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

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ClinicalTrials.gov Identifier: NCT00960622
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug: Truvada Drug: Combivir Drug: Trizivir Phase 4

Detailed Description:
None different from the summary description above.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Truvada
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
 Drug: Truvada
Truvada (tenofovir 300mg / emtricitabine 200mg) capsule once daily for 6 months
Other Name: emtricitabine and tenofovir disoproxil fumarate
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)
 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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960622


Locations
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Gilead Sciences
Investigators
Principal Investigator: Donald P Kotler, MD St Luke's Roosevelt Hospital New York City
Principal Investigator: Gabriel Ionescu, MD SLRHC
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00960622     History of Changes
Other Study ID Numbers: TRU
First Posted: August 18, 2009    Key Record Dates
Results First Posted: March 4, 2013
Last Update Posted: March 4, 2013
Last Verified: September 2012

Keywords provided by St. Luke's-Roosevelt Hospital Center:
treatment experienced

Additional relevant MeSH terms:
Tenofovir
Lamivudine
Emtricitabine
Zidovudine
Abacavir
Dideoxynucleosides
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine, zidovudine drug combination
Antiviral Agents
 Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimetabolites