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Completed

NCT Number: NCT00960622

Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Luke's-Roosevelt Hospital Center

New York, 10025, United States

About this study

None different from the summary description above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Truvada

Drug

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

Other names: emtricitabine and tenofovir disoproxil fumarate

Combivir

Drug

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

Other names: Retrovir, zidovudine, Epivir, lamivudine

Trizivir

Drug

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

Other names: abacavir, abacavir sulfate, lamivudine, zidovudine

Primary outcomes

  1. Change in Peak Oxygen Uptake.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: TRU

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 18, 2009
Registry last updated
Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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