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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02049307
First Posted: January 30, 2014
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation
  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: 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


Enrollment: 108
Study Start Date: October 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2018 (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

Detailed Description:

Our general goal is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery, given the potential for these treatment effects to reduce risk for long-term non-AIDS-defining complications among older HIV positive participants. Prior to conducting a clinical outcome trial, candidate treatments must be studied among HIV positive patients given the unique pathogenesis driving inflammation and disease risk.

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049307


Locations
United States, California
UCSF
San Francisco, California, United States, 94110
United States, Maryland
NIH Clinical Center
Bethesda, Maryland, United States, 20892
United States, Minnesota
Allina Health
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55417
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
First Submitted: January 27, 2014
First Posted: January 30, 2014
Last Update Posted: September 15, 2017
Last Verified: September 2017

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