Effects of Treatment Changes on Fat Wasting in the Arms and Legs of HIV Patients
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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 |
---|---|
HIV Infections Lipodystrophy Wasting Disease |
Drug: Abacavir sulfate Drug: Atazanavir/Ritonavir Drug: Lopinavir/Ritonavir Drug: Nevirapine |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
Study Start Date: | March 2002 |
Study Completion Date: | March 2005 |
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.
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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
- HIV infected
- Experiencing a loss of fat since starting anti-HIV therapy, especially in the arms and legs
- Receiving anti-HIV therapy of 3 or more drugs, including either stavudine or zidovudine, for 24 weeks or more prior to study screening
- Viral load less than 500 copies/ml at study screening and within 60 days prior to study entry
- CD4 count of 100 or more cells/mm3 obtained within 60 days prior to study entry
- Approved methods of contraception
- Written informed consent
Exclusion Criteria for Step 1
- Currently receiving abacavir sulfate or have received abacavir sulfate in the past AND any or all of the following: unable to tolerate lopinavir/ritonavir (LPV/r) or nevirapine (NVP); failed anti-HIV treatment containing LPV/r, any other 2 PIs, or any other NNRTI; taking lamivudine (3TC) or tenofovir disoproxil fumarate (TDF) for hepatitis B virus infection and need to remain on a 3TC- or TDF-containing regimen; or have a low chance of response to LPV/r plus NVP
- Cancer treatment 6 months prior to study entry
- Initiated oral drugs to lower blood sugar level 24 weeks prior to study entry. Patients who have taken oral drugs to lower their blood sugar levels for 24 weeks or more prior to study entry are eligible.
- Began therapy with male sex hormones 24 weeks prior to study entry. Patients who have had continuous, stable therapy with male sex hormones for 24 weeks or more prior to study entry are eligible.
- Certain medications within 14 days prior to study entry
- Serious illness within 14 days prior to study entry
- Hepatitis within 60 days prior to study entry
- Thyroid problems
- Drug or alcohol use which, in the opinion of the investigator, would interfere with the study
- Currently using experimental agents except when approved by the study
- Pregnant or breastfeeding
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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 / St Louis Connect Care | |
Saint Louis, Missouri, United States, 63108 | |
Washington Univ School of Medicine | |
St 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 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0405 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 44109-1998 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
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 |
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Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00028314 History of Changes |
Other Study ID Numbers: | A5110, AACTG A5110, ACTG A5110 |
Study First Received: | December 20, 2001 |
Last Updated: | October 25, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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 |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic Skin Diseases |
Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nevirapine Ritonavir Abacavir Lopinavir Atazanavir Reverse Transcriptase Inhibitors HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 07, 2013