General Information
Ancillary studies are investigations that are not part of the REPRIEVE (A5332) trial, but that propose questions and test hypotheses that are relevant to and further the goals and purposes of REPRIEVE. It is recognized that well designed ancillary studies, consistent with the goals of REPRIEVE, can leverage the trial’s resources to provide critical answers to highly relevant questions for the field. Successful ancillary studies should be able to secure adequate funding through peer review, either through the ACTG, NIH or other funding sources. To protect the integrity of the REPRIEVE trial, ancillary study proposals must be reviewed and approved by the REPRIEVE Ancillary Studies Committee and the Data and Safety Monitoring Board (DSMB) prior to implementation. In addition to meeting the standard for high scientific merit, the major criterion for approval of an ancillary study is that it does not negatively impact the conduct of the parent REPRIEVE trial.
Definition
A REPRIEVE ancillary study is defined as research that (1) has not been previously described in the REPRIEVE trial protocol (2) derives new data through the collection of additional imaging, biomarkers, or additional clinical data during the course of the trial (3) does not interfere with the goals and objectives of the REPRIEVE and (4) follows all policies and procedures of the REPRIEVE trial.
Currently Funded Ancillary Objectives
Sex-Specific Mechanisms of Cardiovascular Disease Risk and Risk Reduction
Principal Investigators: Markella Zanni, MD and Sara Looby, PhD, MSN
Primary Objective: To assess among individuals with HIV ages 40-75 sex-based differences in immune activation in relation to heart disease events and statin-induced immunomodulation in relation to clinical cardiovascular disease events.
Evaluate the Effect of Pitavastatin on Kidney Function in Persons with HIV
Principal Investigator: Edgar Turner Overton, MD
Primary Objective: To evaluate the effects of pitavastatin on clinical and subclinical kidney function and to investigate the relationship between chronic kidney disease and cardiovascular disease.
Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE) [ACTG #A5361s]
Principal Investigators: Todd Brown, MD, PhD and Kristine Erlandson, MD
Primary Objective: PREPARE is an observational study of muscle strength and function among adults with HIV who are receiving pitavastatin or placebo as part of the REPRIEVE study (A5332) and are also enrolled in the Mechanistic substudy (A5333s).
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
Principal Investigators: Tomas Neilan, MD and Markella Zanni, MD
Primary Objective: This is a study assessing mechanisms of cardiac dysfunction among individuals with HIV on antiretroviral therapy and the effects of pitavastatin on myocardial fibrosis, myocardial steatosis, and cardiac function.
Clonal Hematopoiesis of Indeterminate Potential (CHIP) and Incident Cardiovascular Outcomes
Principal Investigators: Pradeep Natarajan, MD,
Primary Objective: To estimate the prevalence of & characterize risk factors for CHIP in people with HIV, associate CHIP with incident clinical outcomes in people with HIV and discover mechanistic relationships of CHIP with HIV-associated outcomes.
Application Process
We are not currently accepting ancillary study proposals.