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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 Jason Baker, Minneapolis Medical Research Foundation
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation Identifier:
First received: January 27, 2014
Last updated: September 12, 2016
Last verified: September 2016
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: Quadruple (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 Jason Baker, 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


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT02049307

Contact: Jason Baker, M.D. 612-873-2700

United States, California
UCSF Recruiting
San Francisco, California, United States, 94110
Contact: Marian Kerbleski, RN    415-476-4082   
Contact: Sophie Lyons   
Principal Investigator: Hiroyu Hatano, MD         
United States, Maryland
NIH Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Cheryl Chairez, RN    301-496-1031   
Principal Investigator: Caryn Morse, MD         
United States, Minnesota
Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Rita Bouley, RN    612-863-7046   
Contact: Deb Wood, RN    612-863-7046   
Principal Investigator: Frank Rhame, MD         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Martha Cornell, RN    612-873-2011   
Contact: Andrea Dolan, BS    612-873-7678   
Principal Investigator: Jason Baker, MD, MS         
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Principal Investigator: Jason Baker, M.D. Minneapolis Medical Research Foundation
  More Information

Responsible Party: Jason Baker, Protocol Chair, Minneapolis Medical Research Foundation 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:
Pathologic Processes
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017