Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

Completed · Phase 4

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT00960622

Run by

St. Luke's-Roosevelt Hospital Center

People needed

17

Starts

2006-08-01

Expected to finish

2009-07-01

Last updated by the study team

2013-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• St. Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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