Clinical trial NCT05761509: "Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"
Official title: "Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
PEP
Doravirine
HIV exposure
HIV prevention
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-03-09
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects exposed to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP) with doravirine.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years old
2. Exposure to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP)
3. PEP with doravirine:

   1. Delstrigo® (tenofovir disoproxil, doravirine, lamivudine),
   2. Or Pifeltro® (doravirine) in association with tenofovir disoproxil/emtricitabine.
4. Participant who can understand, read and speak French.
5. With or without health insurance.
6. Cisgender female and Female to Male transgender participants are eligible to participate if they are not pregnant or breastfeeding, and at least one of the following conditions applies: •

   1. Is not a WOCBP (Women Of Childbearing Potential) OR
   2. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), or be abstinent as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the treatment period and for at least 8 weeks after the last dose. The investigator should evaluate the potential for contraceptive method failure (i.e., non compliance, recently initiated) in relationship to the first dose of PEP treatment.

A WOCBP must have a negative pregnancy test (urine or serum) before inclusion in the study. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant should not be included in the study if the serum pregnancy result is positive.

Exclusion Criteria:

1. Contraindication to Delstrigo® or Pifeltro® or tenofovir disoproxil/emtricitabine: hypersensitivity to active substances or excipients.
2. Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.
3. Viral resistance of the source subject known and unsuitable for the prescription of doravirine
4. Simultaneous participation in another clinical trial with an experimental treatment or any intervention, which may have impact/change onto the PEP treatments or within an exclusion period of a previous clinical trial at screening.
5. Subjects under legal guardianship or unable to express their consent.
6. Subject privated of liberty by judicial or administrative decision or subject under psychiatric care or admitted to a health or social establishment.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: To evaluate the tolerability of PEP with doravirine.
timeFrame: 28 days
measure: To evaluate the prevalence of HIV seroconversion associated with this combination.
timeFrame: 3 months
measure: To compare the adherence of post exposure prophylaxis treatment between Delstrigo® or Pifeltro®
timeFrame: 28 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Service de maladies infectieuses et tropicales du CHU de Montpellier
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière
Study officials:
affiliation: Infectious diseases unit / Saint Antoine hospital, Paris (France)
name: Karine Lacombe, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious diseases unit / La Pitié-Salpêtrière hospital, Paris (France)
name: Roland Tubiana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious diseases unit / Montpellier hospital, Montpellier (France)
name: Alain Makinson, Pr
role: PRINCIPAL_INVESTIGATOR
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