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. This is a multicenter prospective randomized unmasked Phase II study of two groups of subjects who have successfully suppressed their HIV-1 RNA levels for a minimum of 6 months prior to randomization. Randomization will be block-stratified within center. The pre-randomization therapy for both groups will be highly active antiretroviral therapy (HAART) (including a protease inhibitor). The comparison of the two groups will assess the impact of switching from continuation HAART with a PI to short-cycle therapy (SCT). This is a non-inferiority trial with the primary objective of showing that the rate of viral load rebound in the SCT arm does not exceed that in the continuous HAART arm by an amount that would lead to concerns about the safety of SCT. While maintenace of viral load suppression can be viewed as either a safety or efficacy endpoint, the trial is construed as an assessment of safety. Adherence will be studied as a secondary objective as part of clinical and safety monitoring in the protocol; medication adherence measures will be conducted every two weeks.
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