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HIV InfectionsDORASPEPNCT05761509

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

An observational study of HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Doravirine
Type of treatment
Pill or oral medicine
How many people
226 participants
Where
3 sitesFrance
Study dates
8 Jun 2023to 30 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult subjects exposed to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP) with doravirine.

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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 doravirine
  • 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.
  • 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.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service de maladies infectieuses et tropicales du CHU de Montpellier

    Montpellier, 34295

  • Hopital Saint Antoine

    Paris, 75012

  • Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière

    Paris, 75013

Other trials in France

About this study

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.
Read the 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.
Conditions
HIV Infections
Being tested
Doravirine
Keywords
HIV, PEP, Doravirine, HIV exposure, HIV prevention
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoravirineDrug

    Also called Delstrigo®, Pifeltro®

    The study treatments will used during 28 days according to the routine care of each investigator center.

Study groups in NCT05761509
Study groupRoleWhat they receive
Single arm200 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.
Receives: Drug: Doravirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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.

    Measured: 3 months

Secondary outcomes (3)

  1. To evaluate the tolerability of PEP with doravirine.

    Number and type of side effects.

    Measured: 28 days

  2. To evaluate the prevalence of HIV seroconversion associated with this combination.

    Number of subjects with seroconversion.

    Measured: 3 months

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

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

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start8 Jun 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05761509
Sponsor's protocol ID
IMEA 067
Other IDs
N° IDRCB: 2022-A02325-38
Acronym
DORASPEP
Status last verified
Apr 2023
First submitted
27 Feb 2023
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will be decided later by the scientific committee.

Publications

  • Rapport Morlat : Prise en charge des accidents d'exposition sexuelle et au sang (AES) chez l'adulte et l'enfant (septembre 2017) https://cns.sante.fr/wp-content/uploads/2017/10/experts-vih_aes.pdf.

  • Assoumou L, Bocket L, Pallier C, Grude M, Ait-Namane R, Izopet J, Raymond S, Charpentier C, Visseaux B, Wirden M, Trabaud MA, Le Guillou-Guillemette H, Allaoui C, Henquell C, Krivine A, Dos Santos G, Delamare C, Bouvier-Alias M, Montes B, Ferre V, De Monte A, Signori-Schmuck A, Maillard A, Morand-Joubert L, Tumiotto C, Fafi-Kremer S, Amiel C, Barin F, Marque-Juillet S, Courdavault L, Vallet S, Beby-Defaux A, de Rougemont A, Fenaux H, Avettand-Fenoel V, Allardet-Servent A, Plantier JC, Peytavin G, Calvez V, Chaix ML, Descamps D; ANRS AC-43 Resistance Study Group. Stable prevalence of transmitted drug resistance mutations and increased circulation of non-B subtypes in antiretroviral-naive chronically HIV-infected patients in 2015/2016 in France. J Antimicrob Chemother. 2019 May 1;74(5):1417-1424. doi: 10.1093/jac/dkz011.

    PubMed 30753724

  • Pham HT, Xiao MA, Principe MA, Wong A, Mesplede T. Pharmaceutical, clinical, and resistance information on doravirine, a novel non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1 infection. Drugs Context. 2020 Mar 3;9:2019-11-4. doi: 10.7573/dic.2019-11-4. eCollection 2020.

    PubMed 32180823

  • Valin N, Fonquernie L, Daguenel A, Campa P, Anthony T, Guiguet M, Girard PM, Meyohas MC. Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis. BMC Infect Dis. 2016 Nov 29;16(1):718. doi: 10.1186/s12879-016-2056-3.

    PubMed 27894270

  • Inciarte A, Leal L, Gonzalez E, Leon A, Lucero C, Mallolas J, Torres B, Laguno M, Rojas J, Martinez-Rebollar M, Gonzalez-Cordon A, Cruceta A, Arnaiz JA, Gatell JM, Garcia F; STRIBPEP Study Group. Tenofovir disoproxil fumarate/emtricitabine plus ritonavir-boosted lopinavir or cobicistat-boosted elvitegravir as a single-tablet regimen for HIV post-exposure prophylaxis. J Antimicrob Chemother. 2017 Oct 1;72(10):2857-2861. doi: 10.1093/jac/dkx246.

    PubMed 29091217

  • Gantner P, Hessamfar M, Souala MF, Valin N, Simon A, Ajana F, Bouvet E, Rouveix E, Cotte L, Bani-Sadr F, Hustache-Mathieu L, Lebrette MG, Truchetet F, Galempoix JM, Piroth L, Pellissier G, Muret P, Rey D; E/C/F/TAF PEP Study Group. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis. 2020 Feb 14;70(5):943-946. doi: 10.1093/cid/ciz577.

    PubMed 31804669

  • Eviplera: Product information from the European Medecines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/eviplera

  • Genvoya: Product information from the European Medecines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/genvoya

  • Pifeltro: Product information from the European Medecines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/pifeltro

  • Delstrigo: Product information from the European Medecines Agency: https://www.ema.europa.eu/en/medicines/human/EPAR/delstrigo#product-information-section

  • HIV drugs interactions, University of Liverpool: http://www.hiv-druginteractions.org

  • Scheibe K, Urbanska A, Jakubowski P, Hlebowicz M, Bociaga-Jasik M, Raczynska A, Szymczak A, Szetela B, Lojewski W, Parczewski M. Low prevalence of doravirine-associated resistance mutations among polish human immunodeficiency-1 (HIV-1)-infected patients. Antivir Ther. 2021 May;26(3-5):69-78. doi: 10.1177/13596535211043044. Epub 2021 Oct 20.

    PubMed 35485331

  • Asante-Appiah E, Lai J, Wan H, Yang D, Martin EA, Sklar P, Hazuda D, Petropoulos CJ, Walworth C, Grobler JA. Impact of HIV-1 Resistance-Associated Mutations on Susceptibility to Doravirine: Analysis of Real-World Clinical Isolates. Antimicrob Agents Chemother. 2021 Nov 17;65(12):e0121621. doi: 10.1128/AAC.01216-21. Epub 2021 Sep 27.

    PubMed 34570651

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05761509, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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