Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

Completed

• Conditions: HIV Infections

• Registration Number: NCT00433992
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Results First Submitted: 2017-03-28
• Results First Submitted QC: 2017-06-16
• Results First Posted: 2017-07-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Mitochondrial Activity	Entry, Week 96	mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.

Secondary Outcome Measures

Name	Time	Method
Change in Fat Apoptosis	Entry, Week 48	Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry

Trial Locations

Locations (1)

Case School of Medicine; 🇺🇸 Cleveland, Ohio, United States