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Need more detail about a protocol?
Click on any highlighted or underlined link to go to the protocol
summary page when available.
To view studies that are being conducted, but are no longer enrolling
participants click on "Closed Studies".
Primary Infection
HIV Negative
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Antiretroviral Naive
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On
Stable Therapy
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Resistant to Therapy |
Side Effects/Metabolic Complications|
Desire to Stop Medicines
NAÏVE TO MEDICATIONS (Have not started therapy for HIV):
There
are studies at Washington University ACTU for individuals ready
to start treatment for HIV.
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A5217:
This study will compare the
virologic setpoint 72 weeks after study entry in individuals with recent
but not acute HIV-1 infection who are randomized to receive antiretroviral
therapy with individuals who are randomized to not receive antiretroviral
therapy. |
A5248: First-Phase Viral Decay Rates in
Treatment-Naïve Subjects Initiating Treatment with Raltegravir (RAL) and
Emtricitabine (FTC)/Tenofovir
Disoproxil Fumarate (TDF): A Pilot Study |
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WU 198:
Autonomic nervous system activity in HIV |
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READY TO START TREATMENT?
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A 5217: A
Randomized Study of Treatment with Tenofovir DF, Emtricitabine, and
Lopinavir/Ritonavir versus no Therapy in Newly Infected HIV-1 Infected
Subjects to Determine Whether Potent Antiretroviral Therapy Alters the
Virologic Setpoint
Purpose: To compare the virologic
setpoint 72 weeks after study entry in individuals with recent but not
acute HIV-1 infection who are randomized to receive antiretroviral therapy
with individuals who are randomized to not receive antiretroviral therapy.
In addition, to compare the virologic setpoint 36 weeks after treatment
discontinuation in individuals randomized to treatment (72 weeks into
study) with virologic setpoint 36 weeks after study entry in individuals
randomized to no treatment.
Drug(s) Provided by the Study:
emtricitabine, Loprinavir/ritonavir, and
tenofovir DF
A 5248: First-Phase
Viral Decay Rates in Treatment-Naïve Subjects Initiating Treatment with
Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF):
A Pilot Study
Purpose: The purpose of this study is
to learn-
• How well this combination of drugs lowers the amount of HIV in the blood
( viral load),
• How well this drug combination is tolerated,
• How safe this combination of drugs is.
Drug(s) Provided by the Study:
Isentress will be provided by the study.
Provider Summary
Sheet
Participant Summary
Sheet
Recruitment Flyer
WU
198: Autonomic Nervous System Activity in HIV.
Observational study examining the effect of untreated HIV infection on fat
breakdown and the autonomic nervous system
Drug(s) Provided by the Study: None
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CURRENTLY ON STABLE THERAPY:
STABLE
BUT THINKING ABOUT STOPPING YOUR MEDS? BELOW ARE STUDIES THAT WILL ALLOW
FOR INTERRUPTION OF THERAPY: (click on "underline" text to see
more details of a study).
There are several studies at Washington University ACTU
that will monitor you closely while off medications.
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5244: Treatment intensification |
| WU 212: |
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Are
you considering stopping your HIV medications?
Let us Help You
Do it Safely!
If you have an undetectable viral load and you are thinking about
discontinuing meds, you may qualify to participate in clinical trials
that will monitor your CD4 and Viral Load very closely.
Qualified participants will receive free medical evaluations including
a physical exam, laboratory tests and study related medications.
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ACTG 5244:
A Double-Blind, Randomized, Pilot Study to Measure the Effect
of Treatment Intensification with a Potent Integrase Inhibitor,
Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia below 50
copies/mL in Subjects on Protease Inhibitor- or Nonnucleoside Reverse
Transcriptase Inhibitor-Containing Regimens
Brief Description and Purpose of this study:
The purpose of this study is to find out whether adding an
investigational drug called raltegravir lowers the amount of HIV in your
blood using a sensitive test called a single copy assay. Raltegravir is a
new drug that blocks HIV in a different way than current HIV medicines.
