NCT05761509

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 226 (actual)
• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study visits are those routinely performed in the standard care of the subjects using PEP and are the following: Visit 1 (between day 1 to day 8 after PEP treatment initiation): * Subject information and inclusion in the study, * Pregnancy test (urine or serum) for women of childbearing potential (WOCBP) * Delivery of a follow-up subject diary (daily information about PEP treatment intake, concomitant treatments and potential side effects/adverse events) Visit 2 (From 42 days to 90 days after PEP treatment initiation) * Treatment observance (PEP), * Return of the follow-up subject diary, * Check of the follow-up subject diary completion, * Keep a copy of the HIV serology and/or viral load results in the medical file.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Doravirine	The study treatments will used during 28 days according to the routine care of each investigator center.

Timeline

• Start date: 2023-06-08
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-03-09
• Last updated: 2024-10-08

Locations

3 sites across 1 country: France