Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

Study Overview
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Brief Summary
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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
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None different from the summary description above.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: Truvada
* Drug: Combivir
* Drug: Trizivir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infection with human immunodeficiency virus (HIV) with undetectable viral load on Combivir or trizivir able to exercise and sign consent Exclusion Criteria: other active illness contraindication to magnetic resonance imaging (MRI) scanning or maximal exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Truvada<br>Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months | Drug: Truvada<br>* Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months<br>* Other names: emtricitabine and tenofovir disoproxil fumarate;|
| Active Comparator: Combivir or Trizivir<br>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) | Drug: Combivir<br>* Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months<br>* Other names: lamivudine;Drug: Trizivir<br>* Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)<br>* Other names: zidovudine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peak Oxygen Uptake. | 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. | baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment experienced