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NCT02049307: LIFE-HIV

Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

Completed Phase 2 Results posted Last updated 10 December 2019
What this trial tests

Phase 2 trial testing Losartan 100mg daily in Inflammation in 108 participants. Completed in 14 December 2018.

Timeline
16 October 2014
Primary endpoint
14 December 2018
14 December 2018

Quick facts

Lead sponsorHennepin Healthcare Research Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment108
Start date16 October 2014
Primary completion14 December 2018
Estimated completion14 December 2018
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hennepin Healthcare Research Institute

Who can join

50 and older, any sex, with Inflammation or Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months Primary · Baseline and 12 months

Difference between treatment and control IL-6 plasma levels from pre-treatment to on-treatment values

GroupValue95% CI
Treatment0.14± 1.22
Placebo0.29± 1.25
Change in CD4+ Cell Count From Baseline to 12 Months. Secondary · Baseline and 12 months

Change in cluster of differentiation 4 (CD4+) cell count from baseline to 12 months

GroupValue95% CI
Treatment (Losartan)15.1± 7.6
Placebo6.8± 7.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Losartan)
Serious: 6/52 (12%)
Deaths: 0/52
Placebo
Serious: 4/56 (7%)
Deaths: 0/56

Serious adverse events (10 terms)

ReactionSystemTreatment (Losartan)Placebo
Mesenteric Vein ThrombosisVascular disorders——
Ischaemic StrokeVascular disorders——
Hypoglossal Nerve DisorderVascular disorders——
CellulitisSkin and subcutaneous tissue disorders——
Gastrointestinal HemorrhageGastrointestinal disorders——
SepsisInfections and infestations——
Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders——
PneumoniaInfections and infestations——
Intestinal ObstructionGastrointestinal disorders——
Wound DehiscenceSkin and subcutaneous tissue disorders——
Other adverse events (22 terms — click to expand)

ReactionSystemTreatment (Losartan)Placebo
DizzinessNervous system disorders——
FatigueGeneral disorders——
MalaiseGeneral disorders——
Aspartate Aminotransferase IncreasedGastrointestinal disorders——
Chest PainCardiac disorders——
DysgeusiaNervous system disorders——
FallGeneral disorders——
HypotensionVascular disorders——
InsomniaGeneral disorders——
Ligament SprainMusculoskeletal and connective tissue disorders——
Musculoskeletal PainMusculoskeletal and connective tissue disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
PneumoniaRespiratory, thoracic and mediastinal disorders——
Skin AbrasionSkin and subcutaneous tissue disorders——
SomnambulismNervous system disorders——
VertigoNervous system disorders——
Abdominal PainGastrointestinal disorders——
Alanine Aminotransferase IncreasedGastrointestinal disorders——
DeafnessEar and labyrinth disorders——
LeukopeniaImmune system disorders——
Diabetes Mellitus Type 2Endocrine disorders——
DyspnoeaRespiratory, thoracic and mediastinal disorders——

Most-reported serious reactions: Mesenteric Vein Thrombosis, Ischaemic Stroke, Hypoglossal Nerve Disorder, Cellulitis, Gastrointestinal Hemorrhage, Sepsis, Chronic Obstructive Pulmonary Disease, Pneumonia.

Data from ClinicalTrials.gov NCT02049307 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the potential effectiveness of losartan (100mg daily) for reducing inflammation and improving immune recovery.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Inflammation, immune activation, and cardiovascular disease in HIV.
    Nou E, Lo J, Grinspoon SK. · · 2016 · cited 181× · PMID 27058351 · DOI 10.1097/qad.0000000000001109
  2. Immune activation and cardiovascular disease in chronic HIV infection.
    Longenecker CT, Sullivan C, Baker JV. · · 2016 · cited 85× · PMID 26599166 · DOI 10.1097/coh.0000000000000227
  3. Losartan to reduce inflammation and fibrosis endpoints in HIV disease.
    Baker JV, Wolfson J, Collins G, Morse C, et al · · 2021 · cited 14× · PMID 33252490 · DOI 10.1097/qad.0000000000002773
  4. Short Communication: A Pilot Study of the Effects of Losartan Versus Placebo on Pneumoproteins in HIV: A Secondary Analysis of a Randomized Double Blind Study.
    MacDonald DM, Collins G, Wendt CH, Wolfson J, et al · · 2022 · cited 5× · PMID 33749317 · DOI 10.1089/aid.2020.0285
  5. Pharmacokinetic approaches to standardize antiviral exposure in cerebrospinal fluid.
    Avedissian SN, Mu Y, McCarthy C, Bosch RJ, et al · · 2025 · cited 1× · PMID 40152440 · DOI 10.1002/phar.70013
  6. Pulmonary Immunocompromise in Human Immunodeficiency Virus Disease.
    Attia EF, Maleche-Obimbo E, Ellington LE, North CM. · · 2025 · cited 1× · PMID 39890288 · DOI 10.1016/j.ccm.2024.10.014

Verify or expand the search:

Other recruiting trials for Inflammation

Currently open trials in the same condition.

Other Hennepin Healthcare Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02049307.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing