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NCT00135356 · ClinicalTrials.gov registry record · Phase 4
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
A Phase 4 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 219
- Enrollment target
NCT00135356: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT00135356 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 219 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135356, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 219 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.
Primary Outcome
Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
Interventions
- DRUG Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)
- DRUG continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2005-07 |
| Est. Completion | 2008-06 |
| Phase | Phase 4 |
What the finished NCT00135356 record still lists
NCT00135356 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) is the first listed.
NCT00135356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00135356 about?
NCT00135356 is a clinical study titled "Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome". The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those r...
What is the current status of trial NCT00135356?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 219 participants. The study started on 2005-07. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00135356?
The interventions under investigation include: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) (DRUG), continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) (DRUG).
Who is sponsoring clinical trial NCT00135356?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135356's enrollment target sits among peer trials
219 389th of 2000 higher than 1,611 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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