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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135382
The ClinicalTrials.gov registry entry for NCT00135382 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (43% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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