NCT00960622

Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: St. Luke's-Roosevelt Hospital Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

None different from the summary description above.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Truvada	Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
DRUG	Combivir	Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
DRUG	Trizivir	Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-08-18
• Last updated: 2013-03-04
• Results posted: 2013-03-04

Locations

1 site across 1 country: United States