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: September 9, 2025
Sponsor: Hospital Clinic of Barcelona
Overall Status: Completed

Phase

4

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv

Treatment

Delstrigo

Clinical Study ID

NCT04233372
DORAVIPEP
2019-004140-30
  • 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 threeantiretroviral drugs.

  • Who after being fully informed, give their written consent to participate in thestudy and 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 studyperiod.

  • Patients in whom it is known or suspected that the source case has a resistance toone of the drugs from the study treatment regimens.

  • Treatment with drugs that are contraindicated in the study or products that are inthe investigational phase.

  • Allergic reactions or intolerance to the compounds of the study treatment regiments

Study Design

Total Participants: 399
Treatment Group(s): 1
Primary Treatment: Delstrigo
Phase: 4
Study Start date:
August 27, 2020
Estimated Completion Date:
July 28, 2022

Connect with a study center

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

    Nantes,
    France

    Site Not Available

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

    Nantes 2990969,
    France

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

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