This study will focus on HIV-infected people who have “undetectable” viral
load. Most people who are told that they have “undetectable” viral loads
still have HIV that can be measured in their blood using a sensitive test
called the single copy assay (SCA). This is because regular viral load
tests only measure down to 50 copies of HIV in each cc of blood whereas
the SCA measures down to 1 copy in each cc of blood. In this study we will
measure the amount of HIV in your blood using the SCA before and after you
add raltegravir to your current HIV medicines. We are also trying to find
out if adding raltegravir to your HIV medicine causes any side effects or
problems. If raltegravir lowers the amount of HIV in your blood, this may
lead to other studies on how to prevent HIV from persisting in people with
the infection.
Treatment: All people who enroll in
this study will add raltegravir to their current HIV medicines: half of
the people add raltegravir for the 1st 12 weeks, and then take placebo for
12 more weeks; half add placebo for the first 12 weeks and then take
raltegravir for 12 more weeks. All patients continue their current HIV
medicines. The study lasts 6 months, and you will be required to come in
for 9 study visits during those 6 months. At those study visits, you will
have blood tests to measure the effect of the medicine on the amount of
HIV in your blood.
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RESISTANT TO CURRENT THERAPY?
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A5241:
include or omit NRTIs |
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WU 212:
MVA HIV multiantigen vaccine |
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You’ve
tried most of the
HIV drugs….
Now what?
If HIV
medications are not working for you, you may still have options.
How important are drug levels in predicting how well
you do with therapy? This is a question that needs your participation
in order to find the answer. Ask your doctor about resistance testing
and measuring drug levels in the blood to predict the ability to lower
your viral load. Your treatment will be reviewed and suggestions made
by a team of experts in
HIV/AIDS care.
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ACTG 5241:
The Optimized Treatment that Includes or Omits NRTIs
(OPTIONS) Trial: A Randomized Strategy Study for HIV-1 Infected
Treatment-Experienced Subjects Using the cPSS to Select an Effective
Regimen.
Purpose: This study will look at
whether new drugs are safe and effective in a group of HIV- infected
people whose current HIV medicines are not working. The study will also
test whether a combination that does not include an older type of medicine
called nucleoside reverse transcriptase inhibitors (NRTIs) is as good as a
combination of anti-HIV drugs that does include NRTIs. The study will also
test whether a resistance test score called the cPSS is able to predict
which drugs will work best in people whose virus is resistant to older
medicines.
Study Drugs: The anti-HIV drugs that
will be provided through the study are: enfuvirtide, raltegravir,
darunavir, tipranavir, etravirine and maraviroc. Which of these drugs are
recommended for you depends on the results of the testing done in the Part
One of the study. Although they may be recommended by the study doctors,
NRTIs and ritonavir will not be provided through the study; you will have
to get these on your own.
5241 Participant Summary
WU 212: Phase I vaccination study testing
the safety and reactogenicity of a recombinant MVA HIV multiantigen
vaccine (MVA-mBN120B) in HIV-infected persons with
CD4 count >350.
Drug(s) Provided by the Study:
MVA HIV multiantigen vaccine
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Metabolic,
Cardiac Complications and Symptom Management
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WU 157
Exercise and Pioglitazone for HIV metabolic syndromes |
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WU 197:
Myocardial function and free fatty acid metabolism in
HIV-metabolic syndrome |
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WU 198:
Observational study examining the effect of untreated HIV
infection of fat breakdown and autonomic nervous system |
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WU 207:
HIV Neurocognitive Disorders |
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You
are experiencing side effects from your current therapy....
Now what?
Several
complications have become prevalent in people living with HIV/AIDS,
including increased blood sugar, increased blood fats and cholesterol,
and fat tissue redistribution. The causes of these complications are
not well understood and effective treatments have not been identified.
The ACTU offers
studies to help us understand the complications associated with highly
active antiretroviral therapy and studies that look at ways to treat
the most common side effects.
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WU 157: Exercise
and Pioglitazone for HIV metabolic syndromes
Purpose: This study examines the
effect of exercise and study drug, Pioglitazone (PIO), on metabolic
syndromes that often affect people living with HIV. Volunteers are
randomly assigned to receive 4 months of PIO with or without exercise
training. Objectives are to determine which is more effective at
improving insulin resistance, and reducing visceral fat content, and
increasing subcutaneous fat content.
