# Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

> **NIH NIH R01** · UNIVERSITY OF COLORADO DENVER · 2020 · $540,103

## Abstract

The overall goals of this proposal are to determine whether the HMG-coA reductase inhibitor,
pitavastatin, can attenuate the aging-related decline in physical function in older HIV-infected
persons, and to identify the critical pathways underlying physical function impairment. Our
previous work has demonstrated greater than expected impairments in physical function among
older HIV-infected persons, with an increased risk of falls, hospitalizations, and mortality. The
underlying mechanisms of impaired physical function among HIV-infected persons have not
been elucidated, but our data strongly suggest an association with chronic inflammation. To test
whether this link is casual, we will determine whether pitavastatin, an HMG-CoA reductase
inhibitor with anti-inflammatory effects, will improve physical function, among older HIV-infected
adults on effective ART who are at risk for frailty and its complications. Previous data regarding
the effects of statins on physical function among populations without HIV have been mixed, with
some studies showing a benefit and others showing harm or a null effect. In the setting of this
state of true equipoise, we propose a randomized, double-blind, placebo-controlled trial of
pitavastatin in HIV-infected adults without a statin indication to evaluate whether pitavastatin can
prevent the decline of physical function over four years. We will also determine whether
pitavastatin impacts key pathways thought to underlie physical function impairments, including
elevated systemic inflammation and increased fatty infiltration of muscle. Our proposed study
will leverage the resources of the AIDS Clinical Trials Group and the REPRIEVE trial, a large
NIH-funded, randomized clinical trial evaluating the effects of pitavastatin on cardiovascular
events. The following aims are proposed: 1) To determine the effects of pitavastatin on physical
function, 2) To evaluate mechanistic pathways through which pitavastatin affects physical
function. The results of our study will provide critical information regarding the potential benefit
of statin therapy on physical function versus the potential harm of treatment and burden of an
additional medication in an aging population. The study will also provide key insights into the
longitudinal relationships between inflammation, muscle fat, and physical function. Importantly,
the study will test a novel intervention to reduce functional impairments among aging HIV-
infected persons.

## Key facts

- **NIH application ID:** 9940860
- **Project number:** 5R01AG054366-05
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Kristine Mace Erlandson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $540,103
- **Award type:** 5
- **Project period:** 2016-08-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9940860

## Citation

> US National Institutes of Health, RePORTER application 9940860, Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE) (5R01AG054366-05). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/9940860. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*