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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Biological: HIV-1 Immunogen	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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 Regardless of Concomitant HIV Therapies

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

3000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

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

Concurrent Medication:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002359

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Locations

United States, Arizona
Phoenix Body Positive
Phoenix, Arizona, United States, 85016
United States, California
Ctr for Special Immunology
Irvine, California, United States, 92718
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Jeffrey Goodman Special Care Clinic
Los Angeles, California, United States, 90028
Kraus Med Partners
Los Angeles, California, United States, 90036
AIDS Community Research Consortium
Redwood City, California, United States, 94063
United States, District of Columbia
Whitman Walker Clinic Inc
Washington, District of Columbia, United States, 20009
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Anderson Clinical Research
Washington, District of Columbia, United States, 20037
United States, Florida
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
Ctr for Special Immunology
Miami Beach, Florida, United States, 33140
The Coleman Institute
North Miami, Florida, United States, 33179
Clinical Pharmacology Services
Tampa, Florida, United States, 33617
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Ctr for Special Immunology
Chicago, Illinois, United States, 60657
Rush Med Ctr
Chicago, Illinois, United States, 60612
Chicago AIDS Research Alliance
Chicago, Illinois, United States, 60657
United States, Indiana
Community Hosp Indianapolis
Indianapolis, Indiana, United States, 46219
United States, Kansas
UKSM-W Med Practice Association
Wichita, Kansas, United States, 67214
United States, Kentucky
Univ of Kentucky / Division of ID Research
Lexington, Kentucky, United States, 40536
United States, Massachusetts
JSI Research and Training Institute
Boston, Massachusetts, United States, 02210
Community Research Initiative of New England
Brookline Village, Massachusetts, United States, 02445
Providence Mercy Hosp
Holyoke, Massachusetts, United States, 01040
United States, Michigan
Henry Ford Hosp / Infectious Diseases
Detroit, Michigan, United States, 48202
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, United States, 48201
United States, Minnesota
Abbott Northwestern Hosp
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States, 64111
Washington Univ / St Louis Connect Care
Saint Louis, Missouri, United States, 63108
United States, New York
Bronx Lebanon Hosp Ctr
Bronx, New York, United States, 10456
Dr Barbara Justice
New York, New York, United States, 10031
Mount Sinai Med Ctr
New York, New York, United States, 10029
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York, New York, United States, 10019
Anderson Clinical Research
New York, New York, United States, 10016
Cornell Univ Med College
New York, New York, United States, 10021
Community Health Network
Rochester, New York, United States, 14620
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
United States, Ohio
Univ of Cincinnati Med Ctr / Holmes Division
Cincinnati, Ohio, United States, 45267
Ohio State Univ / Division of Infectious Disease
Columbus, Ohio, United States, 43210
United States, Oklahoma
Univ of Oklahoma
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
The Research and Education Group
Portland, Oregon, United States, 97210
United States, Pennsylvania
The Graduate Hosp
Philadelphia, Pennsylvania, United States, 19146
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15218
United States, Rhode Island
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Med Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37212
United States, Texas
Metroplex Clinical Research Ctr
Dallas, Texas, United States, 75235
Univ of Texas Med Branch Ctr for Clinical Studies
Galveston, Texas, United States, 77555
ONCOL Med Associates / PA
Houston, Texas, United States, 77027
United States, Utah
Univ of Utah Med School / Clinical Trials Ctr
Salt Lake City, Utah, United States, 84108
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22003
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Eastern Virginia Med School
Norfolk, Virginia, United States, 23507
United States, Washington
Novum Inc
Seattle, Washington, United States, 98104
United States, Wisconsin
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, United States, 53203

Sponsors and Collaborators

The Immune Response Corporation

More Information

Publications:

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. Erratum in: JAMA 2001 May 2;285(17):2197.

ClinicalTrials.gov Identifier:	NCT00002359 History of Changes
Other Study ID Numbers:	092, 806
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Vaccines, Synthetic
Viral Vaccines
HIV-1

AIDS-Related Complex
AIDS Vaccines
Salk HIV Immunogen

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Adjuvants, Immunologic
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013