A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
- Conditions
- HIV Infections
- Registration Number
- NCT00000779
- Brief Summary
PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
SECONDARY: To determine whether significant advantages to any one vaccine exist.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
- Detailed Description
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States