Clinical trial • Phase III • Infectious Disease
DORAVIRINE for HIV infection
Phase III trial of DORAVIRINE for HIV infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV infection
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 17-09-2024
- First CTIS Authorization Date
- 07-01-2025
Trial design
Dolutegravir + lamivudine (DTG/3TC) (comparator arm: dolutegravir/lamivudine). Dose and schedule not specified in the provided record.-controlled Phase III trial across 37 sites in France.
- Comparator
- Dolutegravir + lamivudine (DTG/3TC) (comparator arm: dolutegravir/lamivudine). Dose and schedule not specified in the provided record.
- Target Sample Size
- 408
- Trial Duration For Participant
- 672
Eligibility
Recruits 408 No vulnerable populations selected. Only adults (≥18 years) are eligible. Written informed consent is required from participants. No assent or parental consent arrangements are described for minors (minors are excluded). Subject information and informed consent forms for adults are provided in the application documents..
- Pregnancy Exclusion
- • Pregnant or breastfeeding women, and women with age to be pregnant but refusing contraception;
- Vulnerable Population
- No vulnerable populations selected. Only adults (≥18 years) are eligible. Written informed consent is required from participants. No assent or parental consent arrangements are described for minors (minors are excluded). Subject information and informed consent forms for adults are provided in the application documents.
Inclusion criteria
- {"criterion_text":"- •\tAdults ≥18 years;\n- •\tLiving with HIV-1;\n- •\tWith pVL <50 copies/mL for at least 24 months;\n- •\tUnder stable (7 days/7, 5 days/7 or 4 days/7) three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 6 months;\n- •\tAffiliated to the French Social Insurance;\n- •\tWho have given their written consent to participate in the study.\n- •\tPatients with a DNA genotype in which the integrase gene could not be amplified, -\tAnd who have never been exposed to integrase inhibitors, -\tOr who have previously been exposed to integrase inhibitors, but without a history of virological failure;"}
Exclusion criteria
- {"criterion_text":"- •\tHIV-2 co-infection;\n- •\tCo-infection with hepatitis B virus (positive HBsAg and/or positive anti-HBc antibody with negative anti-HBs antibody);\n- •\tDocumented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine, using the last version of the ANRS-MIE algorithm;\n- •\tAt least one resistance genotype is mandatory to include the patient: o\tIf there was no virological failure under NRTI, NNRTI and INSTI in the past: -\tPretherapeutic HIV-RNA genotype, -\tOR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion, o\tIn case of virological failure under NRTI, NNRTI and INSTI in the past: -\tHIV-RNA genotype at time of virological failure, -\tOR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments, o\tPast virological failure is defined as: 2 consecutive pVL ≥50 copies/mL or one pVL ≥200 copies/mL, o\tResistance genotypes will be interpretated with the last available ANRS algorithm.;\n- •\tGlomerular filtration rate <50 mL/min (CKD-EPI formula);\n- •\tComedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);\n- •\tPregnant or breastfeeding women, and women with age to be pregnant but refusing contraception;\n- •\tAny clinal condition limiting the participation in a clinical trial."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants with virological failure at W48 (2 consecutive pVL >50 copies/mL with a delay of 2-4 weeks).","definition_or_measurement_approach":"Virological failure defined as 2 consecutive plasma viral loads (pVL) >50 copies/mL measured 2-4 weeks apart (or as per main objective: 2 consecutive pVL ≥50 copies/mL or one pVL ≥50 copies/mL followed by discontinuation). Assessed at Week 48."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants with virological failure at W96;","definition_or_measurement_approach":"Proportion with virological failure at Week 96 using the same virological failure definition as primary endpoint."}
- {"endpoint_text":"- Proportion of participants with discontinuation of treatment or follow-up over 96 weeks;","definition_or_measurement_approach":"Proportion of participants who discontinue study treatment or follow-up during the 96-week follow-up period."}
- {"endpoint_text":"- Proportion of participants with new resistance associated mutations in case of virological failure;","definition_or_measurement_approach":"Assessment of emergence of resistance-associated mutations at the time of virological failure (genotypic resistance testing)."}
- {"endpoint_text":"- Plasma drug concentrations at W24, W48, W72 and W96, and in case of virological failure;","definition_or_measurement_approach":"Measurement of residual plasma antiretroviral concentrations at Weeks 24, 48, 72 and 96 and at virological failure."}
- {"endpoint_text":"- Proportion of participants with severe biological or clinical side effect over 96 weeks;","definition_or_measurement_approach":"Incidence of clinical or biological adverse events of grade 3 or higher over 96 weeks."}
- {"endpoint_text":"- CD4 and CD8 T-cell counts, CD4/CD8 ratio at D0, W48 and W96;","definition_or_measurement_approach":"Laboratory measurement of CD4 and CD8 T-cell counts and CD4/CD8 ratio at baseline (D0), Week 48 and Week 96."}
- {"endpoint_text":"- Body weight and BMI et IMC at D0, W48 and W96;","definition_or_measurement_approach":"Measurement of body weight and body mass index at baseline, Week 48 and Week 96."}
- {"endpoint_text":"- Metabolic biomarkers (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides and glycemia) at D0, W48 and W96;","definition_or_measurement_approach":"Laboratory assessment of metabolic biomarkers at baseline, Week 48 and Week 96."}
- {"endpoint_text":"- Levels of total HIV-DNA in PBMC at D0, W48 and W96;","definition_or_measurement_approach":"Quantification of total HIV-DNA in peripheral blood mononuclear cells at baseline, Week 48 and Week 96."}
- {"endpoint_text":"- Proportion of participants with residual viremia at D0, W48 and W96;","definition_or_measurement_approach":"Proportion with residual viremia (pVL <20 copies/mL with detectable RT-PCR signal) at baseline, Week 48 and Week 96."}
- {"endpoint_text":"- Levels of satisfaction associated with study treatments at D0, W48 and W96 (HIVTSQ questionnaire);","definition_or_measurement_approach":"Participant-reported treatment satisfaction measured by the HIVTSQ questionnaire at baseline, Week 48 and Week 96."}
- {"endpoint_text":"- Drug concentrations in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study);","definition_or_measurement_approach":"Measurement of antiretroviral concentrations in genital secretions or semen at Weeks 24 and 48 for participants in the genital compartment sub-study."}
- {"endpoint_text":"- Levels of HIV-RNA in female genital secretion or semen at W24 and W48 (among participants of the “genital compartment” sub-study).","definition_or_measurement_approach":"Measurement of HIV-RNA levels in genital secretions or semen at Weeks 24 and 48 for participants in the genital compartment sub-study."}
Recruitment
- Planned Sample Size
- 408
- Recruitment Window Months
- 42
- Consent Approach
- Written informed consent required: participants 'