ACTG A5068: WITHDRAWL OF ANTIRETROVIRALS + HIV VACCINE IN SUBJECTS W/ CD4>400

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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. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether the vaccine is safe to use in people with HIV infection. The study will also test whether stopping anti-HIV medicines for short periods of time is safe. Long-term control of HIV depends on improvement in an individual's immune system. This study will test whether occasionally stopping anti-HIV drugs has that effect. It will compare those results to those obtained by adding the HIV vaccine, ALVAC vCP1452. This HIV vaccine has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will test whether these same immune system changes happen in people with HIV. If the changes do occur, the study will also test whether these changes help to improve control of HIV in the body. This is a Phase I and Phase II study (a study that examines effectiveness and looks for side effects) lasting about 2 years. Patients who enter the study will continue receiving their anti-HIV drugs (not provided by the study). Patients will be assigned randomly (like tossing a coin) to 1 of 4 treatment groups as follows: Group A: Vaccine placebo (an inactive solution with no vaccine) and anti-HIV drugs for 92 weeks with 1 therapy withdrawal period of 12-20 weeks. Group B: Vaccine placebo and anti-HIV drugs for 84 weeks with 1 therapy withdrawal period of 4-6 weeks, a 4-week therapy withdrawal period, and 1 therapy withdrawal period of 12-20 weeks. Group C: Study vaccine (vCP1452) and anti-HIV drugs for 92 weeks with 1 therapy withdrawal period of 12-20 weeks. Group D: Study vaccine (vCP1452) and anti-HIV drugs for 84 weeks with 1 therapy withdrawal period of 4-6 weeks, a 4-week therapy withdrawal period, and 1 therapy withdrawal period of 12-20 weeks. Neither the patients nor their doctors will know if they receive the study vaccine or placebo. Half of the patients will stop their anti-HIV drugs 2 times for a period of 4-6 weeks. All patients will stop their anti-HIV drugs for 12-20 weeks after about 1 year on the study. The study has a number of different steps (8 in all). Not all steps apply to all 4 groups. All patients will return to the clinic frequently for the first year of the study and less frequently for follow-up visits during the second year. At clinic visits a short physical exam and medical history will be done and blood samples will be collected to follow viral load and CD4 counts. At 9 of these visits, vaccine or vaccine placebo injections will be given.