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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 is a Phase 4 study that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 17 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00960622
The ClinicalTrials.gov registry entry for NCT00960622 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Luke's-Roosevelt Hospital Center, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Truvada is the first listed.
NCT00960622 reports 0 study locations.
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.
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