Back to resultsA 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HIV-1 Immunogen
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, Viral Vaccines, HIV-1, AIDS-Related Complex, AIDS Vaccines, Salk HIV Immunogen
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.
Sites / Locations
- Phoenix Body Positive
- Ctr for Special Immunology
- Jeffrey Goodman Special Care Clinic
- Kraus Med Partners
- Cedars Sinai Med Ctr
- AIDS Community Research Consortium
- Whitman Walker Clinic Inc
- Anderson Clinical Research
- George Washington Univ Med Ctr
- North Broward Hosp District
- Ctr for Special Immunology
- The Coleman Institute
- Clinical Pharmacology Services
- AIDS Research Consortium of Atlanta
- Rush Med Ctr
- Chicago AIDS Research Alliance
- Ctr for Special Immunology
- Community Hosp Indianapolis
- UKSM-W Med Practice Association
- Univ of Kentucky / Division of ID Research
- JSI Research and Training Institute
- Community Research Initiative of New England
- Providence Mercy Hosp
- Wayne State Univ / WSU / DMC HIV / AIDS Program
- Henry Ford Hosp / Infectious Diseases
- Abbott Northwestern Hosp
- Kansas City AIDS Research Consortium
- Washington Univ / St Louis Connect Care
- Bronx Lebanon Hosp Ctr
- Anderson Clinical Research
- St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
- Cornell Univ Med College
- Mount Sinai Med Ctr
- Dr Barbara Justice
- Community Health Network
- Nalle Clinic
- Univ of Cincinnati Med Ctr / Holmes Division
- Ohio State Univ / Division of Infectious Disease
- Univ of Oklahoma
- The Research and Education Group
- The Graduate Hosp
- Anderson Clinical Research
- Mem Hosp of Rhode Island
- Med Univ of South Carolina
- Vanderbilt Univ Med Ctr
- Metroplex Clinical Research Ctr
- Univ of Texas Med Branch Ctr for Clinical Studies
- ONCOL Med Associates / PA
- Univ of Utah Med School / Clinical Trials Ctr
- Infectious Disease Physicians Inc
- Hampton Roads Med Specialists
- Eastern Virginia Med School
- Novum Inc
- Wisconsin AIDS Research Consortium
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002359
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
The Immune Response Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00002359
Brief 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 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
2. Study Status
Record Verification Date
June 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Immune Response Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Viral Vaccines, HIV-1, AIDS-Related Complex, AIDS Vaccines, Salk HIV Immunogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
3000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
HIV-1 Immunogen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Ctr for Special Immunology
City
Irvine
State/Province
California
ZIP/Postal Code
92718
Country
United States
Facility Name
Jeffrey Goodman Special Care Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Kraus Med Partners
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars Sinai Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
AIDS Community Research Consortium
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Whitman Walker Clinic Inc
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Anderson Clinical Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Ctr for Special Immunology
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
The Coleman Institute
City
North Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Clinical Pharmacology Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rush Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago AIDS Research Alliance
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Ctr for Special Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Community Hosp Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
UKSM-W Med Practice Association
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Univ of Kentucky / Division of ID Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
JSI Research and Training Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02210
Country
United States
Facility Name
Community Research Initiative of New England
City
Brookline Village
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Providence Mercy Hosp
City
Holyoke
State/Province
Massachusetts
ZIP/Postal Code
01040
Country
United States
Facility Name
Wayne State Univ / WSU / DMC HIV / AIDS Program
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp / Infectious Diseases
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Abbott Northwestern Hosp
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Kansas City AIDS Research Consortium
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington Univ / St Louis Connect Care
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Anderson Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dr Barbara Justice
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Univ of Cincinnati Med Ctr / Holmes Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Ohio State Univ / Division of Infectious Disease
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Univ of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
The Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
The Graduate Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Facility Name
Mem Hosp of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Metroplex Clinical Research Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ of Texas Med Branch Ctr for Clinical Studies
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
ONCOL Med Associates / PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Univ of Utah Med School / Clinical Trials Ctr
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Eastern Virginia Med School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novum Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Wisconsin AIDS Research Consortium
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11056590
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. Erratum In: JAMA 2001 May 2;285(17):2197.
Results Reference
background
PubMed Identifier
28154006
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.
Results Reference
derived
Learn more about this trial
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
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