HIV InfectionsPhase 3NCT00002441
Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection
A Phase 3 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 in people with HIV Infections and HIV Seronegativity, run by VaxGen at 67 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HIV Seronegativity
- What is being tested?
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- How many people
- 5,000 participants
- Where
- 67 sitesin 4 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.)
Trial locations and contacts
67 sites in 4 countries.
67 sites in 4 countries
United States63 sites
Albany Med College / Div of HIV Medicine
Albany, New York, 12208
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131
IDC Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Fenway Community Health Ctr
Boston, Massachusetts, 02115
AIDS Services Erie County Med Ctr
Buffalo, New York, 14215
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Univ of Illinois at Chicago / Dept of Medicine
Chicago, Illinois, 60612
Howard Brown Health Ctr
Chicago, Illinois, 60613
Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ / ACTU-Univ Clinic
Columbus, Ohio, 43210
Community AIDS Resource Inc
Coral Gables, Florida, 33146
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219
Oak Lawn Physicians / North TX Ctr for AIDS & Cln Rsch
Dallas, Texas, 75219
Denver Hlth and Hosp Authority / Dept of Pub Hlth
Denver, Colorado, 80204
Community AIDS Resource Inc
Fort Lauderdale, Florida, 33308
Univ of Texas Med Branch Ctr for Clinical Studies
Galveston, Texas, 77555
Univ of Hawaii
Honolulu, Hawaii, 96816
UTMB Ctr for Clinical Studies / St John Prof Bldg
Houston, Texas, 77058
Community Hosp Indianapolis
Indianapolis, Indiana, 46219
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
Wellness Ctr / Las Vegas
Las Vegas, Nevada, 89102
Wisconsin AIDS Research Consortium
Milwaukee, Wisconsin, 53203
Abbott Northwestern Hosp
Minneapolis, Minnesota, 55407
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415
Louisiana State Univ Med Ctr / Infect Diseases
New Orleans, Louisiana, 70112
St Luke Roosevelt Hosp
New York, New York, 10011
New York Univ Med Ctr / Dept of Environmental Med
New York, New York, 10016
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, 10029
New Jersey Community Research Initiative
Newark, New Jersey, 07103
Univ of California / UCI Med Ctr
Orange, California, 92868
ViRx Inc
Palm Springs, California, 92262
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19017
Phoenix Body Positive
Phoenix, Arizona, 85016
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania
Research and Education Group
Portland, Oregon, 97210
Dutchess County Dept of Health
Poughkeepsie, New York, 12601
Miriam Hosp
Providence, Rhode Island, 02906
Omega Med Research
Providence, Rhode Island, 02907
Community AIDS Resource Inc
Riviera Beach, Florida, 33404
Univ of Rochester Med Ctr
Rochester, New York, 14642
Univ of California - Davis Med Ctr / CARES
Sacramento, California, 95817
Park Nicollet Med Ctr / Hlth Education
Saint Louis Park, Minnesota, 55416
St Paul Public Health
Saint Paul, Minnesota, 55101
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
San Francisco Gen Hosp
San Francisco, California, 941102859
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Santa Clara Public Health Dept
San Jose, California, 95128
Univ of Washington
Seattle, Washington, 98104
Saint Louis Univ Hosp / Ctr for Vacc Dev
St Louis, Missouri, 63104
Infectious Disease Research Institute
Tampa, Florida, 33614
New York Blood Ctr
The Bronx, New York, 10456
Project Achieve - New York Blood Ctr - Women only
The Bronx, New York, 10456
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
Clinical Pharmaceutical Trials Inc / St Johns Doctors Bldg
Tulsa, Oklahoma, 74104
Johns Hopkins Univ / Ctr for Immun Rsch
Washington D.C., District of Columbia, 20003
AIDS Research Alliance
West Hollywood, California, 90069
Palm Beach Research Ctr
West Palm Beach, Florida, 33409
PW Clinical Research / LLC
Winston-Salem, North Carolina, 27103
Canada2 sites
Ctr Hosp de Universite de Montreal (CHUM)
Montreal, Quebec
St Pauls Hosp
Vancouver, British Columbia
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- Keywords
- HIV-1, Dose-Response Relationship, Drug, Acquired Immunodeficiency Syndrome, AIDS Vaccines, Sexually Transmitted Diseases, Risk Factors, HIV Seronegativity, Antigens, Viral, Alum Compounds
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- VaxGen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002441
- Sponsor's protocol ID
- VAX 004
- Status last verified
- Jan 2000
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002441
- Acronym / sponsor ID
- VAX 004
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants
- Lead sponsor
- VaxGenIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 in people with HIV Infections and HIV Seronegativity, run by VaxGen at 67 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, Netherlands, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.