Drug(s) Provided by the Study:
Pioglitazone Study Volunteers Receive:1 month nutrition counseling, 4
month supervised gym membership, DEXA/MRI/MRS scans for body fat
content, EKG, graded exercise test, payment for time and effort.
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WU 197: Myocardial Function and Free
Fatty Acid Metabolism in HIV-Metabolic Syndrome.
Drug(s) Provided by the Study:
randomized to pioglitazone or exercise (50%/50%).
WU 198:
Autonomic Nervous System Activity in HIV. Observational study
examining the effect of untreated HIV infection on fat breakdown and
the autonomic nervous system. Ideally patients will be starting
antiretroviral therapy within 3 months of participating in the study
(if clinically indicated or if participating in a treatment study such
as ACTG 5202; treatment is not provided by this study).
Drug(s) Provided by the Study:
None
WU 207: HIV Neurocognitive
Disorder: A Randomized Clinical Trial of CNS-targeted HAART to
determine if a regimen that crosses the blood brain barrier helps with
cognitive dysfunction in patients who are mildly impaired compared to
those taking a regimen that does not cross over. Naïve patients are
also eligible for this study.
Purpose: This study will help to
learn more about HIV and antiretroviral therapy that affects the
brain. HIV in the brain in some people leads to difficulties with
memory, concentration and coordination. This study compares different
forms of therapy for HIV to see which may be best to treat the brain.
This study seeks patients who have never been treated and those who
are considering starting or changing antiretroviral therapy.
Drug(s) Provided by the Study:
None; Participants will be compensated up to $785 for study
participation.The study does include lumbar punctures.
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Opportunistic
Infections
There are currently
no studies at Washington University ACTU for individuals who are
experiencing a specific opportunistic infection.
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Experiencing
an Opportunistic Infection?
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AIDS Associated
Cancers
No studies listed at this time.
Neurologic Complications
There are studies at
Washington University ACTU that will offer options if you are
experiencing neurological complications with HIV.
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A5235: Minocycline in the
treatment of HIV-associated cognitive impairment |
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The Neurologic AIDS Research Consortium (NARC) is supported by the National Institutes
of Health to design and carry out clinical trials to improve the therapy for HIV induced
neurologic disease, and neurologic conditions associated with the HIV.
The NARC primarily sponsors studies in conjunction with the
AIDS Clinical Trials Group Studies
currently available including treatment trials for AIDS dementia complex, peripheral
neuropathy, and progressive multifocal leukoencephalopathy. Persons interested in
treatment for neurologic HIV complications should contact contact Mary Gould,
NARC Coordinator, by email at gouldm@neuro.wustl.edu or by phone at
314-362-9733.
Visit their website at
www.neuro.wustl.edu/narc/
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ACTG 5235:
1/8/2007 Phase I/II,
Placebo-Controlled, Double-Blind Study of Minocycline in the Treatment of
HIV-Associated Cognitive Impairment
Purpose: The study will examine
whether Minocycline treatment for 24 weeks improves HIV-associate
cognitive impairment
Drug(s) Provided by the Study:
Minocycline 100 mg and Placebo followed by open label Minocycline
Clinician Summary Sheet - Word
Participant Summary Sheet_Word
Advertisement Flyer- Word
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Hepatitis
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WU
210 Functional Neuroimaging of Cognitive
Dysfuntion in HIV-HCV Co-Infection |
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Hepatitis C |
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ACTG 5232:
immune defects in people with Hepatitis C |
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Hepatitis
B
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ACTG 5232:
Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by
Identifying Determinants of Responsiveness: A Pilot Study
Brief Description/ Purpose of this Study:
A5232 is a pilot study investigating the extent of immune defects in
people who have Hepatitis C, HIV, or both. This will be done by immunizing
people with antibodies to both tetanus toxoid and hepatitis A and B, and
evaluating immunological response.
Treatment: .Participants in each arm
will be immunized with diphtheria/tetanus toxoid on day 0, and with
combined hepatitis A-hepatitis B vaccine (Twinrix: recombinant HBV at 20
μg, HAV at 720 ELU, and aluminum at 0.45 mg) on days 0, 7, and 21
(accelerated vaccination protocol).
