Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects (TRU)

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00960622
First received: August 17, 2009
Last updated: January 25, 2013
Last verified: September 2012

August 17, 2009
January 25, 2013
August 2006
July 2009   (final data collection date for primary outcome measure)
Change in Peak Oxygen Uptake. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
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.
VO2 max [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00960622 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
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

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.

None different from the summary description above.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • Drug: Truvada
    Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
    Other Name: emtricitabine and tenofovir disoproxil fumarate
  • Drug: Combivir
    Continue on Combivir (150 mg of lamivudine, 300 mg of zidovudine) two tablets daily for 6 months
    Other Names:
    • Retrovir
    • zidovudine
    • Epivir
    • lamivudine
  • Drug: Trizivir
    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
  • Experimental: Truvada
    Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
    Intervention: Drug: Truvada
  • Active Comparator: Combivir or 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)
    Interventions:
    • Drug: Combivir
    • Drug: Trizivir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00960622
TRU
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Gilead Sciences
Principal Investigator: Donald P Kotler, MD St Luke's Roosevelt Hospital New York City
Principal Investigator: Gabriel Ionescu, MD SLRHC
St. Luke's-Roosevelt Hospital Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP