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

Hospital Clinic of Barcelona399 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

399

Conditions

Hiv

Interventions

DelstrigoDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Department and HIV & HCV Clinical Research Unit University Hospital Nantes

Nantes, France

Hospital Clínic de Barcelona

Barcelona, Spain

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF

Time frame: 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'

Time frame: 28 days

Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF

Time frame: 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.

Time frame: 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).

Time frame: 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®.

Data from ClinicalTrials.gov

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