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

G

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

Status and phase

Completed
Phase 3

Conditions

HIV Risk

Treatments

Drug: Genvoya

Study type

Interventional

Funder types

NETWORK
Industry

Identifiers

NCT02998320
GEFR1044015

Details and patient eligibility

About

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

Full description

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).

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

101 participants in 1 patient group

Genvoya
Experimental group
Description:
Genvoya (E/C/F/TAF) Tablet (oral use) : 150/150/200/10 mg, one tablet each day for 28 days
Treatment:
Drug: Genvoya

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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