Summary
WU
210 Functional Neuroimaging of Cognitive Dysfuntion in
HIV-HCV Co-Infection
Purpose: Dr. Clifford and his
associates are conducting this research study to learn more about the
effects of infection with human immunodeficiency virus (HIV) on the brain.
Some people infected with HIV and hepatitis C virus (HCV) experience
problems thinking quickly, remembering new information, and other forms of
thinking difficulties. These difficulties may reflect differences in how
the brain is functioning, and this can be visualized using a Magnetic
Resonance Imaging (MRI) scanner that provides pictures of the brain. The
purpose of this study is to learn whether people infected with both HIV
and HCV experience more difficulties thinking compared to people infected
with just HIV. We also are interested in learning if individuals with both
infections show any differences in brain function when completing tests of
thinking inside the scanner.
Drugs Provided by the Study: None;
Everyone enrolled in the study will complete a Neuropsychological
Assessments and Blood Draw. Only half of the study participants will
complete an MRI. If an MRI is not desired, otherwise eligible persons may
still take part in the study.
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Prevention of Complications
No studies listed at this time.
Immunology
No studies at this time.
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SPECIAL
TRIALS FOR WOMEN
Currently all of our studies are open to women, some of which include
"smaller" studies that look at women specific issues.
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WU 204: comparing prezista/r by gender and
race |
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A5227:
Effect of short course treatment to prevent mother-to-child
transmission of HIV on subsequent treatment efficacy |
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ACTG 5240:
Immunogenicity & Safety of a
Quadrivalent HPV Vaccine in HIV-1-Infected Females |
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For
Women
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ACTG 5240:
Immunogenicity & Safety of a Quadrivalent HPV Vaccine in HIV-1-Infected
Females
Brief Description: Human
papillomavirus (HPV) is the most common sexually transmitted disease in
the United States and worldwide. There are over 90 types of HPV that
infect humans. Some of these types infect the genital and anal areas where
the infection causes genital and anal warts. It also causes cancer of the
cervix (the opening of the uterus) in females. HPV infection may be more
severe and harder to treat in people infected with HIV. The FDA has
approved an HPV vaccine (called Gardasil), and it is directed against 4
types of HPV which are the most common causes of genital warts and
cervical cancer. This study is the first of its kind to test the HPV
vaccine in females infected with HIV.
Treatment: Study treatment is defined
as quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine, Gardasil,
and will be provided to you by the study. Quadrivalent means that the
vaccine is directed at four types of HPV. If you are currently taking
antiretroviral drugs, you should continue taking them unless your doctor
tells you otherwise. Your antiretroviral drugs will not be provided to you
by the study. You must get them through your primary care provider.
Participant
Summary
WU 204:
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: 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
(adverse events) 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
ACTG
5227:
The Effect of Prior Short Course Combination Antiretroviral Therapy
Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of
HIV-1 on Subsequent Treatment Efficacy in Treatment-“Nearly Naïve”
Participants
Purpose: The purpose of this study is
to see if women who have been treated with anti-HIV drugs during pregnancy
can be treated like people who have never received anti-HIV drugs.
Drug(s) Provided by the Study:
Efavirenz and Truvada
Participant
Summary Sheet
Clinician Summary
sheet
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OTHER
CATEGORY
WU 190:
The Effects of HIV and
Highly Active Antiretroviral Therapy in an Aging Outpatient Population
Drug(s)
Provided by the Study:
None. Includes brief
cognitive testing, laboratory testing, and DEXA. Participants will be
followed for one year.
WU
209: A case-control toxicogenomics study to identify unique
genetic polymorphism in patients who have experienced symptomatic
hepatotoxicity or severe cutaneous toxicity within the first 8 weeks of
nevirapine therapy
Purpose: To determine whether there
are genes that protect a patient from the side effects of severe liver
damage or severe skin rash or whether there are genes that allow these
side effects to occur.
Drugs(s) Provided by the Study: None
Division of Infectious Diseases
Department of Medicine
Washington University School of Medicine
This page was last updated on
06/13/2008
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