CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Truvada +2 moredrug
Likely dose
Truvada 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00960622
NCT00960622Phase 4Completed

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

St. Luke's-Roosevelt Hospital Center·interventional·Posted Aug 18, 2009·Updated Mar 4, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2009
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.9 years ago

Interventions

Truvadadrug

Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months

Combivirdrug

Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months

Trizivirdrug

Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)