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

NCT04233372 | Completed Phase 4 Results

• 2 other identifiers: DORAVIPEP2019-004140-30
• Study Type: interventional
• Target: 399
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• 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: 1. If the subject dies. 2. Does not go to visits (loss of follow-up) 3. Change or suspend the treatment under study for any reason. 4. Consent withdrawal

  28 days

Secondary Outcomes (6)

• 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.

  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

  Day 0 to Day 28 (Week 4)

• Proportion of Subjects That Maintain Follow-up

  Month 4

Study Arms (1)

Delstrigo

EXPERIMENTAL

Drug: Delstrigo

Interventions

Delstrigo 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)

Delstrigo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Department and HIV & HCV Clinical Research Unit University Hospital Nantes

Nantes, France

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 37539061 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

This was a single-arm, open-label study without a comparator group, which limits the ability to attribute outcomes solely to the intervention. Additionally, the number of participants affected per adverse event category was not specified, restricting detailed safety analysis. Follow-up rates decreased over time, potentially impacting data completeness.

Results Point of Contact

• Title: Dr. Alexy Inciarte
• Organization: Hospital Clínic of Barcelona

ajinciar@clinic.cat

+34932275400

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 18, 2020
• Study Start: August 27, 2020
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-07

Locations

FR (1); ES (1)