NCT06203132 DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection
| NCT ID | NCT06203132 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Condition | HIV-1-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 610 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 610 participants in total. It began in 2025-01-27 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
Eligibility Criteria
Inclusion Criteria: * 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 ≥1000 copies/mL within 30 days prior to the randomization, * Have HIV treatment indication based on physician assessment according to local treatment guidelines * Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents * For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods * Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial. Non-inclusion Criteria: * Has ongoing (pulmonary or extra-pulmonary) tuberculosis * Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate. * Is infected with HIV-2 or co-infected with HIV-1 and HIV-2 * Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP). * Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed * Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group * Has the following laboratory values at screening visit, within 30 days prior to the randomization: * AST (SGOT) and ALT (SGPT) \>4.0 x upper limit of normal * Estimated glomerular filtration rate at time of screening \<60 mL/min/1.73m², based on the CKD-EPI equation * Has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study. * Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study * Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol. * Has significant hypersensitivity or other contraindication to any of the components of the study drugs. * Is pregnant, breastfeeding, or expecting to conceive at any time during the study. * Has any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to study procedure. * Is a person under guardianship or deprived of freedom by a judicial or administrative decision
Contact & Investigator
Pierre SELLIER, Dr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06203132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV-1-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06203132 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 610 participants.
Is NCT06203132 currently recruiting?
Yes, NCT06203132 is actively recruiting participants. Contact the research team at anthony.lhostellier@u-bordeaux.fr for enrollment information.
Where is the NCT06203132 trial being conducted?
This trial is being conducted at Nova Iguaçu, Brazil, Rio de Janeiro, Brazil, Yaoundé, Cameroon, Abidjan, Côte d’Ivoire and 11 additional locations.
Who is sponsoring the NCT06203132 clinical trial?
NCT06203132 is sponsored by ANRS, Emerging Infectious Diseases. The principal investigator is Pierre SELLIER, Dr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 610 participants.
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