HIV InfectionsNCT03238755
Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
An observational study of HIV Infections, run by Massachusetts General Hospital at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cardiac MRI/MRS
- How many people
- 129 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 31 Jul 2017to 23 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected subjects on ART from the community
Who may be able to join
- New enrollment in the REPRIEVE Trial
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
UTSW Medical Center
Dallas, Texas, 75235
VA Medical Center-Los Angeles
Los Angeles, California, 90073
About this study
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.
- Conditions
- HIV Infections
- Being tested
- Cardiac MRI/MRS
- Keywords
- HIV, Diastolic Dysfunction, Myocardial fibrosis, Statin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI/MRSOther
whole blood, plasma, and serum
| Study group | Role | What they receive |
|---|---|---|
| Statin group | HIV-infected individuals receiving statin therapy for the duration of the study Receives: Other: Cardiac MRI/MRS | |
| Placebo group | HIV-infected individuals receiving placebo therapy for the duration of the study Receives: Other: Cardiac MRI/MRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI
Measured: Two years
Secondary outcomes (1)
Diastolic function on Cardiac MRI
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start31 Jul 2017
- Primary completion22 Jun 2022
- Study completion23 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Tomas G. Neilan, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238755
- Sponsor's protocol ID
- 2016P001999
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2017
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 32645158
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Cardiac Dysfunction in HIV and the Effect of Statins: A Cardiac MRI Study
- ClinicalTrials.gov ID
- NCT03238755
- Acronym / sponsor ID
- 2016P001999
- Conditions
- HIV Infections
- Keywords
- HIV, Diastolic Dysfunction, Myocardial fibrosis, Statin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 23 Feb 2028 (estimated)
- First posted
- 3 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin group | – | Other: Cardiac MRI/MRSHIV-infected individuals receiving statin therapy for the duration of the study |
| Placebo group | – | Other: Cardiac MRI/MRSHIV-infected individuals receiving placebo therapy for the duration of the study |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected subjects on ART from the community
Key inclusion criteria (1 listed)
- New enrollment in the REPRIEVE Trial
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRI/MRSwhole blood, plasma, and serum | Other | Placebo group, Statin group |
Primary outcome
Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI
Time frame: Two years
1 secondary outcome
Diastolic function on Cardiac MRI
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 32645158Neilan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Massachusetts General Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular Volume (ECV), a measure of myocardial fibrosis on Cardiac MRI (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03238755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.