A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
- Conditions
- HIV Infections
- Registration Number
- NCT00002359
- Lead Sponsor
- The Immune Response Corporation
- Brief Summary
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.
- Detailed Description
Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Kraus Med Partners
🇺🇸Los Angeles, California, United States
Cedars Sinai Med Ctr
🇺🇸Los Angeles, California, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Rush Med Ctr
🇺🇸Chicago, Illinois, United States
JSI Research and Training Institute
🇺🇸Boston, Massachusetts, United States
Metroplex Clinical Research Ctr
🇺🇸Dallas, Texas, United States
The Graduate Hosp
🇺🇸Philadelphia, Pennsylvania, United States
ONCOL Med Associates / PA
🇺🇸Houston, Texas, United States
Novum Inc
🇺🇸Seattle, Washington, United States
UKSM-W Med Practice Association
🇺🇸Wichita, Kansas, United States
Phoenix Body Positive
🇺🇸Phoenix, Arizona, United States
Whitman Walker Clinic Inc
🇺🇸Washington, District of Columbia, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Ctr for Special Immunology
🇺🇸Chicago, Illinois, United States
Jeffrey Goodman Special Care Clinic
🇺🇸Los Angeles, California, United States
Clinical Pharmacology Services
🇺🇸Tampa, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Univ of Texas Med Branch Ctr for Clinical Studies
🇺🇸Galveston, Texas, United States
Community Hosp Indianapolis
🇺🇸Indianapolis, Indiana, United States
Wayne State Univ / WSU / DMC HIV / AIDS Program
🇺🇸Detroit, Michigan, United States
Univ of Cincinnati Med Ctr / Holmes Division
🇺🇸Cincinnati, Ohio, United States
Community Research Initiative of New England
🇺🇸Brookline Village, Massachusetts, United States
Abbott Northwestern Hosp
🇺🇸Minneapolis, Minnesota, United States
Nalle Clinic
🇺🇸Charlotte, North Carolina, United States
Univ of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
🇺🇸New York, New York, United States
Mem Hosp of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Dr Barbara Justice
🇺🇸New York, New York, United States
Community Health Network
🇺🇸Rochester, New York, United States
Ohio State Univ / Division of Infectious Disease
🇺🇸Columbus, Ohio, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States
The Coleman Institute
🇺🇸North Miami, Florida, United States
Providence Mercy Hosp
🇺🇸Holyoke, Massachusetts, United States
Chicago AIDS Research Alliance
🇺🇸Chicago, Illinois, United States
Univ of Kentucky / Division of ID Research
🇺🇸Lexington, Kentucky, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Eastern Virginia Med School
🇺🇸Norfolk, Virginia, United States
Henry Ford Hosp / Infectious Diseases
🇺🇸Detroit, Michigan, United States
Washington Univ / St Louis Connect Care
🇺🇸Saint Louis, Missouri, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Univ of Utah Med School / Clinical Trials Ctr
🇺🇸Salt Lake City, Utah, United States
Wisconsin AIDS Research Consortium
🇺🇸Milwaukee, Wisconsin, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States