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

Phase 4

Completed

• Conditions: Hiv
• Interventions: Drug: Delstrigo

• Registration Number: NCT04233372
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Study Start: 2020-08-27
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Results First Submitted: 2023-11-29
• Status Verified: 2025-07
• Results First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Results First Posted: 2025-09-10
• Last Update Posted: 2025-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delstrigo	Delstrigo	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen	28 days	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

Secondary Outcome Measures

Name	Time	Method
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	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'
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)	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.
Proportion of Subjects That Maintain Follow-up	Month 4	Absolute frequency and percentage of individuals who performed month 4 (retention rate).
Rate of HIV Seroconversion	Day 0 to Day 84	Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.

Trial Locations

Locations (2)

Department and HIV & HCV Clinical Research Unit University Hospital Nantes; 🇫🇷 Nantes, France

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain