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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
stavudine extended-release, lamivudine, efavirenz
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

Efficacy at week 48

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2005
Last Updated
April 8, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00135369
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
stavudine extended-release, lamivudine, efavirenz
Primary Outcome Measure Information:
Title
Efficacy at week 48
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Local Institution
City
Hobson City
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Montgomery
State/Province
Alabama
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United States
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Local Institution
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Phoenix
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Los Angeles
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California
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United States
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Local Institution
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Sacramento
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California
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United States
Facility Name
Local Institution
City
San Mateo
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California
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United States
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Torrance
State/Province
California
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United States
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Denver
State/Province
Colorado
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United States
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Norwalk
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Connecticut
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United States
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Local Institution
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Stratford
State/Province
Connecticut
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United States
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Washington
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District of Columbia
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United States
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Ft. Lauderdale
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Florida
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United States
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Miami Beach
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Florida
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United States
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Miami
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Florida
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United States
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Pensacola
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Florida
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United States
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Tampa
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Florida
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United States
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Decatur
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Georgia
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United States
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Chicago
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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New Orleans
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Louisiana
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United States
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Baltimore
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Maryland
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United States
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Boston
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Massachusetts
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United States
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Berkley
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Michigan
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United States
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Detroit
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Michigan
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United States
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St. Louis
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Missouri
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United States
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Las Vegas
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Nevada
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United States
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Hackensack
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New Jersey
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United States
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Jersey City
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New Jersey
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United States
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Neptune
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New Jersey
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United States
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Somers Point
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New Jersey
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United States
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Bronx
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New York
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United States
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Manhasset
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New York
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United States
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New York
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New York
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United States
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Charlotte
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North Carolina
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United States
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Huntersville
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North Carolina
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United States
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Washington
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North Carolina
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United States
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Winston-Salem
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North Carolina
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United States
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Philadelphia
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Pennsylvania
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United States
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Reading
State/Province
Pennsylvania
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United States
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Dallas
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Texas
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United States
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Galveston
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Texas
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United States
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Houston
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Texas
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United States
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Annandale
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Virginia
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United States
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Hampton
State/Province
Virginia
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United States
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Seattle
State/Province
Washington
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United States
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Local Institution
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San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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