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

• Conditions: Hiv

• Registration Number: NCT04233372
• Lead Sponsor: David Garcia Cinca

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
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-07
• Primary Completion: 2021-02-15
• Study Completion: 2021-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with treatment completion at day 28	28 days	Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis 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.

Secondary Outcome Measures

Name	Time	Method
Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy	28 days
Assess the baseline characteristics associated to non-completion.	28 days	% of non-completion patients by age, sex, sexual orientation, origin, comorbilities, previous post exposition prophylaxis treatment, previous sexual transmitted infections and use of abuse drugs.
Description of adherence to combination antiretroviral therapy, including the time until loss of adherence	28 days
Proportion of subjects that maintain follow-up	12 weeks
Rate of HIV Seroconversion	12 weeks

Trial Locations

Locations (2)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

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