HIV Infections Clinical Trial
Official title:
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in
HIV-infected persons. To determine the proportion of study participants immunized who
develop new specificities or increased levels of neutralizing and other antibody responses,
T-cell proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL )
responses.
HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes
from four of the most common HIV isolates in the United States and Europe, predicted to
represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes
that generate potentially salutary immune responses and deletes epitopes that generate
immune responses which might contribute to further immunopathogenesis.
HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes
from four of the most common HIV isolates in the United States and Europe, predicted to
represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes
that generate potentially salutary immune responses and deletes epitopes that generate
immune responses which might contribute to further immunopathogenesis.
Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide
vaccine in incomplete Freund's adjuvant (IFA), or IFA alone as control. Injections are
administered on day 0 and at weeks 4, 8, 12, and 24. When patients entered at the lower
vaccine dose (Cohort A) reach week 6, the data is reviewed and the higher dose cohort
(Cohort B) will begin. When both cohorts reach week 14, data is evaluated and Cohort C
begins vaccine administrations at a chosen vaccine dose. Within each cohort, eight patients
receive vaccine plus IFA and two patients receive IFA alone. Patients are followed to week
52; 18 clinic visits and four telephone calls are required.
;
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention
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