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

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

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

• 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.