Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

January 27, 2010 updated by: Bristol-Myers Squibb

A 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Study Type

Interventional

Enrollment

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico
        • Local Institution
      • Rio Piedras, Puerto Rico
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • Fountain Valley, California, United States
        • Local Institution
      • Long Beach, California, United States
        • Local Institution
      • Los Angeles, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • San Francisco, California, United States
        • Local Institution
      • Tarzana, California, United States
        • Local Institution
      • W. Hollywood, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Norwalk, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Atlantis, Florida, United States
        • Local Institution
      • Daytona Beach, Florida, United States
        • Local Institution
      • Ft. Lauderdale, Florida, United States
        • Local Institution
      • Jacksonville, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • Miami Beach, Florida, United States
        • Local Institution
      • North Miami, Florida, United States
        • Local Institution
      • Orlando, Florida, United States
        • Local Institution
      • Plantation, Florida, United States
        • Local Institution
      • Safety Harbor, Florida, United States
        • Local Institution
      • South Miami, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Decatur, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
      • Springfield, Massachusetts, United States
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States
        • Local Institution
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • East Orange, New Jersey, United States
        • Local Institution
      • Newark, New Jersey, United States
        • Local Institution
      • Union, New Jersey, United States
        • Local Institution
    • New York
      • Brooklyn, New York, United States
        • Local Institution
      • Manhasset, New York, United States
        • Local Institution
      • Mt. Vernon, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
      • Stony Brook, New York, United States
        • Local Institution
      • Valhalla, New York, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
    • Virginia
      • Hampton, Virginia, United States
        • Local Institution
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented HIV infection
  • ≥ 18 years of age and weight at least 40kg
  • Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
  • Patients receiving a PI and ≥ 2 NRTIs

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
  • Active AIDS-defining opportunistic infection or disease
  • Proven or suspected acute hepatitis within 30 days prior to study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy at week 48

Secondary Outcome Measures

Outcome Measure
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 25, 2005

First Submitted That Met QC Criteria

August 25, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

January 27, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI266-406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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