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A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.

NCT04840199 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-03-04

Study results available
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Summary

This was an open-label, controlled study, conducted at US sites to evaluate the anti-inflammatory effectiveness of the study drug letermovir in adults with HIV and asymptomatic cytomegalovirus (CMV) who were on antiretroviral therapy (ART)-mediated suppression. Participants were randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks.

The primary hypothesis of this study was that letermovir would cause a greater reduction in plasma soluble receptor for tumor necrosis factor type II (sTNFRII) levels than no anti-CMV treatment at weeks 46/48.

Conditions

  • HIV Infections
  • Cytomegalovirus
  • CMV

Interventions

DRUG

Letermovir Oral Tablet

480 mg administered orally once daily with or without food

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Peter Hunt, MD · University of California, San Francisco, HIV/AIDS CRS

  • Sara Gianella, MD · University of California, San Diego, AntiViral Research Center CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840199 on ClinicalTrials.gov