CT 2001 A STAGED PHASE I STUDY OF THE TREATMENT OF MALIGNANT GLIOMA WITH G207,

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5068 is a randomized phase I/II pilot study intended to evaluate the safety, antiviral effects and immunological effects of intermittent withdrawal of potent antiretroviral therapy as an immunization strategy, ALVAC-HIV immunization, and the two strategies combined. The primary objectives are to compare the effect of different methods of antigen stimulation (intermittent potent ART withdrawal versus ALVAC versus both) versus no antigen stimulation on the mean of the log10 HIV-1 RNA copies/mL in the last 2 weeks of the endpoint readout period (Step 6) of potent ART withdrawal, and to establish the safety of intermittent withdrawal of antiretroviral therapy with and without HIV-specific vaccine in subjects with persistent CD4+ T-cell counts >400/mm3 and persistent plasma HIV-1 RNA levels <50 copies/mL. Subjects will be randomized in equal numbers (25 per arm) to one of four arms: Arm A: Placebo immunization (ALVAC placebo) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period. Arm B: Placebo immunization (ALVAC placebo) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period. Arm C: Vaccine immunization (ALVAC vCP1452) + potent ART for 92 weeks with one 12- to 20-week therapy withdrawal period. Arm D: Vaccine immunization (ALVAC vCP1452) + potent ART for 84 weeks with one 4- to 6-week therapy withdrawal period, one 4-week therapy withdrawal period, and one 12- to 20-week therapy withdrawal period.