NCT05761509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

October 8, 2024

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

February 27, 2023

Last Update Submit

October 3, 2024

Conditions

HIV Infections

Keywords

HIVPEPDoravirineHIV exposureHIV prevention

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (3)

  • To evaluate the tolerability of PEP with doravirine.

    28 days

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

    3 months

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

    28 days

Study Arms (1)

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

Interventions

DoravirineDRUG

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

Also known as: Delstrigo®, Pifeltro®
Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de maladies infectieuses et tropicales du CHU de Montpellier

Montpellier, 34295, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

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

Paris, 75013, France

Location

Related Publications (13)

  • 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.

    BACKGROUND

  • 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.

    PMID: 30753724BACKGROUND

  • 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.

    PMID: 32180823BACKGROUND

  • 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.

    PMID: 27894270BACKGROUND

  • 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.

    PMID: 29091217BACKGROUND

  • 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.

    PMID: 31804669BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 35485331BACKGROUND

  • 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.

    PMID: 34570651BACKGROUND

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

doravirine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

June 8, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

October 8, 2024

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Will be decided later by the scientific committee.

Locations

FR(3)