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NCT05761509Completed

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
226 (actual)
First submitted
27 Feb 2023
Start date
8 Jun 2023
Primary completion date
30 Jun 2024
Lead sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Diseases
HIV
NCT number
NCT05761509

What you commit to

  • Study type: Observational
  • Participants enrolled: 226
  • From 8 Jun 2023 to the primary completion date, 30 Jun 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.
  • 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.

Other illness

  • Contraindication to Delstrigo® or Pifeltro® or tenofovir disoproxil/emtricitabine: hypersensitivity to active substances or excipients.
  • Subject privated of liberty by judicial or administrative decision or subject under psychiatric care or admitted to a health or social establishment.

Other

  • Viral resistance of the source subject known and unsuitable for the prescription of doravirine
  • Subjects under legal guardianship or unable to express their consent.

Who the study is looking for

  • Age more than 18 years old
  • Exposure to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP)
  • PEP with doravirine:
    • Delstrigo® (tenofovir disoproxil, doravirine, lamivudine),
    • Or Pifeltro® (doravirine) in association with tenofovir disoproxil/emtricitabine.
  • Participant who can understand, read and speak French.
  • With or without health insurance.
  • 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: •
    • Is not a WOCBP (Women Of Childbearing Potential) OR
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Service de maladies infectieuses et tropicales du CHU de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Hôpital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.