Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis
NCT ID: NCT02998320
Last Updated: 2019-02-15
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
PHASE3
101 participants
INTERVENTIONAL
2017-03-10
2018-09-30
Brief Summary
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Detailed Description
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Elvitegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Cobicistat is a selective, mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A subfamily. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue àf 2'-dexicytidine. Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonoamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Genvoya
Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
Genvoya
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
Interventions
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Genvoya
Oral use (one tablet each day); 150/150/200/10 mg; 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* consultation within 48 hours following a risk of HIV transmission (blood or sexual contact)
* indication for HIV post-exposure prophylaxis (according to French guidelines)
* person able to understand the nature of the study
* person who signed his consent form to participate in the study
Exclusion Criteria
* contraindications to the prescription of Genvoy
* other medical contraindications
* person infected by hepatitis B virus
* pregnant or lactating woman
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
NETWORK
Responsible Party
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Principal Investigators
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David Rey
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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Hôpital Jean Minjoz
Besançon, , France
Hôpital Saint-André
Bordeaux, , France
CHU Ambroise Paré
Boulogne-Billancourt, , France
Hôpital Manchester
Charleville-Mézières, , France
CHU Dijon
Dijon, , France
Hôpital Croix Rousse
Lyon, , France
CHR de Metz
Metz, , France
CHU Bichat
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital Saint-Antoine
Paris, , France
GH Pitié Salpetriere
Paris, , France
CHU de Reims
Reims, , France
CHU
Rennes, , France
Hôpitaux Universitaires
Strasbourg, , France
Hôpital Foch
Suresnes, , France
Hôpital de Tourcoing
Tourcoing, , France
Countries
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References
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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.
Other Identifiers
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GEFR1044015
Identifier Type: -
Identifier Source: org_study_id
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