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New HIV drug could offer safer alternative for First-Time patients

NCT ID NCT06203132

Disease control Sponsor: ANRS, Emerging Infectious Diseases Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study compares two HIV medications, doravirine and dolutegravir, in people who have never taken HIV treatment before. About 610 adults with HIV-1 will receive one of these drugs along with standard medicines. The goal is to see if doravirine works just as well as dolutegravir at controlling the virus after 48 weeks, while possibly causing fewer side effects like weight gain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 610 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV-1-infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Bichat Claude Bernard - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Paris, 75018, France

  • AP-HP Hôpital Lariboisière - Service de Maladies Infectieuses et Tropicales

    RECRUITING

    Paris, 75010, France

  • AP-HP Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Paris, 75013, France

  • AP-HP Hôpital Saint Antoine - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Paris, 75012, France

  • AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Paris, 75010, France

  • CHU Bordeaux Pellegrin - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Bordeaux, 33075, France

  • CHU Bordeaux St André - Service de Médecine Interne

    RECRUITING

    Bordeaux, 33075, France

  • CHU Montpellier - Hôpital La Colombière - Service des Maladies Infectieuses et Tropicales

    RECRUITING

    Montpellier, 34295, France

  • CHU Nantes Hôtel Dieu - Service des Maladies infectieuses et tropicales

    RECRUITING

    Nantes, 44093, France

  • CHU de Treichville, Service des Maladies Infectieuses et Tropicales (SMIT)

    RECRUITING

    Abidjan, Côte d’Ivoire

  • Centre Médical de Suivi des Donneurs de Sang (CMSDS) - Centre National de Transfusion Sanguine (CNTS)

    NOT_YET_RECRUITING

    Abidjan, Côte d’Ivoire

  • Centre de prise en charge de Recherche et de Formation (CEPREF)

    RECRUITING

    Abidjan, Côte d’Ivoire

  • Centro de Saúde 1o de Maio

    RECRUITING

    Maputo, Mozambique

  • Chiangrai Prachanukroh

    RECRUITING

    Chiang Rai, 57000, Thailand

  • Hospital Geral de Nova Iguaçu

    RECRUITING

    Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

  • Hôpital Central de Yaoundé

    RECRUITING

    Yaoundé, Cameroon

  • Laboratory on Clinical research on AIDS-INI FIOCRUZ

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 21040-900, Brazil

  • Lampang Hospital Internal Medicine department

    RECRUITING

    Lampang, 52000, Thailand

  • Phayao Hospital Internal Medicine department

    RECRUITING

    Phayao, 56000, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.