Actively Recruiting
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
Led by ANRS, Emerging Infectious Diseases · Updated on 2026-01-07
610
Participants Needed
19
Research Sites
144 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
M
MSD France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
CONDITIONS
Official Title
DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years of age on the day of signing the informed consent.
- Be HIV-1 positive as determined according to national testing strategies.
- Have a plasma HIV-1 RNA of at least 1000 copies/mL within 30 days prior to randomization.
- Have HIV treatment indication based on physician assessment according to local treatment guidelines.
- Be naive to antiretroviral therapy including investigational antiretroviral agents.
- For women or transgender men of childbearing potential, have a negative urinary pregnancy test and agree to use contraceptive methods.
- Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.
You will not qualify if you...
- Have ongoing pulmonary or extra-pulmonary tuberculosis.
- Have any condition, therapy, laboratory abnormality, or circumstance that might interfere with participation or study results.
- Be infected with HIV-2 or co-infected with HIV-1 and HIV-2.
- Have received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).
- Have received oral PrEP or post-exposure prophylaxis (PEP) in the past three months or have no negative HIV-1 serology.
- Have documented or possible resistance to study drugs as defined by local guidelines.
- Have AST (SGOT) and ALT (SGPT) levels greater than 4 times the upper limit of normal.
- Have an estimated glomerular filtration rate below 60 mL/min/1.73m² at screening.
- Have participated in a study with investigational compounds/devices within 30 days prior or plan to during this study.
- Have used systemic immunosuppressive therapy or immune modulators within 30 days prior or expect to need them during the study.
- Require prohibited or contraindicated medications noted in the trial protocol.
- Have significant hypersensitivity or contraindication to any study drug components.
- Are pregnant, breastfeeding, or expect to conceive during the study.
- Have any condition compromising safety or adherence.
- Are under guardianship or deprived of freedom by judicial or administrative decision.
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, Brazil, 26030-380
Actively Recruiting
2
Laboratory on Clinical research on AIDS-INI FIOCRUZ
Rio de Janeiro, Rio de Janeiro, Brazil, 21040-900
Actively Recruiting
3
Hôpital Central de Yaoundé
Yaoundé, Cameroon
Actively Recruiting
4
Centre de prise en charge de Recherche et de Formation (CEPREF)
Abidjan, Côte d’Ivoire
Not Yet Recruiting
5
Centre Médical de Suivi des Donneurs de Sang (CMSDS) - Centre National de Transfusion Sanguine (CNTS)
Abidjan, Côte d’Ivoire
Not Yet Recruiting
6
CHU de Treichville, Service des Maladies Infectieuses et Tropicales (SMIT)
Abidjan, Côte d’Ivoire
Actively Recruiting
7
CHU Bordeaux Pellegrin - Service des Maladies Infectieuses et Tropicales
Bordeaux, France, 33075
Actively Recruiting
8
CHU Bordeaux St André - Service de Médecine Interne
Bordeaux, France, 33075
Actively Recruiting
9
CHU Montpellier - Hôpital La Colombière - Service des Maladies Infectieuses et Tropicales
Montpellier, France, 34295
Actively Recruiting
10
CHU Nantes Hôtel Dieu - Service des Maladies infectieuses et tropicales
Nantes, France, 44093
Actively Recruiting
11
AP-HP Hôpital Lariboisière - Service de Maladies Infectieuses et Tropicales
Paris, France, 75010
Actively Recruiting
12
AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales
Paris, France, 75010
Actively Recruiting
13
AP-HP Hôpital Saint Antoine - Service des Maladies Infectieuses et Tropicales
Paris, France, 75012
Actively Recruiting
14
AP-HP Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris, France, 75013
Actively Recruiting
15
AP-HP Bichat Claude Bernard - Service des Maladies Infectieuses et Tropicales
Paris, France, 75018
Actively Recruiting
16
Centro de Saúde 1o de Maio
Maputo, Mozambique
Actively Recruiting
17
Chiangrai Prachanukroh
Chiang Rai, Thailand, 57000
Not Yet Recruiting
18
Lampang Hospital Internal Medicine department
Lampang, Thailand, 52000
Not Yet Recruiting
19
Phayao Hospital Internal Medicine department
Phayao, Thailand, 56000
Not Yet Recruiting
Research Team
A
Anthony L'HOSTELLIER
CONTACT
O
Olivier MARCY, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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