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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002441 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effectiveness of an HIV Vaccine in HIV-Negative Adults in North America Who Are at Risk of HIV Infection |
| Official Title ICMJE | 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 |
| 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. |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Double-Blind, Safety Study |
| Condition ICMJE |
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| Intervention ICMJE | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 5000 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Exclusion Criteria You will not be eligible for this study if you:
You may be eligible for this study if you:
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| Gender | Both |
| Ages | 18 Years to 60 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada, Netherlands, Puerto Rico |
| Administrative Information | |
| NCT ID ICMJE | NCT00002441 |
| Responsible Party | |
| Study ID Numbers ICMJE | VAX 004 |
| Study Sponsor ICMJE | VaxGen |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | January 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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