How HIV and simvastatin affect outcomes in people with cirrhosis
Official title: Prospective evaluation of outcomes in cirrhosis of different etiologies: impact of HIV infection and simvastatin therapy
Funded at Cleveland Clinic Lerner Com-Cwru · NIH-11169705 · Data updated 2026-11-12
This project looks at whether having HIV and taking simvastatin change health outcomes for adults with cirrhosis from different causes.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Cleveland Clinic Lerner Com-Cwru NIH-funded |
| Lab location | 1 site (Cleveland, United States) |
| Project start | September 23, 2021 |
| Project end | July 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $733,101 |
| NIH project number | 5U01DK130180-05 |
| Project ID | NIH-11169705 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with diagnosed cirrhosis—particularly from alcohol-related liver disease or nonalcoholic fatty liver disease—and people living with HIV would be the best candidates.
✕Less likely to help
People without cirrhosis or those with medical reasons they cannot take statins are unlikely to get direct benefit from this project.
What this research studies
If you have cirrhosis, researchers will follow you over time to see how your disease progresses depending on its cause (for example, alcohol-related or fatty liver) and whether you have HIV. The project will also test whether simvastatin affects muscle loss, physical frailty, liver complications, and liver cancer risk. Study visits will include clinical exams, muscle and strength measurements, and collection of blood and stool samples to study the gut microbiome and metabolites. All participants will be tracked for hospitalizations, liver decompensation, and other important outcomes.
Why it matters
Potential benefit: If successful, this work could help slow liver damage, reduce frailty and muscle loss, and lower the risk of complications like decompensation or liver cancer.
How similar studies have gone: Previous smaller studies and database analyses have suggested statins and microbiome changes may help liver outcomes, but a large prospective effort combining cirrhosis cause, HIV status, and sarcopenia/frailty outcomes is relatively new.
Where this research is happening
-
Cleveland Clinic Lerner Com-Cwru
Cleveland, United States Active
Researchers
- Principal investigator: Dasarathy, Srinivasan — Cleveland Clinic Lerner Com-Cwru
- Study coordinator: Dasarathy, Srinivasan
Related research
Other NIH-funded projects on the same topics.
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Outcomes in cirrhosis from different causes and the role of HIV and simvastatin
This study looks at how cirrhosis from alcohol, HIV, and other causes affects patients and whether simvastatin can influence outcomes.
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Evaluating outcomes in cirrhosis and the effects of HIV and simvastatin
This study is looking at how simvastatin might help people with liver disease from cirrhosis, especially those who also have HIV, by tracking their health and any changes in their strength and overall well-being over time.
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Evaluating outcomes in cirrhosis related to HIV and simvastatin treatment
This study is looking at how simvastatin treatment affects people with cirrhosis who also have HIV, to see how it influences their liver health and related issues like muscle loss and weakness, so we can better understand how to help them feel better and improve their condition.
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Understanding how genetic changes in blood cells relate to heart disease in people with HIV
A study will look at how age-related blood cell mutations and large chromosomal changes might contribute to heart disease risk in people living with HIV.
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Cardiac health and protein markers in kids with perinatal HIV exposure or infection
A study from Duke aims to understand heart health and protein biomarkers in children who were exposed to or infected with HIV at birth, especially in sub-Saharan Africa.
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This project studies how HBV-specific B and T cell responses relate to curing hepatitis B in people with and without HIV.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.