Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

Study Overview
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Brief Summary
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The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.

Detailed Description
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The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens. This study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens. This study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.

Official Title
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Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infected Enrolling in ACTG A5202 and its metabolic substudy ACTG A5224 Exclusion Criteria: Bleeding problems Cannot undergo fat biopsies Require aspirin anytime in the 7-day period prior to each biopsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ABC/3TC<br>HIV-infected subjects were given Abacavir-Lamuvidine | |
| TDF/FTC<br>HIV-infected patients were given tenofovir DF-emtricitabine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mitochondrial Activity | mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction. | Entry, Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Apoptosis | Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry | Entry, Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitochondria, Fat apoptosis, Lipoatrophy, Lipodystrophy, Thymidine, Treatment experienced