Phase 4
N=20
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
HIV
Bottom Line
View on ClinicalTrials.gov: NCT00960622 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Change in Peak Oxygen Uptake. — 2.2; 2.8 ml/Kg/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Truvada (Drug); Combivir (Drug); Trizivir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Oxygen Uptake. |
2.2; 2.8 | <0.05 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00960622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.