Back to resultsEffectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
Primary Purpose
HIV Infections, HIV Seronegativity
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, Sexually Transmitted Diseases, Risk Factors, HIV Seronegativity, Antigens, Viral, Alum Compounds
Eligibility Criteria
Exclusion Criteria You will not be eligible for this study if you: Use injection drugs. Have a history of any serious diseases or conditions, including lymphoma. Have ever received an HIV vaccine. Have taken post-exposure treatment to prevent HIV infection within 4 weeks prior to study entry. Are planning to take other HIV vaccines during this study. Are pregnant. Have taken certain medications or received certain therapies, including chemotherapy and radiation. Have received certain vaccines within 2-4 weeks prior to study entry. You may be eligible for this study if you: Are HIV-negative. Are between 18 and 60 years old. Are available for 3 years of follow-up. Agree to use effective methods of birth control during the study and for 90 days after. Are one of the following: A woman who is currently in a sexual relationship with an HIV-positive man. A woman who has had more than one male partner and at least one sexually transmitted disease (STD) within the past 12 months. A man who has sex with men and has had anal intercourse within the past 12 months. (You will not be eligible if you have been in the same relationship with only one HIV-negative man for at least 12 months.)
Sites / Locations
- Univ of Alabama at Birmingham
- Phoenix Body Positive
- Arizona Clinical Research Ctr Inc
- Univ of California / UCI Med Ctr
- ViRx Inc
- Univ of California - Davis Med Ctr / CARES
- San Francisco Dept of Hlth / AIDS Office
- San Francisco Gen Hosp
- UCSF - San Francisco Gen Hosp
- Santa Clara Public Health Dept
- AIDS Research Alliance
- Denver Hlth and Hosp Authority / Dept of Pub Hlth
- Johns Hopkins Univ / Ctr for Immun Rsch
- IDC Research Initiative
- Community AIDS Resource Inc
- Community AIDS Resource Inc
- Boulevard Comprehensive Care Ctr
- Community AIDS Resource Inc
- Infectious Disease Research Institute
- Palm Beach Research Ctr
- AIDS Research Consortium of Atlanta
- Univ of Hawaii
- Chicago Ctr for Clinical Research
- Univ of Illinois at Chicago / Dept of Medicine
- Howard Brown Health Ctr
- Community Hosp Indianapolis
- Louisiana State Univ Med Ctr / Infect Diseases
- Fenway Community Health Ctr
- Abbott Northwestern Hosp
- Hennepin County Med Ctr
- Park Nicollet Med Ctr / Hlth Education
- St Paul Public Health
- Kansas City AIDS Research Consortium
- Saint Louis Univ Hosp / Ctr for Vacc Dev
- Wellness Ctr / Las Vegas
- New Jersey Community Research Initiative
- Univ of New Mexico Hlth Sciences Ctr / Dept of Med
- Albany Med College / Div of HIV Medicine
- New York Blood Ctr
- Project Achieve - New York Blood Ctr - Women only
- AIDS Services Erie County Med Ctr
- St Luke Roosevelt Hosp
- New York Univ Med Ctr / Dept of Environmental Med
- Mount Sinai Med Ctr / Jack Martin Fund Clinic
- Dutchess County Dept of Health
- Univ of Rochester Med Ctr
- Nalle Clinic / Clinical Research Dept
- PW Clinical Research / LLC
- Case Western Reserve Univ
- Ohio State Univ / ACTU-Univ Clinic
- Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
- Research and Education Group
- Philadelphia FIGHT
- Univ of Pittsburgh Med School
- Mem Hosp of Rhode Island
- Miriam Hosp
- Omega Med Research
- Nelson Tebedo Health Resource Ctr
- Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
- Univ of Texas Med Branch Ctr for Clinical Studies
- UTMB Ctr for Clinical Studies / St John Prof Bldg
- Univ of Washington
- Wisconsin AIDS Research Consortium
- St Pauls Hosp
- Ctr Hosp de Universite de Montreal (CHUM)
- Municipal Health Service
- Clinical Research of Puerto Rico Inc
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002441
Brief Title
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
Official Title
A Phase III Trial to Determine the Efficacy of Bivalent AIDSVAX B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in North America
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
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
VaxGen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if an HIV vaccine, AIDSVAX B/B, can protect adults who are at risk from becoming infected with HIV. Patients who become infected despite immunization will be studied to see if receiving the vaccine before becoming infected will help keep HIV levels (viral load) low.
