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

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

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Drug: Delstrigo

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Department and HIV & HCV Clinical Research Unit University Hospital Nantes
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delstrigo	Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen	Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion is considered in cases: If the subject dies.; Does not go to visits (loss of follow-up); Change or suspend the treatment under study for any reason.; Consent withdrawal	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF		28 days
Assess the Baseline Characteristics Associated to Treatment Non-completion.	Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment'	28 days
Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF		28 days
Adherence to cART During 28-day PEP Regimen	Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count.	Day 0 to Day 28 (Week 4)
Proportion of Subjects That Maintain Follow-up	Absolute frequency and percentage of individuals who performed month 4 (retention rate).	Month 4
Rate of HIV Seroconversion	Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.	Day 0 to Day 84

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Dr. Josep Mallolas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: DORAVIPEP; 2019-004140-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No