Dolutegravir + tenofovir DF + lamivudine or emtricitabine: Oral administration
Study summary
Phase III trial evaluating doravirine as an alternative to dolutegravir in treatment naïve people living with HIV-1 infection.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Non-inferiority of doravirine in combination with tenofovir and lamivudine as compared to dolutegravir in combination with tenofovir and lamivudine or emtricitabine in terms of virological efficacy at week 48 — Week 48 The non-inferiority will be assessed in terms of virologic efficacy at week 48 under allocated treatment using the FDA snapshot algorithm (window period of 42-54 weeks), and measured by the proportion of subjects achieving a rate of HIV 1 RNA \<50 copies/mL, in HIV-1 infected, treatment-naive subjects with pre-treatment viral load (HIV-1 RNA) ≥ 1,000 copies/mL.
The rate of HIV 1 RNA will be measured by RT-PCR.
Trial sites (19)
Facility
City
Region
Status
Hospital Geral de Nova Iguaçu
Nova Iguaçu
Rio de Janeiro
Recruiting
Laboratory on Clinical research on AIDS-INI FIOCRUZ
Rio de Janeiro
Rio de Janeiro
Recruiting
Hôpital Central de Yaoundé
Yaoundé
Cameroon
Recruiting
Centre de prise en charge de Recherche et de Formation (CEPREF)
Abidjan
Côte d’Ivoire
Recruiting
Centre Médical de Suivi des Donneurs de Sang (CMSDS) - Centre National de Transfusion Sanguine (CNTS)
Abidjan
Côte d’Ivoire
Not Yet Recruiting
CHU de Treichville, Service des Maladies Infectieuses et Tropicales (SMIT)
Abidjan
Côte d’Ivoire
Recruiting
CHU Bordeaux Pellegrin - Service des Maladies Infectieuses et Tropicales
Bordeaux
France
Recruiting
CHU Bordeaux St André - Service de Médecine Interne
Bordeaux
France
Recruiting
CHU Montpellier - Hôpital La Colombière - Service des Maladies Infectieuses et Tropicales
Montpellier
France
Recruiting
CHU Nantes Hôtel Dieu - Service des Maladies infectieuses et tropicales
Nantes
France
Recruiting
AP-HP Hôpital Lariboisière - Service de Maladies Infectieuses et Tropicales
Paris
France
Recruiting
AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales
Paris
France
Recruiting
AP-HP Hôpital Saint Antoine - Service des Maladies Infectieuses et Tropicales
Paris
France
Recruiting
AP-HP Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses et Tropicales
Paris
France
Recruiting
AP-HP Bichat Claude Bernard - Service des Maladies Infectieuses et Tropicales
Paris
France
Recruiting
Centro de Saúde 1o de Maio
Maputo
Mozambique
Recruiting
Chiangrai Prachanukroh
Chiang Rai
Thailand
Recruiting
Lampang Hospital Internal Medicine department
Lampang
Thailand
Recruiting
Phayao Hospital Internal Medicine department
Phayao
Thailand
Recruiting
More ANRS, Emerging Infectious Diseases trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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