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

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:
Drug: Trizivir
Continue on Trizivir (300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine)
Other Names:
|
- 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.

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

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
United States, New York | |
St. Luke's-Roosevelt Hospital Center | |
New York, New York, United States, 10025 |
Principal Investigator: | Donald P Kotler, MD | St Luke's Roosevelt Hospital New York City | |
Principal Investigator: | Gabriel Ionescu, MD | SLRHC |
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 |