NCT03238755

Brief Summary

In this study, investigators plan to test whether statins can preserve and/or improve diastolic function among asymptomatic persons with HIV who are on anti-retroviral therapy. Both myocardial fibrosis and myocardial steatosis are thought to contribute to diastolic dysfunction and eventually overt heart failure in HIV. HIV-positive participants will undergo cardiac MRI/MRS imaging studies for the evaluation of myocardial fibrosis and myocardial steatosis prior to initiation of statin or placebo therapy and then two years after initiation of statin or placebo therapy. Traditional markers of cardiovascular (CVD) risk, systemic immune activation/ inflammation, HIV-specific parameters (i.e. CD4 count), and markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS outcomes.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2026

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

4.9 years

First QC Date

August 1, 2017

Last Update Submit

November 19, 2024

Conditions

HIV Infections

Keywords

HIVDiastolic DysfunctionMyocardial fibrosisStatin

Outcome Measures

Primary Outcomes (1)

  • Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI

    Two years

Secondary Outcomes (1)

  • Diastolic function on Cardiac MRI

    Two years

Other Outcomes (5)

  • Myocardial Inflammation on Cardiac MRI

    Two Years

  • Intramyocardial fat on Cardiac MRI/MRS

    Two Years

  • Diastolic function on Cardiac MRI

    Two Years

  • +2 more other outcomes

Study Arms (2)

Statin group

HIV-infected individuals receiving statin therapy for the duration of the study

Other: Cardiac MRI/MRS

Placebo group

HIV-infected individuals receiving placebo therapy for the duration of the study

Other: Cardiac MRI/MRS

Interventions

Cardiac MRI/MRSOTHER

whole blood, plasma, and serum

Placebo groupStatin group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV-infected subjects on ART from the community

You may qualify if:

  • New enrollment in the REPRIEVE Trial

You may not qualify if:

  • clinical diagnosis of HFpEF or HFrEF, by subject report
  • standard contraindications to MRI procedure based on MRI Patient Procedure Screening Form - including history of severe allergy to gadolinium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Medical Center-Los Angeles

Los Angeles, California, 90073, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UTSW Medical Center

Dallas, Texas, 75235, United States

Location

University of Cape Town

Cape Town, South Africa

Location

Related Publications (1)

  • Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245.

    PMID: 32645158DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, plasma, and serum

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 3, 2017

Study Start

July 31, 2017

Primary Completion

June 22, 2022

Study Completion

April 23, 2026

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)ZA(1)