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
NCT ID: NCT00002359
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3000 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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HIV-1 Immunogen
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Antiretrovirals if on a stable dose for at least the past 3 months.
Patients must have:
* HIV-1 infection with CD4 count 300-549 cells/mm3.
* No AIDS-defining condition.
* Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.
NOTE:
* KS is permitted if not requiring systemic therapy.
Prior Medication:
Allowed:
* Prior antiretrovirals.
Exclusion Criteria
Excluded:
* Systemic chemotherapy for KS.
* Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Patients with the following prior conditions are excluded:
* History of any illness that would interfere with study.
* Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.
Prior Medication:
Excluded:
* Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.
18 Years
ALL
No
Sponsors
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The Immune Response Corporation
INDUSTRY
Locations
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Phoenix Body Positive
Phoenix, Arizona, United States
Ctr for Special Immunology
Irvine, California, United States
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States
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
Whitman Walker Clinic Inc
Washington D.C., District of Columbia, United States
Anderson Clinical Research
Washington D.C., District of Columbia, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Ctr for Special Immunology
Miami Beach, Florida, United States
The Coleman Institute
North Miami, Florida, United States
Clinical Pharmacology Services
Tampa, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Rush Med Ctr
Chicago, Illinois, United States
Chicago AIDS Research Alliance
Chicago, Illinois, United States
Ctr for Special Immunology
Chicago, Illinois, United States
Community Hosp Indianapolis
Indianapolis, Indiana, United States
UKSM-W Med Practice Association
Wichita, Kansas, United States
Univ of Kentucky / Division of ID Research
Lexington, Kentucky, United States
JSI Research and Training Institute
Boston, Massachusetts, United States
Community Research Initiative of New England
Brookline Village, Massachusetts, United States
Providence Mercy Hosp
Holyoke, Massachusetts, United States
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, United States
Henry Ford Hosp / Infectious Diseases
Detroit, Michigan, United States
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
Washington Univ / St Louis Connect Care
St Louis, Missouri, United States
Anderson Clinical Research
New York, New York, United States
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York, New York, United States
Cornell Univ Med College
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Dr Barbara Justice
New York, New York, United States
Community Health Network
Rochester, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Nalle Clinic
Charlotte, North Carolina, United States
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, United States
Ohio State Univ / Division of Infectious Disease
Columbus, Ohio, United States
Univ of Oklahoma
Oklahoma City, Oklahoma, United States
The Research and Education Group
Portland, Oregon, United States
The Graduate Hosp
Philadelphia, Pennsylvania, United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Metroplex Clinical Research Ctr
Dallas, Texas, United States
Univ of Texas Med Branch Ctr for Clinical Studies
Galveston, Texas, United States
ONCOL Med Associates / PA
Houston, Texas, United States
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Eastern Virginia Med School
Norfolk, Virginia, United States
Novum Inc
Seattle, Washington, United States
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, United States
Countries
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References
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Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial. JAMA. 2000 Nov 1;284(17):2193-202. doi: 10.1001/jama.284.17.2193.
Rao MP, Al-Khatib SM, Pokorney SD, She L, Romanov A, Nicolau JC, Lee KL, Carson P, Selzman CH, Stepinska J, Cleland JG, Tungsubutra W, Desvigne-Nickens PM, Sueta CA, Siepe M, Lang I, Feldman AM, Yii M, Rouleau JL, Velazquez EJ; STICH Trial Investigators. Sudden Cardiac Death in Patients With Ischemic Heart Failure Undergoing Coronary Artery Bypass Grafting: Results From the STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2017 Mar 21;135(12):1136-1144. doi: 10.1161/CIRCULATIONAHA.116.026075. Epub 2017 Feb 2.
Other Identifiers
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806
Identifier Type: -
Identifier Source: secondary_id
092
Identifier Type: -
Identifier Source: org_study_id