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

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

Hiv

Treatments

Drug: Delstrigo

Study type

Interventional

Funder types

Other

Identifiers

2019-004140-30 (EudraCT Number)

DORAVIPEP

Details and patient eligibility

About

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

Enrollment

399 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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