"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk"
NCT ID: NCT05761509
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
226 participants
OBSERVATIONAL
2023-06-08
2024-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Doravirine
The study treatments will used during 28 days according to the routine care of each investigator center.
Interventions
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Doravirine
The study treatments will used during 28 days according to the routine care of each investigator center.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Principal Investigators
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Karine Lacombe, Pr
Role: PRINCIPAL_INVESTIGATOR
Infectious diseases unit / Saint Antoine hospital, Paris (France)
Roland Tubiana, MD
Role: PRINCIPAL_INVESTIGATOR
Infectious diseases unit / La Pitié-Salpêtrière hospital, Paris (France)
Alain Makinson, Pr
Role: PRINCIPAL_INVESTIGATOR
Infectious diseases unit / Montpellier hospital, Montpellier (France)
Locations
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Service de maladies infectieuses et tropicales du CHU de Montpellier
Montpellier, , France
Hopital Saint Antoine
Paris, , France
Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière
Paris, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Eviplera: Product information from the European Medecines Agency
Genvoya: Product information from the European Medecines Agency
Pifeltro: Product information from the European Medecines Agency
Delstrigo: Product information from the European Medecines Agency
HIV drugs interactions, University of Liverpool
Other Identifiers
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N° IDRCB: 2022-A02325-38
Identifier Type: OTHER
Identifier Source: secondary_id
IMEA 067
Identifier Type: -
Identifier Source: org_study_id
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