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

April 18, 2024 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34295
        • Service de maladies infectieuses et tropicales du CHU de Montpellier
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75013
        • Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the tolerability of PEP with doravirine.
Time Frame: 28 days
Number and type of side effects.
28 days
To evaluate the prevalence of HIV seroconversion associated with this combination.
Time Frame: 3 months
Number of subjects with seroconversion.
3 months
To compare the adherence of post exposure prophylaxis treatment between Delstrigo® or Pifeltro®
Time Frame: 28 days
Proportion of subjects who complete the total period of each treatment (intake during 28 days).
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Collaborators

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 067
  • N° IDRCB: 2022-A02325-38 (Other Identifier: ANSM, France)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will be decided later by the scientific committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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