REPREIVE is a landmark trial funded by NIH in 2014, as the first major primary prevention trial for major adverse cardiovascular events (MACE) in persons living with HIV. Key secondary aims include all-cause mortality, delineation of the mechanisms of cardiovascular disease (CVD) in HIV, as well as statin effects on AIDS, non-AIDS events, classification of MI type and safety. REPRIEVE has been very successful in creating a robust international network of 117 sites in 10 countries recruiting its initial goal of 6500 participants. However, in light of MACE rates which are lower than trial assumptions, the DSMB has recommended that REPREIVE restrict lower CVD risk participants, enroll up to 8000 participants and extend maximal follow up to assure adequate power to determine the prespecified HR of 0.7. In order to assure successful completion of these trial goals, REPREIVE needs to enroll additional participants beyond the 6500 participants funded in the primary grant. Recruitment of these additional participants must be accomplished as quickly as possible, within the current grant year, to assure the longest maximal follow up time. Critically these funds are needed to implement recruitment strategies to identify and enroll higher risk participants, pay for related site costs of additionally enrolled participants, retain participants through their initial first year of study, when dropout rates are traditionally the highest, and to process and store the large number of specimens and other data that will be generated during the first year of the study from these participants. Additional support is also needed for the Clinical Coordinating Center to achieve these goals, which are beyond those set out in the scope of the primary grant. In summary, this administrative supplement is critical and will enable REPREIVE to achieve its Aims, through expedited enrollment and processing of additional participants in the current grant year.
This administrative supplement will help to insure that REPRIEVE achieves its goal to determine if a statin medication prevents heart disease in HIV patients. Preliminary analyses indicate there is a need to enroll more participants than originally planned into the study. To be useful this enrollment must occur in the current grant period. This additional enrollment can only be accomplished with supplemental funds.
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