Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified January 2020 by David Garcia Cinca

Sponsor
David Garcia Cinca

Collaborator
Dr. Josep Mallolas

Information provided by (Responsible Party)
David Garcia Cinca, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier
NCT04233372

First received: December 20, 2019
Last updated: January 16, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Hiv

Drug : Delstrigo
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Further study details as provided by David Garcia Cinca, Hospital Clinic of Barcelona:

Primary Outcome Measures

  • 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: If the subject dies. Does not go to visits (loss of follow-up) Change or suspend the treatment under study for any reason.
Secondary Outcome Measures:
  • 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.
  • Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy [ Time Frame: 28 days ]
  • Description of adherence to combination antiretroviral therapy, including the time until loss of adherence [ Time Frame: 28 days ]
  • Proportion of subjects that maintain follow-up [ Time Frame: 12 weeks ]
  • Rate of HIV Seroconversion [ Time Frame: 12 weeks ]

Estimated Enrollment: 400
Study Start Date: February 15, 2020
Estimated Study Completion Date: March 15, 2021
Estimated Primary Completion Date: February 15, 2021 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04233372

Locations

France
Department and HIV & HCV Clinical Research Unit University Hospital Nantes
Nantes, France
Contact: François Raffi, MD
Spain
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Contact: Josep Mallolas, MD    mallolas@clinic.cat
Sub-Investigator: Alexy Iniciarte, MD

Sponsors and Collaborators

David Garcia Cinca
Dr. Josep Mallolas
More Information

More Information


Responsible Party: David Garcia Cinca, Study Coordinator, Hospital Clinic of Barcelona  
ClinicalTrials.gov Identifier: NCT04233372   History of Changes  
Other Study ID Numbers: DORAVIPEP  
Study First Received: December 20, 2019  
Last Updated: January 16, 2020  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.