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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00028314 |
The goals of this study are to find out if fat wasting and weight loss in the arms and legs of HIV patients taking highly active antiretroviral therapy (HAART) are caused by nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and if wasting can be reversed if the NRTI is stopped and replaced with other anti-HIV drugs.
Condition | Intervention |
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HIV Infections Lipodystrophy Wasting Disease |
Drug: Abacavir sulfate Drug: Atazanavir/Ritonavir Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 150 |
Recent studies suggest body shape changes, fat redistribution, and fat lipoatrophy may be related to the NRTI component of patients' HAART and not to the protease inhibitor (PI) component. The hypothesis of this study is that thymidine analogues such as stavudine (d4T) and zidovudine (ZDV) cause lipoatrophy more so than non-thymidine analogues and that removal of thymidine analogues from HAART in patients with defined lipoatrophy will reverse this process.
In Step 1, patients will undergo axial mid-thigh and abdomen computer tomography (CT) scans. If the CT scans are readable, patients are restrictively and randomly assigned to 1 of 2 treatment arms in Step 2. Patients in Arm A-1 will replace the thymidine analogue component (stavudine [d4T] or zidovudine [ZDV]) of their HAART with abacavir (ABC). Patients in Arm B-1 will discontinue their current HAART and will receive a PI and a nonnucleoside reverse transcriptase inhibitor (NNRTI), either lopinavir/ritonavir (LPV/r) and nevirapine (NVP) or atazanavir, ritonavir, and NVP. Patients currently on efavirenz (EFV) not provided by the study may choose to continue with EFV instead of switching to NVP. Comparisons will be made to the baseline values of subcutaneous fat measured by mid-thigh and abdominal CT. Patients in Arms A-1 and B-1 remain on study for a total of 48 weeks and do not advance to Step 3.
Two additional groups (Arms A-2 and B-2) made no changes to HAART for 28 weeks to evaluate the natural history of change in lipoatrophy over time; accrual into these groups and into Step 3 has been discontinued. At Week 28, patients in Arms A-2 and B-2 were registered to Step 3 and switched from HAART to a designated new treatment. Arm A-2 patients will replace d4T or ZDV with ABC for 48 weeks. Arm B-2 patients replace their HAART with LPV/r plus NVP for 48 weeks. If patients in Arms A-2 and B-2 have not completed the 28-week delay and have not switched regimens, they will enter Step 4 and be reregistered into Arms A-1 and B-1, respectively, remaining on their treatment assignment for 48 weeks. If patients in Arms A-2 and B-2 have already switched regimens, then they will continue on their new regimens until Week 76.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Note: accrual into Arms A-2 and B-2 of this study has been discontinued.
Inclusion Criteria for Step 1
Exclusion Criteria for Step 1
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
Harbor General / UCLA | |
Torrance, California, United States, 90502-2052 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
The CORE Ctr | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455-0392 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St Louis, Missouri, United States, 63108 | |
Washington Univ / St Louis Connect Care | |
Saint Louis, Missouri, United States, 63108 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, Ohio | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 44109-1998 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0405 | |
United States, Pennsylvania | |
Univ of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Miriam Hosp / Family Healthcare Ctr at SSTAR | |
Providence, Rhode Island, United States, 02906 | |
Miriam Hosp / Brown Univ | |
Providence, Rhode Island, United States, 02906 | |
Brown Univ / Miriam Hosp | |
Providence, Rhode Island, United States, 02906 | |
United States, Tennessee | |
Comprehensive Care Clinic | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Univ of Texas Galveston | |
Galveston, Texas, United States, 775550435 |
Study Chair: | Robert L Murphy, MD | Northwestern University Medical Center |
Study Chair: | Pablo Tebas, MD | University of Pennsylvania, Adult Clinical Trials Unit |
Study ID Numbers: | ACTG A5110, AACTG A5110 |
Study First Received: | December 20, 2001 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00028314 |
Health Authority: | United States: Federal Government |
HIV-1 Abacavir Nevirapine Ritonavir RNA, Viral HIV Protease Inhibitors |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load HIV Wasting Syndrome ABT 378 Treatment Experienced |
Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Atazanavir Immunologic Deficiency Syndromes Virus Diseases Nevirapine Lopinavir |
Ritonavir HIV Infections Lipodystrophy Sexually Transmitted Diseases Nutrition Disorders Abacavir Metabolic disorder Wasting Syndrome Retroviridae Infections Lipid Metabolism Disorders |
Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Skin Diseases, Metabolic Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |