Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

Last updated: December 3, 2020
Sponsor: David Garcia Cinca
Overall Status: Active - Recruiting

Phase

4

Condition

Hiv

Treatment

N/A

Clinical Study ID

NCT04233372
DORAVIPEP
  • Ages > 18
  • All Genders

Study Summary

Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects attending emergency room due to potential HIV exposition of either sex:
  • Aged 18 years or more.
  • Who have been exposed to non-occupational HIV and who meet the prerequisites for thecurrent recommendations to begin prophylaxis post-exposition with three antiretroviraldrugs.
  • Who after being fully informed, give their written consent to participate in the studyand undergo the tests and examinations required.
  • Individuals able to do follow up correctly.

Exclusion

Exclusion Criteria:

  • Pregnant women or nursing mothers or women trying to conceive during the study period.
  • Patients in whom it is known or suspected that the source case has a resistance to oneof the drugs from the study treatment regimens.
  • Treatment with drugs that are contraindicated in the study or products that are in theinvestigational phase.
  • Allergic reactions or intolerance to the compounds of the study treatment regiments

Study Design

Total Participants: 400
Study Start date:
August 27, 2020
Estimated Completion Date:
March 15, 2021

Connect with a study center

  • Department and HIV & HCV Clinical Research Unit University Hospital Nantes

    Nantes,
    France

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

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