DAPD) VS DAPD plus Mycophenolate Mofetil(MMF) has anti-HIV activity in people who have taken various HIV medications in the past. Patient Population: -Extensive prior antiretroviral exposure (has failed 3 classes of HIV meds, ask  study staff for details) and currently on failing regimen for at least 30 days -CD4 greater than 100 -Viral load greater equal to or greater than 2,000 -Must not have taken abacavir within 30 days of starting study -No active opportunistic infection Study Volunteers Receive: -DAPD and MMF provided by the study. -Lab work Duration of Study: 48 - 96 weeks; one year follow up after discontinuation of study medications.   WU 132  Capravirine (closed to further enrollment on August 15, 2003) This study is for people who have failed antiretroviral regimens containing protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and nucleoside reverse transcriptase inhibitors. This study will compare Capravirine in combination with Kaletra and at least 2 nucleoside reverse transcriptase inhibitors.  Patient Population: - HIV-infected individuals 18 years or older - HIV RNA greater than 1000 copies - failed antiretroviral regimens that included at least 1 but no more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and at least 2 nucleoside reverse transcriptase inhibitors. - never taken Kaletra or Capravirine Study Objective: To compare capravirine in 3 different doses (200, 400, or 700 mg twice a day) in combination with Kaletra with the use of Kaletra alone. In addition, everyone will receive at least 2 nucleoside reverse transcriptase inhibitors (NRTIs). Study Scheme: all patients will have genotypic and phenotypic resistance testing Double-Blinded, Placebo Controlled Randomized to receive capravirine (200, 400, or 700 mg twice a day or placebo) plus  Kaletra and 2 NRTIs. - all patients get Kaletra and two NRTIs - NRTIs are not provided by the study Duration: 48 weeks rollover in open label capravirine study planned after 48 weeks Study Drugs: Capravirine, CPV Kaletra. LPV/rtv 2 NRTIs (not provided) Study Status: Active Study, Open for enrollment  Study Volunteers Receive - Lab work provided for free - Transportation reimbursement when needed - Kaletra and capravirine provided for free, NRTI is not provided by the study   WU 135   Tipranavir  closed to enrollment5/21/03  This study is for HIV+ people who have been treated with multiple antiretroviral drugs (each of the 3 classes of antiretrovirals). This study will compare tipranavir boosted with low-dose ritonavir versus the best choice of treatment as determined by genotypic screening (measuring the virus’ susceptibility to different medications) and a panel of HIV-resistance consultants.  Patient Population:  · HIV-infected individuals  · HIV RNA greater than 1000 copies (a measure of the level of HIV in the blood, indicating that the current regimen has lost its effectiveness against HIV).  · previously received treatment from each of the 3 antiretroviral classes that included at least two Protease Inhibitor (PI)-based regimens  · on a PI-based regimen at the time of study entry  Study Objective:  To compare Tipranavir/Ritonavir with the best standard of care regimen based on resistance screening  Study Scheme:  Randomized, open label, to receive tipranavir boosted with low-dose ritonavir versus genotypically-defined protease inhibitor/ritonavir.  Duration: 48 weeks  Study Drugs:  Tipranavir (TPV)  Ritonavir (RTV, Norvir)  Study Status:  Active Study, Open for enrollment  Study Volunteers Receive  · All study medications (tipranavir/ritonavir or other PI/ritonavir); If the volunteer is not insured, the sponsor will also provide appropriate non-PI anti-HIV drugs (background antiretrovirals) at no charge to the volunteer.  · Lab tests including genotypic screening provided for free  · Transportation reimbursement when needed WU 141  (Closed July 2005) An open label safety study (expanded access) to evaluate the safety of tipranavir plus ritonavir when used in combination with other agents for the treatment of patients with HIV infection who have failed and/or are intolerant to combination antiretroviral therapy and have limited treatment options Purpose: This open label safety study to obtain an experimental drug called tipranavir in individuals who have either failed or did not tolerate other anti-retroviral therapeutic regimens and now have very few treatments options available to treat HIV infection. The purpose of this open label safety study is to provide tipranavir to be taken with Ritonavir to patients that have advanced HIV infection and who now have very few treatment options available and do not qualify for other tipranavir research studies. Drug Supply: Patients will receive initially a one-month supply of tipranavir (a bottle containing 120 capsules). Tipranavir will be supplied by the study physician on a monthly basis. Ritonavir and other antiretroviral agents will not be provided by the study and will have to be co-prescribed by the primary HIV physician or the study physician. WU 161: (Closed April 2005)Randomized double-blind, placebo-controlled trail of a novel CCR5 antagonist, UK-427,857, in combination with optimized background therapy (OBT) vs optimized background therapy along for the treatment of ART experienced non-CCR5 tropic patients. Purpose: To determine if UK-427,857 when added to OBT will cause a decrease in viral load that is greater than OBT along Drug Provision: Pfizer entry inhibitor only Back to top Metabolic, Cardiac Complications and Symptom Management ACTG 5229: (closed May 2008) A phase II/III, randomized, double-blind, placebo-controlled trial of uridine supplementation in HIV lipoatrophy Purpose: The main objective of A5229 is to examine the effect of uridine supplementation on limb fat in HIV-1 infected patients with established lipoatrophy, by comparing changes in DEXA-measured limb fat from baseline to week 48. The study will also determine whether there are changes in HIV-RNA levels, CD4 cell count, venous lactate, insulin, and fasting lipids from baseline through week 48. It will also examine the safety and tolerability of the supplement in HIV-1 infected persons; as well as the effects of uridine supplementation on oxidant stress. Drug(s) Provided by the Study: NucleomaxX or the placebo Study Volunteers Receive: Facial anthropometrics (fat fold measurements of three different parts of the face), a body image questionnaire, whole body DEXA scan. Provider Summary Sheet - Word Participant Summary Sheet - Word WU 187: (closed May 2008) HathaYoga lifestyle intervention for HIV metabolic syndromes. Purpose: To examine whether practicing yoga improves sugar tolerance and body fat distribution, and reduces serum cholesterol and cardiovascular disease risk in people living with HIV who are experiencing these metabolic changes. Volunteers are randomly assigned to either 4 months of yoga + standard-of-care, or 4 months of standard-of-care (placebo) followed by 4 months of yoga + standard-of-care. The yoga intervention will be individualized to each participant and provided by certified yoga instructors. Study Volunteers Receive: 1 month nutrition counseling, 4 months yoga, assessments of body composition, blood sugar and lipids, cardio respiratory capacity, and payment for time/effort, and travel support.   WU 204: (closed May 2008) An open-label, multicenter trial to compare the efficacy, safety, and tolerability of PREZISTA/r by Gender and Race, when administered in combination with an individually optimized background regimen over a 48 week treatment period (GRACE). Purpose: The purpose of this research study is to look for any differences in how effective PREZISTA/r is in treating HIV infection by sex (women versus men) as well as by race (i.e. Caucasian vs. Black vs. Hispanic/Latin). This study will also evaluate the safety (side effects) and tolerability of PREZISTA/r by sex and race. PREZISTA (600mg) taken with ritonavir (100mg) twice a day is the drug combination being studied. Drug(s) Provided by the Study: Prezista (darunavir), TMC-125, Truvada, Viread, Emtriva, AZT, Norvir  WU 171: HIV, endothelial dysfunction, and insulin resistance: a prospective observational study of endothelial dysfunction and insulin resistance in HIV-infected persons to determine potential effects over time associated with any particular class of HIV drug. To determine if tests performed could be useful in predicting heart disease and/or diabetes prior to their actual development. Drug(s) Provided by the Study: None; Tests provided include: DEXA, glucose tolerance test, brachial (arm) artery ultrasound once per year for three years; compensation is provided. A5206: A Pilot study to determine the impact on dyslipidemia of the addition of Tenofovir to stable background antiretroviral therapy in HIV-infected persons.  