ClinicalTrials.gov

History of Changes for Study: NCT03070223
PREPARE (A5361s) Substudy of REPRIEVE (A5332) (PREPARE)
Latest version (submitted December 7, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 2, 2017 None (earliest Version on record)
2 May 1, 2017 Contacts/Locations and Study Status
3 November 29, 2017 Study Status and Contacts/Locations
4 January 8, 2018 Study Status and Contacts/Locations
5 February 21, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 September 18, 2018 Study Status
7 January 4, 2019 Study Status
8 November 25, 2019 Study Status
9 March 4, 2020 Study Status
10 October 28, 2020 Study Status
11 December 7, 2022 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03070223
Submitted Date:  March 2, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: ACTG A5361s
Brief Title: PREPARE (A5361s) Substudy of REPRIEVE (A5332) (PREPARE)
Official Title: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)
Secondary IDs: UM1AI068636 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Recruiting
Study Start: February 28, 2017
Primary Completion: February 28, 2023 [Anticipated]
Study Completion: February 28, 2023 [Anticipated]
First Submitted: February 22, 2017
First Submitted that
Met QC Criteria:
March 2, 2017
First Posted: March 3, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 2, 2017
Last Update Posted: March 3, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AIDS Clinical Trials Group
Responsible Party: Sponsor
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Aging (NIA)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Aging with HIV may be related to an earlier development of frailty (weakness) or disability, including difficulties in tests of strength or walking speed. Few treatments have been shown to prevent or slow these impairments in people with or without HIV. Some studies have suggested that the class of drugs called statins (for example, pitavastatin) might be helpful in slowing frailty or disability. This might happen by decreasing fat within the muscle or by decreasing inflammation markers (substances in the blood that determine how the body reacts to infection or irritation) in the blood. Other studies have shown that statins increase the risk of muscle aches and pains. This substudy is being done to determine the impact of the drug pitavastatin on muscle.
Detailed Description:

A5361s is a prospective study to determine the effects of pitavastatin on physical function. The study will enroll participants enrolled in both REPRIEVE (A5332) and its mechanistic sub-study A5333s or in REPRIEVE (A5332) alone and follow them for 48 months after entry to REPRIEVE (A5332). Treatment groups (pitavastatin vs placebo) will be defined according to randomization in REPRIEVE (A5332). No intervention will be provided in this sub-study.

Study visits are scheduled at PREPARE (A5361s) entry and at months 12, 24, 36 and 48 after REPRIEVE (A5332) entry. Each study visit will include evaluation of physical function, frailty and self-reported physical activity and sedentary time. In addition, demographic and clinical data, laboratory specimens and CT scans collected as part of the main study REPRIEVE (A5332) or its mechanistic sub-study A5333s will be used.

Open or close this module Conditions
Conditions: HIV-1 Infection
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 600 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Experimental: Pitavastatin
Participants who receive pitavastatin in the main study REPRIEVE (A5332).
Drug: Pitavastatin
One tablet (4 mg) taken once daily, orally with or without food
Placebo Comparator: Placebo
Participants who receive placebo for pitavastatin in the main study REPRIEVE (A5332).
Drug: Placebos
One tablet taken once daily, orally with or without food
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of change in chair rise rate
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Participants will be asked to perform 10 chair stands. Chair rise rate will be calculated as time to perform chair stands divided by the number of chair stands performed. . Repeated measures analysis will be used to model chair rise rate over time and estimate rate of change.
2. Rate of change in Inflammatory Index Score (IIS)
[ Time Frame: Baseline and 12 months ]

The IIS score will be calculated as 1/3 log [interleukin-6 (IL-6)] + 2/3 log [soluble tumor necrosis factor receptor 1 (sTNFR-1)] using samples collected as part of the main study REPRIEVE (A5332).
3. Rate of change in paraspinal muscle density
[ Time Frame: Baseline and 24 months ]

Paraspinal muscle density will be measured in Hounsfield units (HU) from the CT scans performed as part of A5333s, the mechanistic sub-study of REPRIEVE (A5332).
Secondary Outcome Measures:
1. Physical function outcome measure: Grip strength
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Participant's grip strength in the dominant hand measured by Jamar Hydraulic Hand Dynamometer.
2. Physical function outcome measure: Gait speed
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Participant's gait speed evaluated by time to complete 4-meter walk.
3. Physical function outcome measure: Balance
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Balance evaluated by participant's ability to hold one leg stand for 30 seconds.
4. Physical function outcome measure: Physical function deficit
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Physical function deficit defined as composite Short Physical Performance Battery (SPPB, consisting of repeat chair stand, balance, grip strength and gait speed tests) score <=10.
5. Physical function outcome measure: Self-reported physical activity
[ Time Frame: Baseline and months 12, 24, 36 and 48 ]

