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
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
1 other identifier
interventional
300
2 countries
47
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.
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 Sep 2002
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedApril 25, 2011
April 1, 2011
2.8 years
August 25, 2005
April 8, 2011
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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Local Institution
Hobson City, Alabama, United States
Local Institution
Montgomery, Alabama, United States
Local Institution
Phoenix, Arizona, United States
Local Institution
Little Rock, Arkansas, United States
Local Institution
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
Denver, Colorado, United States
Local Institution
Norwalk, Connecticut, United States
Local Institution
Stratford, Connecticut, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Fort 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
Decatur, Georgia, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Indianapolis, Indiana, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
Baltimore, Maryland, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Berkley, Michigan, United States
Local Institution
Detroit, Michigan, United States
Local Institution
St Louis, Missouri, United States
Local Institution
Las Vegas, Nevada, United States
Local Institution
Hackensack, New Jersey, United States
Local Institution
Jersey City, New Jersey, United States
Local Institution
Neptune City, New Jersey, United States
Local Institution
Somers Point, New Jersey, United States
Local Institution
Manhasset, New York, United States
Local Institution
New York, New York, United States
Local Institution
The Bronx, New York, United States
Local Institution
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
Philadelphia, Pennsylvania, United States
Local Institution
Reading, Pennsylvania, United States
Local Institution
Dallas, Texas, United States
Local Institution
Galveston, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Annandale, Virginia, United States
Local Institution
Hampton, Virginia, United States
Local Institution
Seattle, Washington, United States
Local Institution
San Juan, 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
September 1, 2002
Primary Completion
July 1, 2005
Study Completion
July 1, 2005
Last Updated
April 25, 2011
Record last verified: 2011-04