Purpose: To evaluate the decline in non-HDL levels after the addition of TDF to a stable background HAART regimen for 12 weeks compared with the change in non-HDL after 12 weeks of placebo for TDF.  Drug(s) Provided by the Study: Tenofovir or matching placebo only A5209: A pilot study of the safety, efficacy, and tolerability of Ezetimibe in combination with statin therapy for the treatement of elevated LDL cholesterol in HIV-infected persons. Must be on HAART. Brief Description: This is a blinded, cross-over study adding Ezetimibe (Zetia) to the Statin medication currently being used for the treatment of high LDL (‘bad’) cholesterol. A cross-over study means that the participant will take ezetimibe for half of the study and a placebo for the other half of the study. Purpose of this Study: To learn how safe and how well tolerated it is to take Ezetimibe (Zetia) in combination with HIV and Statin medications in people who are HIV infected, and how well it works to lower LDL cholesterol. Requirements to Enter Study: • Must have taken Statin and anti-HIV medications for at least the 3 months before entering study, and have had no changes in the way they are taken for at least 30 days before entering study Treatment: Arm A: Ezetimibe once a day for 12 weeks, followed by 4 weeks of not taking any study treatment, followed by 12 weeks of taking Placebo for Ezetimibe once a day. Arm B: Placebo for Ezetimibe once a day for 12 weeks, followed by 4 weeks of not taking any study treatment, followed by 12 weeks of taking Ezetimibe once a day. Duration of Study: 28 weeks Drug(s) Provided by the Study: Ezetimibe (Zetia) and placebo Clinician Summary Participant Summary WU144: (closed December 2005) This study will help to determine if taking HIV-protease inhibitors (PIs) has an effect on the body’s ability to utilize fat for energy during rest and low-intensity exercise.  Information from this study may provide insight into the causes of metabolic complications (i.e. abdominal fat accumulation, high blood sugar) associated with PI therapy in people living with HIV.  ACTG 5209: (closed June 2005) A Pilot Study of the Safety, Efficacy, and Tolerability of Ezetimibe (ZETIA®) in Combination with Statin Therapy for the Treatment of Elevated LDL Cholesterol in HIV-infected patients Purpose: To evaluate the change in directly measured LDL-c after the addition of ezetimibe to a stable background of HAART and statin therapy for 12 weeks compared with the change in LDL-c after 12 weeks of placebo. Drug(s) Provided by the Study: Zetia and matching placebo.   WU 89:  Muscle and Adipose Metabolism in HAART Brief Summary: Determine the pathogenesis of diabetes, dyslipidemia and fat re-distribution in people living with HIV. This is a cross-sectional study comparing HIV-infected patients with metabolic complications to HIV-infected patients not experiencing metabolic complications despite treatment with similar medication regimens. Targeted Population: Patients who are on stable antiviral therapy for at least 6 months prior to enrollment and have a viral load less than 50,000 and CD4 greater than 200. Sedentary lifestyle (less than 3 hours per week regular exercise).   A5186 closed to enrollment 1/11/2005 This study will use a combination of fish oil, a dietary supplement, and fenofibrate, a medication used for treatment of high cholesterol. The study will help to determine the benefit and safety of these medications in HIV infected people taking anti-HIV drugs who have high levels of triglycerides. Brief Summary: This study will help us determine how safe it is to take fish oil and fenofibrate either alone or together and how well they work to lower triglycerides in people with HIV that have high triglycerides. Objectives: 1. To evaluate whether the combination of fish oil supplement and fenofibrate will decrease serum TG’s to ≤200 mg/dl in subjects not responding to either agent alone. 