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Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects

NCT00960622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-03-04

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • St. Luke's-Roosevelt Hospital Center

    lead OTHER

Principal Investigators

  • Donald P Kotler, MD · St Luke's Roosevelt Hospital New York City

  • Gabriel Ionescu, MD · SLRHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960622 on ClinicalTrials.gov