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Ancillary Studies

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.

For more information on the policies and procedures of the REPRIEVE trial, please read the REPRIEVE Ancillary study policy regarding analyses, timing and content of publications.

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 HIV-infected individuals ages 40-75 sex-based differences in immune activation and statin-induced immunomodulation in relation to clinical cardiovascular disease events.

Evaluate the Effect of Pitavastatin on Kidney Function in HIV-infected Persons

Principal Investigator: Edgar Turner Overton, MD

Primary Objective: To evaluate the effects of pitavastatin on clinically relevant parameters of kidney function among HIV-infected individuals on antiretroviral therapy.

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 HIV-infected adults 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: To assess mechanisms of cardiac dysfunction among HIV-infected individuals on antiretroviral therapy and to assess the effects of pitavastatin on myocardial fibrosis, myocardial steatosis, and cardiac function.

Application Process

We are not currently accepting ancillary study proposals. We will update the website with any changes in the future.

If you are an investigator interested in co-enrollment of REPRIEVE participants in single-site, on-site study with the goal of assessing statin effects on site-specific study endpoints please read the Ancillary Study Charter, Appendix V for more details on this.

We’re currently seeking study participants to take part in REPRIEVE. Please contact us to learn more.

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