A Phase I/II Safety and Immunogenicity Evaluation of a Prime/Boost Vaccine Using ALVAC-HIV (vCP 1452) With Recombinant gp160 LAI/MN-2 in HIV-Infected Subjects Treated With Antiretroviral Therapy for a Minimum of 2 Years

HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested.

Patients continue antiretroviral medications throughout the course of this study. All patients receive intramuscular injections of ALVAC-HIV (vCP 1452) and recombinant soluble gp160 MN/LAI-2 on Days 0, 30, 90, and 180. Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.