Skip to main content
OpenTrials
Completed

NCT Number: NCT04233372

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department and HIV & HCV Clinical Research Unit University Hospital Nantes, Nantes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delstrigo

Drug

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)

Primary outcomes

  1. Proportion of Participants Who Did Not Complete the 28-day PEP Regimen

    Time frame: 28 days

    Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) 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.
    • Consent withdrawal

Secondary outcomes

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

    Time frame: 28 days

  2. Assess the Baseline Characteristics Associated to Treatment Non-completion.

    Time frame: 28 days

    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'

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

    Time frame: 28 days

  4. Adherence to cART During 28-day PEP Regimen

    Time frame: Day 0 to Day 28 (Week 4)

    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.

  5. Proportion of Subjects That Maintain Follow-up

    Time frame: Month 4

    Absolute frequency and percentage of individuals who performed month 4 (retention rate).

  6. Rate of HIV Seroconversion

    Time frame: Day 0 to Day 84

    Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Acronym: DORAVIPEP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2020
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.