NCT06034938

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_2 hiv

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

September 6, 2023

Last Update Submit

July 21, 2025

Conditions

Hiv

Keywords

doravirineM184 mutationMaintenance therapyPLWH

Outcome Measures

Primary Outcomes (1)

  • Plasma HIV-RNA at 24-week

    Number of copies/mL

    24 weeks from the switch to DOR/3TC/TDF

Secondary Outcomes (1)

  • Plasma HIV-RNA at 48-week

    48 weeks from the switch to DOR/3TC/TDF

Study Arms (1)

Single arm DOR/3TC/TDF

EXPERIMENTAL

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]

Interventions

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]DRUG

Switch previous therapy with DOR/TDF/3TC

Also known as: Delstrigo
Single arm DOR/3TC/TDF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Caen

Caen, France

RECRUITING

CHU Orléans

Orléans, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

CH Tourcoing

Tourcoing, France

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

doravirineLamivudineTenofovir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Jean-Jacques Parienti, MD, PhD

CONTACT

+33231064320parienti-jj@chu-caen.fr

Francois Fournel, MSc

CONTACT

fournel-f@chu-caen.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, non-comparative, single arm pilot trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

February 8, 2024

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Contact principal investigator

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
2-year after publishing the princeps study
Access Criteria
Relevant scientific question with protocol

Locations

FR(4)