Completed

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

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What is being tested

Delstrigo

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: August 2020
See protocol details

Summary

Principal SponsorHospital Clinic of Barcelona
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 27, 2020

Actual date on which the first participant was enrolled.

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

Official TitleEvaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
NCT04233372
Principal SponsorHospital Clinic of Barcelona
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

399 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

5 inclusion criteria required to participate
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.
Show More Criteria
4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Department and HIV & HCV Clinical Research Unit University Hospital Nantes

Nantes, FranceOpen Department and HIV & HCV Clinical Research Unit University Hospital Nantes in Google Maps
Suspended

Hospital Clínic de Barcelona

Barcelona, Spain
Completed2 Study Centers