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

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ClinicalTrials.gov Identifier: NCT02049307
Recruitment Status : Active, not recruiting
First Posted : January 30, 2014
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jason Baker, Minneapolis Medical Research Foundation

January 27, 2014
January 30, 2014
March 22, 2018
October 2014
January 2019   (Final data collection date for primary outcome measure)
Interleukin 6 (IL-6) plasma levels [ Time Frame: 12 months ]
Change in plasma IL-6 levels from baseline over 12 months
Same as current
Complete list of historical versions of study NCT02049307 on ClinicalTrials.gov Archive Site
Cluster of differentiation 4 (CD4+) cell count [ Time Frame: 12 months ]
Change in CD4+ cell count from baseline over 12 months
Same as current
Not Provided
Not Provided
 
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Inflammation
  • Fibrosis
  • Drug: Losartan 100mg daily
  • Drug: Matching placebo
  • Active Comparator: Treatment
    Losartan 100mg daily
    Intervention: Drug: Losartan 100mg daily
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
100
February 2019
January 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02049307
PCC-007
Yes
Not Provided
Not Provided
Jason Baker, Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Not Provided
Principal Investigator: Jason Baker, M.D. Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP