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Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial (LIFE-HIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Minneapolis Medical Research Foundation
Sponsor:
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT02049307
First received: January 27, 2014
Last updated: September 12, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

Condition Intervention Phase
Inflammation
Fibrosis
Drug: Losartan 100mg daily
Drug: Matching placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • Interleukin 6 (IL-6) plasma levels [ Time Frame: 12 months ]
    Change in plasma IL-6 levels from baseline over 12 months


Secondary Outcome Measures:
  • Cluster of differentiation 4 (CD4+) cell count [ Time Frame: 12 months ]
    Change in CD4+ cell count from baseline over 12 months


Estimated Enrollment: 100
Study Start Date: October 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
Losartan 100mg daily
Drug: Losartan 100mg daily
Placebo Comparator: Placebo
Matching placebo
Drug: Matching placebo

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049307

Contacts
Contact: Jason Baker, M.D. 612-873-2700 baker@umn.edu

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94110
Contact: Marian Kerbleski, RN    415-476-4082    kerbleskim@php.ucsf.edu   
Contact: Sophie Lyons       LyonsS@php.ucsf.edu   
Principal Investigator: Hiroyu Hatano, MD         
United States, Maryland
NIH Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Cheryl Chairez, RN    301-496-1031    chairezc@niaid.nih.gov   
Principal Investigator: Caryn Morse, MD         
United States, Minnesota
Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Rita Bouley, RN    612-863-7046    Rita.Bouley@allina.com   
Contact: Deb Wood, RN    612-863-7046    deborah.wood@allina.com   
Principal Investigator: Frank Rhame, MD         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Martha Cornell, RN    612-873-2011    martha.cornell@hcmed.org   
Contact: Andrea Dolan, BS    612-873-7678    andrea.dolan@hcmed.org   
Principal Investigator: Jason Baker, MD, MS         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: Jason Baker, M.D. Minneapolis Medical Research Foundation
  More Information

Responsible Party: Jason Baker, Protocol Chair, Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02049307     History of Changes
Other Study ID Numbers: PCC-007
Study First Received: January 27, 2014
Last Updated: September 12, 2016

Additional relevant MeSH terms:
Fibrosis
Inflammation
Pathologic Processes
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 26, 2017