"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"

NCT05761509 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 226

Last updated 2024-10-08

No results posted yet for this study

Summary

The main objective of this observational study is to assess the adherence of post exposure prophylaxis treatment with doravirine (using Delstrigo® or Pifeltro®), prescribed to subjects exposed to HIV according to French national recommendations.

This study will evaluate:

* the percentage of subjects who followed their treatment within the prescribed 28 days,
* the prevalence and type of side effects in subjects on this treatment,
* the occurrence of HIV seroconversion associated with this combination.

Conditions

  • HIV Infections

Interventions

DRUG

Doravirine

The study treatments will used during 28 days according to the routine care of each investigator center.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY
  • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

    lead OTHER

Principal Investigators

  • Karine Lacombe, Pr · Infectious diseases unit / Saint Antoine hospital, Paris (France)

  • Roland Tubiana, MD · Infectious diseases unit / La Pitié-Salpêtrière hospital, Paris (France)

  • Alain Makinson, Pr · Infectious diseases unit / Montpellier hospital, Montpellier (France)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Entities

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 NCT05761509 on ClinicalTrials.gov