Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Truvada; Drug: Combivir; Drug: Trizivir

• Registration Number: NCT00960622
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief 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.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Results First Submitted: 2011-09-21
• Status Verified: 2012-09
• Results First Submitted QC: 2013-01-25
• Last Update Submitted: 2013-01-25
• Results First Posted: 2013-03-04
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• infection with human immunodeficiency virus (HIV) with undetectable viral load
• on Combivir or trizivir
• able to exercise and sign consent

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Exclusion Criteria

• other active illness
• contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Peak Oxygen Uptake.	baseline and 6 months	change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups.

Trial Locations

Locations (1)

St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States