Clinical trial NCT00002359: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Vaccines, Synthetic
Viral Vaccines
HIV-1
AIDS-Related Complex
AIDS Vaccines
Salk HIV Immunogen
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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.

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