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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002359
• Other study ID #: 092
• Secondary ID: 806
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infection

Intervention

Biological:
• HIV-1 Immunogen

Locations

Country	Name	City	State
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	JSI Research and Training Institute	Boston	Massachusetts
United States	Bronx Lebanon Hosp Ctr	Bronx	New York
United States	Community Research Initiative of New England	Brookline Village	Massachusetts
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Nalle Clinic	Charlotte	North Carolina
United States	Chicago AIDS Research Alliance	Chicago	Illinois
United States	Ctr for Special Immunology	Chicago	Illinois
United States	Rush Med Ctr	Chicago	Illinois
United States	Univ of Cincinnati Med Ctr / Holmes Division	Cincinnati	Ohio
United States	Ohio State Univ / Division of Infectious Disease	Columbus	Ohio
United States	Metroplex Clinical Research Ctr	Dallas	Texas
United States	Henry Ford Hosp / Infectious Diseases	Detroit	Michigan
United States	Wayne State Univ / WSU / DMC HIV / AIDS Program	Detroit	Michigan
United States	North Broward Hosp District	Fort Lauderdale	Florida
United States	Univ of Texas Med Branch Ctr for Clinical Studies	Galveston	Texas
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Providence Mercy Hosp	Holyoke	Massachusetts
United States	ONCOL Med Associates / PA	Houston	Texas
United States	Community Hosp Indianapolis	Indianapolis	Indiana
United States	Ctr for Special Immunology	Irvine	California
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Univ of Kentucky / Division of ID Research	Lexington	Kentucky
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Jeffrey Goodman Special Care Clinic	Los Angeles	California
United States	Kraus Med Partners	Los Angeles	California
United States	Ctr for Special Immunology	Miami Beach	Florida
United States	Wisconsin AIDS Research Consortium	Milwaukee	Wisconsin
United States	Abbott Northwestern Hosp	Minneapolis	Minnesota
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Anderson Clinical Research	New York	New York
United States	Cornell Univ Med College	New York	New York
United States	Dr Barbara Justice	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis	New York	New York
United States	Eastern Virginia Med School	Norfolk	Virginia
United States	The Coleman Institute	North Miami	Florida
United States	Univ of Oklahoma	Oklahoma City	Oklahoma
United States	Mem Hosp of Rhode Island	Pawtucket	Rhode Island
United States	The Graduate Hosp	Philadelphia	Pennsylvania
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	AIDS Community Research Consortium	Redwood City	California
United States	Community Health Network	Rochester	New York
United States	Washington Univ / St Louis Connect Care	Saint Louis	Missouri
United States	Univ of Utah Med School / Clinical Trials Ctr	Salt Lake City	Utah
United States	Novum Inc	Seattle	Washington
United States	Clinical Pharmacology Services	Tampa	Florida
United States	Anderson Clinical Research	Washington	District of Columbia
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Whitman Walker Clinic Inc	Washington	District of Columbia
United States	UKSM-W Med Practice Association	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
The Immune Response Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation