Switching to doravirine/tenofovir/lamivudine for people with controlled HIV and a past M184V/I mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm pilot in which eligible adults with suppressed HIV and a prior M184V/I mutation will switch their antiretroviral regimen to a fixed-dose doravirine/lamivudine/tenofovir tablet (Delstrigo) and be followed for 48 weeks. The primary outcome is the proportion of participants with HIV RNA <50 copies/mL at 24 weeks after the switch, with continued virologic monitoring to week 48. Secondary endpoints include changes in metabolic and weight parameters and tracking of HIV-DNA mutations over time using proviral genotyping. Participants must have had viral suppression for at least 6 months and a documented past M184V/I on plasma genotype while lacking that mutation on current proviral DNA Sanger testing.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Caen
  Caen, France Recruiting
• CHU Orléans
  Orléans, France Recruiting
• CHU Rouen
  Rouen, France Recruiting
• CH Tourcoing
  Tourcoing, France Recruiting

Study contacts

• Study coordinator: Jean-Jacques Parienti, MD, PhD
• Email: parienti-jj@chu-caen.fr
• Phone: +33231064320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.