MERCK Ad5 vaccine

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New York University School of Medicine | Center for AIDS Research | | www.HIVinfoSource.orgA5197

This study is for people who are on antiretroviral medications and are successfully suppressing their HIV Viral Load. We want to find out if the use of the MERCK Ad5 vaccine will help people continue to suppress their Viral Load even when they go 16 weeks without taking their antiretroviral medications [treatment interruption].Patient Population: -CD4-TCell count greater than 500 at the time of study screening. -Viral Load [HIV-1 RNA]: At least one documented HIV-1 RNA level of 1000 copies/mL within 2 years before first starting antiretroviral medications AND documentation that within the last 2 years you have suppression of HIV RNA. Please contact the study team about the specifics. -You are on a stable ART regimen (no changes in therapy) for a minimum of 4 weeks prior to study entry. -Willingness to interrupt all ART for at least 16 weeks following completion of vaccination. -Have never received a HIV vaccine. -Not pregnant or planning to become pregnant Study Objective: -To determine if the MRK Ad5 vaccine has an effect of maintaining viral suppression following interruption of ART over 16 weeks post-AntiReTroviral interruption, versus placebo. -To learn about the safety and tolerance of this HIV treatment vaccine Study Scheme: The study will be conducted in four Phases: Day 1 through week 38 is Phase I, the immunization phase. Participants will continue anti-HIV medications and will also receive injections with either an experimental HIV vaccine or a placebo (looks like the HIV vaccine but does not contain any active medicine). Week 39 through week 54 is the ART interruption phase. This is the scheduled period where medications are stopped and participants are carefully monitored. Week 55 through week 87 is the fourth phase, Follow-up. Participants either continue interruption of all antiretrovirals or resume their antiretroviral medications. The long term follow-up is the last phase of this study. Follow-up continues through week 240. Study Drugs: Adenovirus Serotype 5 Vector (MRKAd5) Human Immunodeficiency Virus Type 1 (HIV-1) gag vaccineStudy Status: Open for enrollmentStudy Staff: MD Cavanagh RN Study Sponsors: AIDS Clinical Trials Group [NIH]Study Volunteers Receive: -Vaccine will be provided for free. Antiretroviral therapies will not be provided as part of this study -Lab work and medical evaluations more frequently during the Scheduled Treatment Interruption. -Transportation reimbursement

New York University School of Medicine | Center for AIDS Research | | www.HIVinfoSource.org

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