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

Hiv Clinical Trial

— DORAVIPEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233372
• Other study ID #: DORAVIPEP
• Status: Recruiting
• Phase: Phase 4
• Start date: August 27, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2020
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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)

Locations

Country	Name	City	State
France	Department and HIV & HCV Clinical Research Unit University Hospital Nantes	Nantes
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
David Garcia Cinca	Dr. Josep Mallolas

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with treatment completion at day 28	Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis 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.	28 days
Secondary	Assess the baseline characteristics associated to non-completion.	% 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.	28 days
Secondary	Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy		28 days
Secondary	Description of adherence to combination antiretroviral therapy, including the time until loss of adherence		28 days
Secondary	Proportion of subjects that maintain follow-up		12 weeks
Secondary	Rate of HIV Seroconversion		12 weeks