2. To evaluate the safety and tolerability of fish oil supplement alone or in combination with fenofibrate in an HIV infected population with elevated serum TG’s. Requirements to Enter Study: • Men and women >18 years old • Fasting (no food for 8 hours) Triglycerides (TG) >400 mg/dl • Fasting LDL (type of cholesterol) measured by the study <160 mg/dl • Must be taking anti-HIV drug therapy for 3 months before study • Must not take any drugs to decrease cholesterol or triglycerides 28 days before study Treatment: Step 1: ALL VOLUNTEERS have an equal chance of getting EITHER: Arm A: Fish oil supplement (taken twice a day) OR Arm B: Fenofibrate (once a day) Step 2: • Volunteers that have TG’s ≤200 mg/dl after 8 weeks will stay on same treatment through week 18 • Volunteers that still have TG’s >200 mg/dl will have the other study treatment added at week 10 and will stay on it through week 18. All volunteers will stop study treatment at week 18 and will return to the clinic for a follow-up visit 4 weeks later. Drug provision: Fenofibrate and Fish Oil supplement Duration of Study: 22 weeks click for clinician summary A5186 PDF.     A5079:  This study  is designed to find out whether treatment with testosterone gel will reduce the amount of extra fat in the abdominal area and whether it is a safe treatment for men with HIV. To participate you must be an HIV-positive man with abdominal obesity, on stable treatment for HIV infection and have low levels of testosterone in your blood.  All patients on study treatment at the conclusion of double-blind phase will be eligible to receive open label testosterone. A5082:  (closed March 2004) A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF METFORMIN AND ROSIGLITAZONE, ALONE OR IN COMBINATION, IN HIV-INFECTED SUBJECTS WITH FASTING HYPERINSULINEMIA AND ELEVATED WAIST/HIP RATIO Brief Summary: This is a randomized, double-blind, placebo-controlled study of metformin and rosiglitazone, alone or in combination, in HIV-infected subjects who have developed fat redistribution and fasting hyperinsulinemia during the course of their HIV disease. Objectives: ·-To determine the effects of metformin and rosiglitazone, on fasting insulin levels and insulin AUC in response to an oral glucose tolerance test by comparing each active treatment group to placebo treatment. ·-To determine the effects of metformin and rosiglitazone, alone and in combination, on visceral fat area by comparing each active treatment group to placebo treatment. ·-To evaluate the safety of rosiglitazone and metformin alone and in combination. Treatment: Arm A: Metformin 500 mg po Q 12h daily for 2 weeks, then Metformin 1000mg po Q 12h + Rosiglitazone placebo po once daily Arm B: Metformin 500 mg placebo po Q 12h daily for 2 weeks, then Metformin 1000mg placebo po Q 12h + Rosiglitazone 4 mg po daily Arm C: Metformin 500 mg po q 12h for 2 weeks, then Metformin 1000 mg po Q 12h daily + Rosiglitazone 4 mg po daily Arm D: Metformin placebo 500 mg po Q 12h daily for 2 weeks then Metformin placebo 1000mg po Q 12h + Rosiglitazone placebo po once daily. After completion of the week 16 evaluations, patients who are still on study drugs will be switched to the open-label combination of metformin plus rosiglitazone. (Metformin 500mg po Q 12h for 2 weeks, then Metformin 1000mg po Q 12h + Rosiglitazone 4 mg po daily. Duration of Study: 32 Weeks   A5110:  (closed March 2004) A Restrictively Randomized, Open-Label, Controlled, Pilot Study of the Effect of a Thymidine Analogue Substitution or Change to a Nucleoside-Sparing Regimen on Peripheral Fat Wasting Brief Description: This study will examine if thinning of the face and arms [lipoatrophy] during the course of HIV treatment is reversible if AZT and d4T are stopped and Abacavir is substituted, or all nucleosides are stopped (AZT, d4T, 3TC ,ddI, ddC, Abacavir  ) and replaced with a protease inhibitor and non-nucleoside regimen (Kaletra plus Viramune.) Purpose of this Study To try to find out if weight loss in the arms and legs is caused by one type of anti-HIV drug and if this weight loss can be reversed if that type of drug is stopped and replaced with other types of HIV-drugs. Requirements to Enter Study: ·        You and your doctor have noticed a change in your body fat. Your arms and legs have lost fat and your abdominal area has gained fat. ·        Viral load < 50 copies/ml. ·        Men and women > than 13 years old. ·        You must be taking potent anti-HIV medications including AZT or d4T for 24 weeks or longer. ·        CD4 count > 100. ·        No blood sugar lowering medications. ·        Some medications may not be allowed. ·        Readable CT scan of the mid-thigh and abdomen. Treatment: All volunteers have an equal chance of getting one of the following treatments