Self-reported physical activity evaluated by the questionnaire "Rapid Eating and Activity Assessment for Patients" (REAP).
6. Mechanistic outcome measure: Serum concentrations of biomarkers
[ Time Frame: Baseline and month 12 ]

Select biomarkers including each individual biomarker of the IIS (IL-6, sTNFR-1) as well as other biomarkers implicated in the pathogenesis of physical function impairment or those that may mediate the effects of statins on systemic inflammation. The specific list of biomarkers of interest will be finalized closer to the time of analysis, incorporating the developments in the field over the next few years.
7. Mechanistic outcome measure: Shoulder muscle density
[ Time Frame: Baseline and month 24 ]

Shoulder muscle density measured in Hounsfield units (HU) from the CT scans performed as part of A5333s, the mechanistic sub-study of REPRIEVE (A5332).
8. Mechanistic outcome measure: Upper back muscle density
[ Time Frame: Baseline and month 24 ]

Upper back muscle density measured in Hounsfield units (HU) from the CT scans performed as part of A5333s, the mechanistic sub-study of REPRIEVE (A5332).
9. Mechanistic outcome measure: Paraspinal muscle volume
[ Time Frame: Baseline and month 24 ]

Paraspinal muscle volume (area) measured from the CT scans performed as part of A5333s, the mechanistic sub-study of REPRIEVE (A5332).
10. Mechanistic outcome measure: Trunk muscle volume
[ Time Frame: Baseline and month 24 ]

Trunk muscle volume (area) measured from the CT scans performed as part of A5333s, the mechanistic sub-study of REPRIEVE (A5332).
Open or close this module Eligibility
Study Population: It is desired that a substantial proportion of participants are enrolled in A5333s.
Sampling Method: Probability Sample
Minimum Age: 40 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Ambulatory participants enrolled in both REPRIEVE (A5332) and its Mechanistic Substudy (A5333s) or ambulatory participants who are newly enrolling into REPRIEVE (A5332) at A5333s ACTG sites.

Exclusion Criteria:

  • Inability to ambulate independently (use of a cane or a walker is permitted) or rise from a chair without assistance.
Open or close this module Contacts/Locations
Central Contact Person: Linda Boone, BS
Telephone: 3016283363
Email: lboone@s-3.com
Study Officials: Todd Brown, MD, PhD
Study Chair
Johns Hopkins University
Kristine Erlandson, MD
Study Chair
University of Colorado, Denver
Locations: United States, California
601 University of California, Los Angeles CARE Center CRS
[Recruiting]
Los Angeles, California, United States, 90035
Contact:Contact: Arezou Sadighi Akha 310-206-6414
Contact:Principal Investigator: Raphael Landovitz, MD
Ucsf Aids Crs (801)
[Recruiting]
San Francisco, California, United States, 94110
Contact:Contact: Jay Dwyer, RN, ACRN 415-476-4082 Ext. 353 jdwyer@php.ucsf.edu
Contact:Principal Investigator: Diane V. Havlir, MD
United States, Illinois
Northwestern University CRS (2701)
[Recruiting]
Chicago, Illinois, United States, 60611
Contact:Contact: Baiba Berzins, MPH 312-695-5012 baiba@northwestern.edu
Contact:Principal Investigator: Babafemi Taiwo, MBBS, MD
United States, Missouri
Washington University CRS (2101)
[Recruiting]
St. Louis, Missouri, United States, 63110
Contact:Contact: Michael Klebert, RNC, PhD, ANP 1-314-747-1098 mklebert@im.wustl.edu
Contact:Principal Investigator: David Clifford, MD
United States, North Carolina
Unc Aids Crs (3201)
[Recruiting]
Chapel Hill, North Carolina, United States, 27516
Contact:Contact: Susan Pedersen, RN, BSN 919-966-6713 spederse@med.unc.edu
Contact:Principal Investigator: David Wohl, MD
United States, Ohio
Case CRS (2501)
[Recruiting]
Cleveland, Ohio, United States, 44106
Contact:Contact: Jane Baum, RN 216-844-2546 baum.jane@clevelandactu.org
Contact:Principal Investigator: Benigno Rodriguez, MD
United States, Tennessee
Vanderbilt Therapeutics CRS (3652)
[Recruiting]
Nashville, Tennessee, United States, 37204
Contact:Contact: Beverly Woodward, RN, MSN 615-936-8516 beverly.o.woodward@vanderbilt.edu
Contact:Principal Investigator: David Haas, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services