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Not Yet Recruiting NCT05761509

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

Conditions: HIV Infections

Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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.

Eligibility Criteria

Inclusion Criteria:Age more than 18 years oldExposure 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) ORIs 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:Contraindication to Delstrigo® or Pifeltro® or tenofovir disoproxil/emtricitabine: hypersensitivity to active substances or excipients.Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.Viral resistance of the source subject known and unsuitable for the prescription of doravirineSimultaneous 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.Subjects under legal guardianship or unable to express their consent.Subject privated of liberty by judicial or administrative decision or subject under psychiatric care or admitted to a health or social establishment.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05761509). StuddyBuddy aggregates publicly available trial information.