except volunteers who are, or have been, taking Abacavir. Those volunteers will be assigned to Arms B1 or B2. Treatment Regimens:   Arm A-1 You switch immediately: Stop AZT or d4T -- add Abacavir. You continue the rest of the medicines in the combination you are taking. Arm A-2 You wait 28 weeks before switching and then: Stop AZT or d4T -- add Abacavir.You continue the rest of the medicines in the combination you are taking. Arm B-1 You switch immediately: Stop the medicines you are now taking. You start Kaletra and Viramune. Arm B-2 You wait 28 weeks before switching and then: Stop the medicines you are taking -- start taking Kaletra and Viramune. Duration of Study: Persons randomized (like a flip of a coin) to Arm A1 and B1 will be followed for 48 weeks on study. Persons randomized to Arm A2 and B2 will be followed for 76 weeks on study. To print a summary of this study just clink on either of the links below:   A5148:   A Pilot Study of the Safety, Efficacy, and the Tolerability of Extended-Release Niacin (Niaspan ®) for the Treatment of Elevated non-HDL Cholesterol and Elevated Triglycerides in HIV-Infected Subjects Brief Summary: This is a 48-week, single-arm, open-label, dose-escalating protocol designed to study the safety, efficacy, and tolerability of extended-release niacin (Niaspan ®) in HIV-infected individuals with elevated triglycerides and elevated non-HDL-cholesterol (non-HDL-C). Purpose: Determine the safety and tolerability of extended-release niacin (Niaspan ®) therapy over 44 weeks of lipid goal-directed therapy, including the effect on: §         ALT/AST levels §         Fasting glucose and insulin §         Fructosamine §         Development of worsening oral glucose tolerance and diabetes mellitus §         Insulin sensitivity estimated by log HOMA-IR (43) Targeted Population: Thirty HIV-infected individuals with elevated triglycerides (≥ 200 mg/dL) and elevated non-HDL-C (≥ 180 mg/dL). Treatment: After a lipid-lowering diet lead-in and activity guide of 4 weeks, extended-release niacin (Niaspan ®) will be dose escalated with increases of 500 mg every 4 to 6 weeks over a 16-week period to a daily final dose of 1000 to 2000 mg.  The dose escalation and final dose will be dependent on a composite lipid goal of non-HDL-C of < 160 mg/dL, LDL-C of < 130 mg/dL, triglycerides of < 500 mg/dL, and drug tolerability. Duration of Study: 48 weeks (4 weeks of lipid-lowering diet and activity guide lead-in followed by 44 weeks of lipid goal-directed drug therapy).   A5163 (closed to enrollment 8/27/04; closed to follow up 2/3/2006) A phase II, randomized, double-blind, placebo-controlled study of once-weekly alendronate in HIV-positive persons with decreased bone mineral density receiving calcium and vitamin D.  Purpose:  This study is being done to find out if alendronate, plus calcium and vitamin D, is well tolerated, effective, and safe to treat bone loss in people infected with HIV. Alendronate is a drug approved by the FDA to treat or prevent bone loss. Alendronate is not approved for the treatment of bone loss related to HIV infection or its treatment.  Patient Population:  -HIV-positive men and women of at least 25 years of age, with decreased bone mineral density as documented by DEXA Scan -Plasma HIV-1 RNA level of 5000 or less and a CD4 count of 100 or more -Must be receiving HIV therapy  Study Objective:  -To see if a weekly dose of alendronate and daily calcium and vitamin D are effective in the treatment of HIV-associated loss of bone density.  Study Scheme:  Everyone will receive calcium and vitamin D, to be taken as a single pill twice a day. Patients will be randomized (assigned by chance, as if by the toss of a coin) to receive once a week either alendronate or a placebo (a placebo is a tablet that looks like the active drug, but has no active drug in it. It is like a sugar pill).  Study Drugs:  Alendronate (Fosamax)  calcium and vitamin D   Study Status:  Active Study, Open for enrollment   Study Volunteers Receive  -Provides DEXA Scan [results available at the end of the study] and other free screening to find out if you have thinning of your bones  -Alendronate or Alendronate placebo -calcium and vitamin D  Drug Provision: Alendronate & matching placebo, Calcium Carbonate with Vitamin D  Duration: 48 weeks  flyer for men - PDF  flyer for women - PDF WU 120  (closed October 2004) STOP-IT: An