Interim Results Studies that are in progress and reached study interim monitoring review

Below is a posting of results of studies conducted at our site or among sites of the AIDS Clinical Trials Group. This information is intended for Patients, Families, the Public and Health Care Providers. The listing includes study results published since April 2003.  J Am Coll Cardiol. 2008 Aug 12;52(7):569-76.  Endothelial function in human immunodeficiency virus-infected antiretroviral-naive subjects before and after starting potent antiretroviral therapy: The ACTG (AIDS Clinical Trials Group) Study 5152s. Torriani FJ, Komarow L, Parker RA, Cotter BR, Currier JS, Dubé MP, Fichtenbaum CJ, Gerschenson M, Mitchell CK, Murphy RL, Squires K, Stein JH; ACTG 5152s Study Team. Objectives: This study evaluated the effects of 3 class-sparing antiretroviral therapy (ART) regimens on endothelial function in human immunodeficiency virus (HIV)-infected subjects participating in a randomized trial. BACKGROUND: Endothelial dysfunction has been observed in patients receiving ART for HIV infection. METHODS: This was a prospective, multicenter study of treatment-naive subjects who were randomly assigned to receive a protease inhibitor-sparing regimen of nucleoside reverse transcriptase inhibitors (NRTIs) + efavirenz, a non-nucleoside reverse transcriptase inhibitor-sparing regimen of NRTIs + lopinavir/ritonavir, or a NRTI-sparing regimen of efavirenz + lopinavir/ritonavir. The NRTIs were lamivudine + stavudine, zidovudine, or tenofovir. Brachial artery flow-mediated dilation (FMD) was determined by B-mode ultrasound before starting on ART, then after 4 and 24 weeks. RESULTS: There were 82 subjects (median age 35 years, 91% men, 54% white). Baseline CD4 cell counts and plasma HIV ribonucleic acid (RNA) values were 245 cells/mm(3) and 4.8 log(10) copies/ml, respectively. At baseline, FMD was 3.68% (interquartile range [IQR] 1.98% to 5.51%). After 4 and 24 weeks of ART, plasma HIV RNA decreased by 2.1 and 3.0 log(10) copies/ml, respectively. FMD increased by 0.74% (IQR -0.62% to +2.74%, p = 0.003) and 1.48% (IQR -0.20% to +4.30%, p < 0.001), respectively, with similar changes in each arm (Kruskal-Wallis p value >0.600). The decrease in plasma HIV RNA at 24 weeks was associated with greater FMD (r(s) = -0.30, p = 0.017). CONCLUSIONS: Among treatment-naive individuals with HIV, 3 different ART regimens rapidly improved endothelial function. Benefits were similar for all ART regimens, appeared quickly, and persisted at 24 weeks. PMID: 18687253 [PubMed - in process]   10/15/06 Immunogenetics of CD4 Lymphocyte Count Recovery during Antiretroviral Therapy:An AIDS Clinical Trials Group Study (ALLRT A5001) Full Article 10/15/06 Cyclosporin A Provides No Sustained Immunologic Benefit to Persons with Chronic HIV-1 Infection Starting Suppressive Antiretroviral Therapy:Results of a Randomized, Controlled Trial of the AIDS Clinical Trials Group A5138 Full Article 8/16/06 Treatment for Adult HIV Infection 2006 Recommendations of the International AIDS Society–USA Panel ACTG 5095 Abstract    Full Article 4/24/2006 The SMART Trial: Episodic CD4-Guided Use of ART Is Inferior to Continuous Therapy: Results of the SMART Study abstract  Full Article 3/3/2006 ACTG 5079, Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for Men with Mild to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity results 2/3/2006 ACTG 5030, Valganciclovir Pre-emptive Therapy for CMV Viremia as Detected by Plasma CMV DNA PCR Assay; This study was done to find out whether giving the medication valganciclovir to people at risk for getting CMV disease will help prevent them from getting that disease. preliminary executive summary 2/17/2006 ACTG 5170, “Predictors of HIV Disease Progression in Patients Who Stop Antiretroviral Therapy with CD4 Cell Counts >350 cells/mm3.” results 2/17/2006 ACTG 5138, “Augmenting the Magnitude of HAART-Induced Immune Restoration by the Use of Cyclosporine.” results 2/17/2006 ACTG 5170, “Predictors of HIV Disease Progression in Patients Who Stop Antiretroviral Therapy with CD4 Cell Counts >350 cells/mm3 results 2/17/2006 ACTG A5186, A Phase II Trial of the Effect of Combination Therapy with Fish Oil