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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.

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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

FieldValue
Enrollment Target 254 participants
Start Date 2002-06
Est. Completion 2005-10
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.