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NCT00960622 · ClinicalTrials.gov registry record · Phase 4
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
A Phase 4 study, sponsored by St. Luke's-Roosevelt Hospital Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT00960622: Completed Phase 4 study, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT00960622 is a Phase 4 study that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00960622, a Phase 4 study, has completed, sponsored by St. Luke's-Roosevelt Hospital Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Truvada
- DRUG Combivir
- DRUG Trizivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-08 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00960622 record still lists
NCT00960622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Truvada is the first listed.
NCT00960622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00960622 about?
NCT00960622 is a clinical study titled "Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects". 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 eith...
What is the current status of trial NCT00960622?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2006-08. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00960622?
The interventions under investigation include: Truvada (DRUG), Combivir (DRUG), Trizivir (DRUG).
Who is sponsoring clinical trial NCT00960622?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00960622's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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