Detailed Description
Volunteers receive 7 blinded, intramuscular vaccinations (at Months 0, 1, 6, 12, 18, 24, 30) containing either the AIDSVAX B/B vaccine or a placebo (aluminum adjuvant only). Volunteers are randomized in a 2 to 1 vaccine-to-placebo ratio. HIV-uninfected persons are followed for a total of 16 visits beginning at screening and continuing until Month 36. Patients who become HIV infected during study are followed every 4 months for at least 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, Sexually Transmitted Diseases, Risk Factors, HIV Seronegativity, Antigens, Viral, Alum Compounds
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Enrollment
5000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria
You will not be eligible for this study if you:
Use injection drugs.
Have a history of any serious diseases or conditions, including lymphoma.
Have ever received an HIV vaccine.
Have taken post-exposure treatment to prevent HIV infection within 4 weeks prior to study entry.
Are planning to take other HIV vaccines during this study.
Are pregnant.
Have taken certain medications or received certain therapies, including chemotherapy and radiation.
Have received certain vaccines within 2-4 weeks prior to study entry.
You may be eligible for this study if you:
Are HIV-negative.
Are between 18 and 60 years old.
Are available for 3 years of follow-up.
Agree to use effective methods of birth control during the study and for 90 days after.
Are one of the following:
A woman who is currently in a sexual relationship with an HIV-positive man.
A woman who has had more than one male partner and at least one sexually transmitted disease (STD) within the past 12 months.
A man who has sex with men and has had anal intercourse within the past 12 months. (You will not be eligible if you have been in the same relationship with only one HIV-negative man for at least 12 months.)
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arizona Clinical Research Ctr Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Univ of California / UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
ViRx Inc
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Univ of California - Davis Med Ctr / CARES
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
San Francisco Dept of Hlth / AIDS Office
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Santa Clara Public Health Dept
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Denver Hlth and Hosp Authority / Dept of Pub Hlth
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Johns Hopkins Univ / Ctr for Immun Rsch
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Community AIDS Resource Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Community AIDS Resource Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Boulevard Comprehensive Care Ctr
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Community AIDS Resource Inc
City
Riviera Beach
State/Province
Florida
ZIP/Postal Code
33404
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Palm Beach Research Ctr
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Univ of Illinois at Chicago / Dept of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Howard Brown Health Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Community Hosp Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Louisiana State Univ Med Ctr / Infect Diseases
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Fenway Community Health Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Abbott Northwestern Hosp
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Med Ctr
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Park Nicollet Med Ctr / Hlth Education
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St Paul Public Health
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
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
Saint Louis Univ Hosp / Ctr for Vacc Dev
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Wellness Ctr / Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
New Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albany Med College / Div of HIV Medicine
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Blood Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
Project Achieve - New York Blood Ctr - Women only
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Facility Name
AIDS Services Erie County Med Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
St Luke Roosevelt Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
New York Univ Med Ctr / Dept of Environmental Med
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Med Ctr / Jack Martin Fund Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Dutchess County Dept of Health
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Nalle Clinic / Clinical Research Dept
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
PW Clinical Research / LLC
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State Univ / ACTU-Univ Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Research and Education Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States
Facility Name
Univ of Pittsburgh Med School
City
Pittsburgh
State/Province
Pennsylvania
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
Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Omega Med Research
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02907
Country
United States
Facility Name
Nelson Tebedo Health Resource Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
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
UTMB Ctr for Clinical Studies / St John Prof Bldg
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Univ of Washington
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
Facility Name
St Pauls Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Ctr Hosp de Universite de Montreal (CHUM)
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Municipal Health Service
City
Amsterdam
Country
Netherlands
Facility Name
Clinical Research of Puerto Rico Inc
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
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