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 Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
1 other identifier
interventional
254
2 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Jun 2002
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFebruary 17, 2010
January 1, 2010
3.3 years
August 25, 2005
January 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy at week 48
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Local Institution
Little Rock, Arkansas, United States
Local Institution
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
West Hollywood, California, United States
Local Institution
Denver, Colorado, United States
Local Institution
Norwalk, Connecticut, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Atlantis, Florida, United States
Local Institution
Daytona Beach, Florida, United States
Local Institution
Fort 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
Atlanta, Georgia, United States
Local Institution
Decatur, Georgia, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Kansas City, Missouri, United States
Local Institution
St Louis, Missouri, United States
Local Institution
East Orange, New Jersey, United States
Local Institution
Newark, New Jersey, United States
Local Institution
Union, New Jersey, United States
Local Institution
Brooklyn, New York, United States
Local Institution
Manhasset, New York, United States
Local Institution
Mount 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
Philadelphia, Pennsylvania, United States
Local Institution
Columbia, South Carolina, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Hampton, Virginia, United States
Local Institution
Milwaukee, Wisconsin, United States
Local Institution
Ponce, Puerto Rico
Local Institution
Rio Piedras, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
June 1, 2002
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
February 17, 2010
Record last verified: 2010-01