Supplement and Fenofibrate on Triglyceride (TG) Levels in Subjects on Highly Active Antiretroviral Therapy (HAART) Who Are Not Responding to Either Fish Oil or Fenofibrate Alone executive summary   12-15-2005 A5095, Version 2.0, 01/31/02 entitled “Phase III, Randomized, Double-Blind Comparison of Three Protease-Inhibitor-Sparing Regimens for the Initial Treatment of HIV Infection” final results 3-15-2005 Treating Opportunistic Infections among HIV-Infected Adults and Adolescents: Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America - Abstract 2-18-2005 Serum Neopterin, an Immune Activation Marker, Independently Predicts Disease Progression in Advanced HIV-1 Infection - Article 2-1-2005 Pilot Study of Low-Dose Interleukin-2, Pegylated Interferon2b, and Ribavirin for the Treatment of Hepatitis C Virus Infection in Patients with HIV Infection - A5088 Results Published 7-28-2004 Press Release: Researchers Identify Better Hepatitis C Treatment for People with HIV. A5071 Results Published in The NEJM 4-29-2004 Triple-Nucleoside Regimens versus Efavirenz-Containing Regimens for the Initial Treatment of HIV-1 Infection - A5095 Results Published or Interim Results 1-2-2004 Combination, order of anti-HIV drugs make a difference in first-time recipients - ACTG 384 Protocol Results HIV Lipodystrophy Case Definition (WashU 83) As a result of this study, there is now a standardized and objective definition of liposdystrophy in HIV-infected adults that can be applied to both clinical studies as well as routine patient care. Results of the study, including a rapid method for individuals to determine whether an HIV-infected adult is affected by lipodystrophy, are available at the following website: http:///www.med.unsw.edu.au/nchecr Interim Results from a Phase III, Randomized, double-Blind Camparison of Three Prrotease-Inhibitor-Sparing Regimens for the Intitial Treatment of HIV Infection (ACTG 5095) Letter to Health Care Providers from the Department of Health & Human Services - Interim Results Results from  (WU 47) Mechanisms for Metabolic Complications in HIV Visceral adiposity, C-peptide levels, and low lipase activities predict HIV dislipidemia. The article can be found at the following website: http://ajpendo.physiology.org/cgi/reprint/00036.2003v1.pdf Interim Results from (WU 89) Muscle Lipid Metabolism in Highly Active Retroviral Therapy Alterations in lipid kinetics in men with HIV-dislipidemia. The article can be found at the following website: http://ajpendo.physiology.org/cgi/reprint/00118.2003v1.pdf A5071 The Association of Hepatitis C Virus (HCV)-specific Immune Responses With Liver Histology and Treatment Outcomes in Persons With HIV/HCV Co-infection Abstract  A5047 Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers. Abstract   Interim Results for Ongoing Studies 2/17/2006 ACTG 5015, “A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Patients to Explore the Basis of Accelerated HIV-Disease Progression Associated with Aging” and substudies A5016s, “Core Immunology Substudy” and A5020s, “Genital Secretions Substudy.” preliminary results 2/17/2006 ACTG 5084, , “Evaluation of Metabolic Complications Associated with Antiretroviral Medications in HIV-1-infected Pregnant Women.” preliminary results 2/17/2006 ACTG A736, “Ceribrospinal fluid human immunodeficincy virus -1 (HIV-1) and cognitive function in individuals receiving potent antiretroviral". preliminary findings Protocol 5068: 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 Primary Analysis Summary Protocol A5110 "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”, a multicenter clinical trial supported by the National Institute of Allergy and Infectious Diseases, NIH, through the AACTG. The team medical officer and an interim monitoring group have reviewed the interim safety data from this trial. Summary ACTG A5116 A Randomized, Controlled Trial of Two Potent, Simplified Regimens: Protease Inhibitor-Sparing vs Nucleoside-Sparing Regimen for HIV-Infected Subjects Who Participated in ACTG 388 or Who Responded to a First Potent Combination Regimen and Have < 200 HIV-1 RNA Copies/ML Summary Division of Infectious Diseases Department of Medicine Washington University School of Medicine