Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
NCT ID: NCT02049307
Last Updated: 2019-12-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2014-10-16
2018-12-14
Brief Summary
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Detailed Description
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The potential benefits of losartan (100mg daily) will be studied among HIV positive individuals over age 50 years whose CD4 counts remain ≤600 cells/mm3. Participants (n=110, 55 per group) will be randomized to receive losartan or matching placebo daily. After randomization, participants will start losartan (or placebo) at a dose of 50mg once daily, increasing to 100mg once daily at the 2-week study visit pending results of a week 2 toxicity lab evaluation (see 2.4 below for criteria). Following month 1, participants will return for follow-up study visit procedures at months 3, 6, 9, and 12.
Changes from baseline in measures of inflammation, immune activation, immune recovery and fibrosis within lymphatic tissues will be studied. The primary outcome will be the average of IL-6 levels over 12 months, and the main secondary outcome will be change in CD4 count in blood over 12 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
Losartan 100mg daily
Losartan 100mg daily
Placebo
Matching placebo
Matching placebo
Interventions
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Losartan 100mg daily
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
ALL
No
Sponsors
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Hennepin Healthcare Research Institute
OTHER
Responsible Party
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Jason Baker
Protocol Chair
Principal Investigators
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Jason Baker, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute
Locations
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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
Countries
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References
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Baker JV, Wolfson J, Collins G, Morse C, Rhame F, Liappis AP, Rizza S, Temesgen Z, Mystakelis H, Deeks S, Neaton J, Schacker T, Sereti I, Tracy RP. Losartan to reduce inflammation and fibrosis endpoints in HIV disease. AIDS. 2021 Mar 15;35(4):575-583. doi: 10.1097/QAD.0000000000002773.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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PCC-007
Identifier Type: -
Identifier Source: org_study_id