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

Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05761509
Collaborator
Merck Sharp & Dohme LLC (Industry)
200
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Single arm

200 subjects exposed to HIV, leading to prescription of 28-day doravirine based post exposure prophylaxis (PEP). The study referred to treatments that are using routinely in the medical care of subjects under PEP. These treatments are the following: Delstrigo®: Fixed-dose combination containing 100mg of doravirine, 245 mg of tenofovir disoproxil and 300 mg of lamivudine, one tablet to be taken orally once daily, with or without food. Pifeltro®: doravirine dosed at 100 mg, on tablet to be taken orally once daily, with or without food, in combination with tenofovir disoproxil/emtricitabine.

Drug: Doravirine
The study treatments will used during 28 days according to the routine care of each investigator center.
Other Names:
  • Delstrigo®
  • Pifeltro®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [3 months]

      Proportion of subjects who complete the total period of treatment (intake during 28 days). The treatment completeness will be defined as follows: no missing treatment intake from D1 to D14, and no more than 2 missing treatment intakes from D15 to D28.

    Secondary Outcome Measures

    1. To evaluate the tolerability of PEP with doravirine. [28 days]

      Number and type of side effects.

    2. To evaluate the prevalence of HIV seroconversion associated with this combination. [3 months]

      Number of subjects with seroconversion.

    3. To compare the adherence of post exposure prophylaxis treatment between Delstrigo® or Pifeltro® [28 days]

      Proportion of subjects who complete the total period of each treatment (intake during 28 days).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    4. Delstrigo® (tenofovir disoproxil, doravirine, lamivudine),

    5. Or Pifeltro® (doravirine) in association with tenofovir disoproxil/emtricitabine.

    6. Participant who can understand, read and speak French.

    7. With or without health insurance.

    8. 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: •

    9. Is not a WOCBP (Women Of Childbearing Potential) OR

    10. 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Karine Lacombe, Pr, Infectious diseases unit / Saint Antoine hospital, Paris (France)
    • Principal Investigator: Roland Tubiana, MD, Infectious diseases unit / La Pitié-Salpêtrière hospital, Paris (France)
    • Principal Investigator: Alain Makinson, Pr, Infectious diseases unit / Montpellier hospital, Montpellier (France)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
    ClinicalTrials.gov Identifier:
    NCT05761509
    Other Study ID Numbers:
    • IMEA 067
    • N° IDRCB: 2022-A02325-38
    First Posted:
    Mar 9, 2023
    Last Update Posted:
    Mar 9, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
    HIV
    PEP
    Doravirine
    HIV exposure
    HIV prevention
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Mar 9, 2023