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NCT00135382 · ClinicalTrials.gov registry record · Phase 3
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
A Phase 3 study of HIV Infections, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
- 20
- Study locations
NCT00135382: Completed Phase 3 study of HIV Infections, sponsored by Bristol-Myers Squibb.
NCT00135382 is a Phase 3 study of HIV Infections that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 254 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135382, a Phase 3 study of HIV Infections, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
Conditions Studied
Interventions
- DRUG Videx EC
- DRUG Epivir
- DRUG Sustiva
Study Locations (20)
California
- Local Institution - Beverly Hills
- Local Institution - Fountain Valley
- Local Institution - Long Beach
- Local Institution - Los Angeles
- Local Institution - San Diego
- Local Institution - San Francisco
- Local Institution - Tarzana
- Local Institution - West Hollywood
Florida
- Local Institution - Atlantis
- Local Institution - Daytona Beach
- Local Institution - Fort Lauderdale
- Local Institution - Jacksonville
- Local Institution - Miami
- Local Institution - Miami Beach
- Local Institution - North Miami
- Local Institution - Orlando
Arkansas
- Local Institution - Little Rock
Colorado
- Local Institution - Denver
Connecticut
- Local Institution - Norwalk
District of Columbia
- Local Institution - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2002-06 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00135382 record still lists
NCT00135382 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (43% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Videx EC is the first listed.
NCT00135382 names 20 study sites across 6 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00135382 about?
NCT00135382 is a clinical study titled "Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen". The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have p...
What is the current status of trial NCT00135382?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2002-06. Estimated completion is 2005-10.
What conditions does trial NCT00135382 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00135382?
The interventions under investigation include: Videx EC (DRUG), Epivir (DRUG), Sustiva (DRUG).
Who is sponsoring clinical trial NCT00135382?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00135382 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00135382's enrollment target sits among peer trials
254 138th of 542 higher than 405 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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