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

NCT ID: NCT04233372

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 399 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-27
• Study Completion Date: 2022-07-28

Brief Summary

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

Conditions

Hiv

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Delstrigo

Group Type: EXPERIMENTAL

Delstrigo

Intervention Type: DRUG

Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.

1 covered tablet for day .( will be administered 28 days maximum)

Interventions

Delstrigo

Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.

1 covered tablet for day .( will be administered 28 days maximum)

Intervention Type: DRUG

Eligibility Criteria

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 the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs.
• Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
• Individuals able to do follow up correctly.

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 one of the drugs from the study treatment regimens.
• Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
• Allergic reactions or intolerance to the compounds of the study treatment regiments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department and HIV & HCV Clinical Research Unit University Hospital Nantes

Nantes, , France

Hospital Clínic de Barcelona

Barcelona, , Spain

Countries

France; Spain

References

Inciarte A, Ugarte A, Martinez-Rebollar M, Torres B, Fernandez E, Berrocal L, Laguno M, De la Mora L, De Lazzari E, Callau P, Chivite I, Gonzalez-Cordon A, Solbes E, Rico V, Barrero L, Blanco JL, Martinez E, Ambrosioni J, Mallolas J; DORAVIPEP Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP). Open Forum Infect Dis. 2023 Jul 19;10(8):ofad374. doi: 10.1093/ofid/ofad374. eCollection 2023 Aug.

Reference Type: DERIVED

PMID: 37539061 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019-004140-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DORAVIPEP

Identifier Type: -

Identifier Source: org_study_id