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

December 3, 2020 updated by: David Garcia Cinca
Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Not yet recruiting
        • Department and HIV & HCV Clinical Research Unit University Hospital Nantes
        • Contact:
          • François Raffi, MD
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
        • Sub-Investigator:
          • Alexy Iniciarte, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with treatment completion at day 28
Time Frame: 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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the baseline characteristics associated to non-completion.
Time Frame: 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.
28 days
Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy
Time Frame: 28 days
28 days
Description of adherence to combination antiretroviral therapy, including the time until loss of adherence
Time Frame: 28 days
28 days
Proportion of subjects that maintain follow-up
Time Frame: 12 weeks
12 weeks
Rate of HIV Seroconversion
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Garcia Cinca

Collaborators

Dr. Josep Mallolas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2020

Primary Completion (Anticipated)

February 15, 2021

Study Completion (Anticipated)

March 15, 2021

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DORAVIPEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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