Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

• Status: Completed
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hennepin Healthcare Research Institute; Minneapolis Medical Research Foundation
• Treatments: Losartan

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)