Inflammation Clinical Trial
— LIFE-HIVOfficial title:
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Verified date | December 2019 |
Source | Hennepin Healthcare Research Institute. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 14, 2018 |
Est. primary completion date | December 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | NIH Clinical Center | Bethesda | Maryland |
United States | Allina Health | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | UCSF | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Hennepin Healthcare Research Institute. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months | Difference between treatment and control IL-6 plasma levels from pre-treatment to on-treatment values | Baseline and 12 months | |
Secondary | Change in CD4+ Cell Count From Baseline to 12 Months. | Change in cluster of differentiation 4 (CD4+) cell count from baseline to 12 months | Baseline and 12 months |
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