At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy
In Brief
A Phase 4 clinical trial evaluating Truvada, Combivir, and 1 other intervention for HIV. Completed, enrolled 17 participants across 1 site.
Detailed Summary
Study subjects receiving the antiretroviral drugs Combivir or trizivir, will be randomized to switch to Truvada-containing highly active antiretroviral therapy (HAART) or to continue on Combivir or on trizivir. Measurements will be performed at baseline and after 6 months after randomization to either continuing on trizivir or combivir, or to switching to Truvada. Measurements include maximal or peak oxygen consumption, 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 Details
Timeline
Interventions
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)