Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Inflammation, Fibrosis

In brief

The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

Key facts

Study ID

NCT02049307

Run by

Hennepin Healthcare Research Institute

People needed

108

Starts

2014-10-16

Expected to finish

2018-12-14

Last updated by the study team

2019-12-10

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV infection (verified by previous positive antibody or detectable HIV RNA level)
• Age > 50 years
• Receiving continuous ART for >= 2 years (regimen changes > 6 months prior to enrollment are allowed)
• HIV RNA level < 200 copies/mL for >= 1 year (1 measure >= 200 allowed if also < 1000 and preceded and followed by values < 200 copies/mL)
• Blood CD4+ T-cell count < 600 cells/mm cubed
• Systolic blood pressure > 120 mmHg (mean value if >= 2 measures obtained)
• Estimated glomerular filtration rate (GFR )> 30 mL/min/1.73 m squared
• Do not anticipate starting or stopping statin or aspirin therapy during the study

You may not qualify if…

• Pregnancy or breastfeeding
• A contra-indication to taking an angiotensin receptor blocker (ARB) (e.g., cirrhosis, prior angioedema with angiotensin-converting enzyme inhibitor (ACE-I), or use of drug with potential drug-interaction [e.g., rifaximin])
• A clinical indication for ARB or ACE-I therapy (e.g., cardiovascular disease (CVD), stroke, or diabetes mellitus (DM))
• Current treatment with ARB or medication with overlapping mechanism (e.g., ACE-I or aldosterone antagonist)
• Current treatment with immunomodulatory drugs within the past 6 months
• Current hepatitis treatments (e.g., interferon, ribavirin) within the past 6 months
• Serum potassium > 5.0 millimoles per liter (mmol/L) within 3 months of entry
• Invasive cancer in the prior year or receiving cancer treatment (not including carcinoma-in-situ or basal cell cancer of the skin)
• Cirrhosis or end-stage liver disease
• Rheumatologic or chronic inflammatory disease (e.g., systematic lupus erythematous, psoriasis, rheumatoid arthritis, vasculitis, sarcoidosis, Crohn's disease)

Where it is running

• UCSF — San Francisco, California, United States
• NIH Clinical Center — Bethesda, Maryland, United States
• Allina Health — Minneapolis, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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