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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Videx EC
Epivir
Sustiva
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 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

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
January 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00135382
Brief Title
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 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 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.
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.

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
254 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Videx EC
Intervention Type
Drug
Intervention Name(s)
Epivir
Intervention Type
Drug
Intervention Name(s)
Sustiva
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 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
Facility Information:
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
Beverly Hills
State/Province
California
Country
United States
Facility Name
Local Institution
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Local Institution
City
Long Beach
State/Province
California
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
Tarzana
State/Province
California
Country
United States
Facility Name
Local Institution
City
W. Hollywood
State/Province
California
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Local Institution
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Norwalk
State/Province
Connecticut
Country
United States
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Washington
State/Province
District of Columbia
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United States
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Local Institution
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Atlantis
State/Province
Florida
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United States
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Daytona Beach
State/Province
Florida
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United States
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Ft. Lauderdale
State/Province
Florida
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United States
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Local Institution
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Jacksonville
State/Province
Florida
Country
United States
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City
Miami Beach
State/Province
Florida
Country
United States
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Local Institution
City
Miami
State/Province
Florida
Country
United States
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Local Institution
City
North Miami
State/Province
Florida
Country
United States
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City
Orlando
State/Province
Florida
Country
United States
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City
Plantation
State/Province
Florida
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United States
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City
Safety Harbor
State/Province
Florida
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United States
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South Miami
State/Province
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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Atlanta
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Georgia
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United States
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Decatur
State/Province
Georgia
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United States
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Chicago
State/Province
Illinois
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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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Springfield
State/Province
Massachusetts
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United States
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Kansas City
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Missouri
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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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East Orange
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New Jersey
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United States
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Newark
State/Province
New Jersey
Country
United States
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City
Union
State/Province
New Jersey
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United States
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Brooklyn
State/Province
New York
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United States
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Manhasset
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Mt. Vernon
State/Province
New York
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Stony Brook
State/Province
New York
Country
United States
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Valhalla
State/Province
New York
Country
United States
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Philadelphia
State/Province
Pennsylvania
Country
United States
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Columbia
State/Province
South Carolina
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United States
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Austin
State/Province
Texas
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United States
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Dallas
State/Province
Texas
Country
United States
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Hampton
State/Province
Virginia
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United States
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Milwaukee
State/Province
Wisconsin
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United States
Facility Name
Local Institution
City
Ponce
Country
Puerto Rico
Facility Name
Local Institution
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Rio Piedras
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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