Switch From Combivir to Truvada - Mitochondrial Effects
Summary
Study subjects receiving the antiretroviral (anti-HIV) Combivir will be randomized to switch to Truvada-containing HAART or continue on Combivir. Measurements before and after 6 months will include maximal oxygen consumption and exercise tolerance, lactate production and clearance, subcutaneous adipose tissue and limb fat contents, insulin resistance, liver and muscle fat contents, and plasma free fatty acid concentrations. The hypothesis underlying this study is that chronic therapy with thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), including zidovudine (AZT), leads to clinically detectable mitochondrial dysfunction in several organ systems.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
HIV
Intervention
Truvada vs Combivir
Location
St. Luke's-Roosevelt Hospital Center
New York
New York
United States
10025
Status
Completed
Source
St. Luke's-Roosevelt Hospital Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00960622
- Information obtained from ClinicalTrials.gov on July 15, 2010
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