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| ID | Type | Description | Link |
|---|---|---|---|
| N° IDRCB: 2022-A02325-38 | Other Identifier | ANSM, France |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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 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):
Visit 2 (From 42 days to 90 days after PEP treatment initiation)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | The study treatments will used during 28 days according to the routine care of each investigator center. |
|
| 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. | Proportion of subjects who complete the total period of treatment (intake during 28 days). The treatment completeness will be defined as follows:
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the tolerability of PEP with doravirine. | Number and type of side effects. | 28 days |
| To evaluate the prevalence of HIV seroconversion associated with this combination. | Number of subjects with seroconversion. |
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Inclusion Criteria:
Age more than 18 years old
Exposure to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP)
PEP with doravirine:
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: •
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:
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Adult subjects exposed to HIV, leading to the prescription of 28-day post exposure prophylaxis (PEP) with doravirine.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de maladies infectieuses et tropicales du CHU de Montpellier | Montpellier | 34295 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 30753724 | 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. | |
| Label | URL |
|---|---|
| Eviplera: Product information from the European Medecines Agency | View source |
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Will be decided later by the scientific committee.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
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| ID | Term |
|---|---|
| C000592662 | doravirine |
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| 3 months |
| 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). | 28 days |
| Hopital Saint Antoine |
| Paris |
| 75012 |
| France |
| Service de maladies infectieuses et tropicales de de l'hôpital La Pitié-Salpêtrière | Paris | 75013 | France |
| Background |
| 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. |
| 27894270 | Background | 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. |
| 29091217 | Background | 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. |
| 31804669 | Background | 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. |
| Background | 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 |
| 35485331 | 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. |
| 34570651 | Background | 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. |
| Genvoya: Product information from the European Medecines Agency | View source |
| Pifeltro: Product information from the European Medecines Agency | View source |
| Delstrigo: Product information from the European Medecines Agency | View source |
| HIV drugs interactions, University of Liverpool | View source |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |