Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

April 8, 2011 updated by: Bristol-Myers Squibb

A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

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
      • San Juan, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Hobson City, Alabama, United States
        • Local Institution
      • Montgomery, Alabama, United States
        • Local Institution
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Los Angeles, California, United States
        • Local Institution
      • Sacramento, California, United States
        • Local Institution
      • San Mateo, California, United States
        • Local Institution
      • Torrance, California, United States
        • Local Institution
    • Colorado
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Norwalk, Connecticut, United States
        • Local Institution
      • Stratford, Connecticut, United States
        • Local Institution
    • District of Columbia
      • Washington, District of Columbia, United States
        • Local Institution
    • Florida
      • Ft. Lauderdale, Florida, United States
        • Local Institution
      • Miami, Florida, United States
        • Local Institution
      • Miami Beach, Florida, United States
        • Local Institution
      • Pensacola, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
    • Georgia
      • Decatur, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Michigan
      • Berkley, Michigan, United States
        • Local Institution
      • Detroit, Michigan, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • Nevada
      • Las Vegas, Nevada, United States
        • Local Institution
    • New Jersey
      • Hackensack, New Jersey, United States
        • Local Institution
      • Jersey City, New Jersey, United States
        • Local Institution
      • Neptune, New Jersey, United States
        • Local Institution
      • Somers Point, New Jersey, United States
        • Local Institution
    • New York
      • Bronx, New York, United States
        • Local Institution
      • Manhasset, New York, United States
        • Local Institution
      • New York, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
      • Huntersville, North Carolina, United States
        • Local Institution
      • Washington, North Carolina, United States
        • Local Institution
      • Winston-Salem, North Carolina, United States
        • Local Institution
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Reading, Pennsylvania, United States
        • Local Institution
    • Texas
      • Dallas, Texas, United States
        • Local Institution
      • Galveston, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
    • Virginia
      • Annandale, Virginia, United States
        • Local Institution
      • Hampton, Virginia, United States
        • Local Institution
    • Washington
      • Seattle, Washington, 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

16 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 or older and weigh at least 40 kg
  • Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
  • Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Exclusion Criteria:

  • Pregnancy, breastfeeding or plans to become pregnant during the study period
  • Any prior documented virologic failure to one or more HAART regimens
  • 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

September 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 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)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 8, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI455-135

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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