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DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road) (DOR)

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ClinicalTrials.gov Identifier: NCT06034938
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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Brief Summary:
The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.

Condition or disease Intervention/treatment Phase
Hiv Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO] Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, non-comparative, single arm pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm DOR/3TC/TDF
Doravirine 100 mg Lamivudine 300 mg Tenofovir disoproxil fumarate 245 mg Delstrigo (R): 1 pill/day for 48 weeks
 Drug: Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]
Switch previous therapy with DOR/TDF/3TC
Other Name: Delstrigo


Outcome Measures
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Primary Outcome Measures :
  1. Plasma HIV-RNA at 24-week [ Time Frame: 24 weeks from the switch to DOR/3TC/TDF ]
    Number of copies/mL


Secondary Outcome Measures :
  1. Plasma HIV-RNA at 48-week [ Time Frame: 48 weeks from the switch to DOR/3TC/TDF ]
    Number of copies/mL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult living with HIV
  • Receiving stable antiretroviral treatment for at least 3 months
  • HIV RNA VL<50cp/mL for at least 6 months
  • Presence of the M184V/I mutation in at least one previous genotype performed on plasma HIV RNA but absent from the genotype on current standard pro-viral DNA (Sanger technique)
  • Signed informed consent

Exclusion Criteria:

  • History of genotypic mutation associated with resistance to DOR or TDF according to the ANRS version 32 algorithm, i.e. :
  • For DOR : V106A/M; Y188L; G190E/S; M230L; L100I + K103N; K103N + Y181C; K103N + P225H; F227C; At least 3 amongst: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y
  • For TDF : At least 3 mutations among: M41L, E44D, D67N, T69D/N/S, L74V/I, L210W, T215A/C/D/E/G/H/I/L/N/S/V/Y/F; K65R/E/N ; Insertion at codon 69; K70E
  • Contraindications to the use of DOR/TDF/3TC
  • Hypersensitivity to doravirine, tenofovir, lamivudine or any of the excipients (lactose in particular)
  • Current or recent treatment with a strong CYP3A4 inducer
  • Breast-feeding
  • Patients already on DOR
  • Pregnant or breast-feeding women
  • Patients under guardianship or trusteeship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034938


Contacts
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Contact: Jean-Jacques Parienti, MD, PhD +33231064320 parienti-jj@chu-caen.fr
Contact: Francois Fournel, MSc fournel-f@chu-caen.fr

Locations
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France
CHU de Caen
Caen, France
CHU Orléans
Orléans, France
Contact: Laurent Hocqueloux, MD         
Contact    +33238514444      
CHU Rouen
Rouen, France
Contact: Manuel Etienne, MD, PhD    +33 232888990      
CH Tourcoing
Tourcoing, France
Contact: Olivier Robineau    +33 320694949      
Sponsors and Collaborators
University Hospital, Caen
Merck Sharp & Dohme LLC
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT06034938    
Other Study ID Numbers: MISP-RC_Parienti007
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact principal investigator
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 2-year after publishing the princeps study
Access Criteria: Relevant scientific question with protocol

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University Hospital, Caen:
doravirine
M184 mutation
Maintenance therapy
PLWH
Additional relevant MeSH terms:
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Tenofovir
Lamivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents