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Completed

NCT Number: NCT02998320

Evaluation of Compliance With Treatment by Genvoya in HIV Post-exposure Prophylaxis

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Genvoya for four weeks

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Key information

Conditions

HIV Risk

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Jean Minjoz, Besançon, France

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About this study

This study measures the proportion of enrolled patients taking the uninterrupted HIV post-exposure prophylaxis Elvitegravir/Cobicistat/FTC/Tenofovir alafenamide (E/C/F/TAF) for four Weeks.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • an age above 18 years
  • 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

  • person exposed to HIV risk from person infected by HIV, whose therapeutic history justifies the prescription of another combination of antiretroviral drugs
  • contraindications to the prescription of Genvoy
  • other medical contraindications
  • person infected by hepatitis B virus
  • pregnant or lactating woman

Treatment and study plan

Genvoya

Drug

Oral use (one tablet each day); 150/150/200/10 mg; 28 days

Other names: (E/C/F/TAF) ATC Code: J05AR18

Primary outcomes

  1. Proportion of patients taking the uninterrupted HIV post-exposure prophylaxis for four weeks

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Network

Collaborators

  • Gilead Sciences

Registry information

Official study title

Evaluation of Compliance With Treatment by Elvitegravir/Cobicistat/FTC/Tenofovir Alafenamide (E/C/F/TAF) in HIV Post-exposure Prophylaxis (to Infected Blood or Sexual Contact)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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