Status:
COMPLETED
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study was designed to test the hypothesis that treatment of HIV infected subjects with losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will: 1. reverse existing lym...
Detailed Description
This is a randomized, double-blind, placebo-controlled trial of 50 HIV-1 infected individuals on stable ART randomized in a 1:1 ratio to losartan (50 mg orally daily titrated to 100 mg daily) vs place...
Eligibility Criteria
Inclusion
- HIV infected participants:
- Participants must meet all of the following inclusion criteria to participate in this study:
- HIV-1 infected.
- ≥ 18 years of age.
- Baseline peripheral CD4+ T cell count 200-600 cells/mm3 for at least two measures over the 6 months prior to study enrollment.
- ≥ 12 months of stable ART, defined as use of a given drug regimen without disruption lasting ≥ 1 week in the period leading up to study enrollment.
- HIV viral load (VL) \< 50 copies/mL for at least two consecutive measures over the 6 months prior to study enrollment.
- No contraindication to proposed study procedures.
- Women of child-bearing potential must be willing to use a form of effective contraception for the duration of the study. Effective contraception includes hormonal injection, implant or oral medication, IUD, diaphragm, or cervical cap with spermicide. Condoms cannot be used as the sole form of contraception.
Exclusion
- Participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Use of any immunomodulator within the 12 months prior to study enrollment. An immunomodulator for the purposes of this study is defined as a drug known to either diminish or augment a patient's immune system. Examples of these include, but are not limited to, systemic corticosteroids (use of topical steroids will be permitted), TNF-inhibitors, rituximab, cyclophosphamide, abatacept,cyclosporine, azathioprine, 6-mercaptopurine, methotrexate, sulfasalazine, cyclosporine, tacrolimus,sirolimus, and intravenous immune globulin.
- Current use of an ARB or ACEi.
- Current use of rifaximin, fluconazole or lithium given potential for drug interactions with losartan.
- Prior reaction or intolerance to an ARB or ACEi.
- Prior diagnosis of a chronic inflammatory disease with serologic or clinical evidence as diagnosed by a primary care physician or specialist. Examples of these include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome, mixed connective tissue disease, psoriasis, polymyositis, dermatomyositis, vasculitis, sarcoidosis, Wegener's granulomatosis, giant cell arteritis, polyarteritis nodosa, gastrointestinal pemphigoid, eosinophilic colitis, Crohn's disease, ulcerative colitis, autoimmune hepatitis, and hepatitis C.
- Prior diagnosis of a connective tissue disease with genetic, serologic or clinical evidence as diagnosed by a primary care physician or specialist (Marfan's syndrome, Ehlers-Danlos syndrome).
- Baseline blood pressure \< 110/70.
- Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 within 4 weeks of study initiation or history of advanced renal disease.
- AST and/or ALT \> 3 times the upper limit of normal within 4 weeks of study enrollment.
- Potassium \> 5.0 within 4 weeks of study enrollment.
- Pregnancy.
- In women of childbearing age, unwillingness to use birth control for the duration of the study.
- Breast feeding.
- Prior vaccination with an HPV vaccine, including Cervarix (GlaxoSmithKline) or Gardasil (Merck).
- History of hypersensitivity or severe allergic reactions to yeast.
- HIV-uninfected:
- Inclusion Criteria
- Participants must meet all of the following inclusion criteria to participate in this study:
- HIV uninfected.
- ≥ 18 years of age.
- No contraindication to proposed study procedures.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2019
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01852942
Start Date
September 1 2014
End Date
July 16 2019
Last Update
December 11 2020
Active Locations (1)
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1
University of Minnesota, Division of Infectious Diseases
Minneapolis, Minnesota, United States, 55455