Phase 2
Completed N=108
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Source: ClinicalTrials.gov NCT02049307 ↗Enrolled (actual)
108
Serious AEs
9.3%
Results posted
Dec 2019
Primary outcomePrimary: Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months — 0.14; 0.29 pg/mL
Summary
The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months |
0.14; 0.29 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to 12 Months. |
15.1; 6.8 | — |
Eligibility 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 = 1 year (1 measure >= 200 allowed if also 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)
Data sourced from ClinicalTrials.gov (NCT02049307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.