Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

NCT02049307 | Completed Phase 2 Results DMC

• 1 other identifier: PCC-007
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Inflammation; Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months

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

  Baseline and 12 months

Secondary Outcomes (1)

• Change in CD4+ Cell Count From Baseline to 12 Months.

  Baseline and 12 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Losartan 100mg daily

Drug: Losartan 100mg daily

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Matching placebo

Interventions

Losartan 100mg daily DRUG

Treatment

Matching placebo DRUG

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead

Study Sites (4)

UCSF

San Francisco, California, 94110, United States

Location

NIH Clinical Center

Bethesda, Maryland, 20892, United States

Location

Allina Health

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• Baker JV, Wolfson J, Collins G, Morse C, Rhame F, Liappis AP, Rizza S, Temesgen Z, Mystakelis H, Deeks S, Neaton J, Schacker T, Sereti I, Tracy RP. Losartan to reduce inflammation and fibrosis endpoints in HIV disease. AIDS. 2021 Mar 15;35(4):575-583. doi: 10.1097/QAD.0000000000002773.

  PMID: 33252490 DERIVED

MeSH Terms

Conditions

Inflammation; Fibrosis

Interventions

Losartan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Jason Baker
• Organization: Hennepin Healthcare Research Institute

baker@umn.edu

612-873-2705

Study Officials

• Jason Baker, M.D.

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Protocol Chair

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: October 16, 2014
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: December 10, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-12

Locations

US (4)