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
  Purpose

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 Intervention Phase
HIV
Drug: Truvada
Drug: Combivir
Drug: Trizivir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • 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.


Enrollment: 17
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

None different from the summary description above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00960622     History of Changes
Other Study ID Numbers: TRU
Study First Received: August 17, 2009
Results First Received: September 21, 2011
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Lamivudine
Zidovudine
Abacavir
Lamivudine, zidovudine drug combination
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 18, 2014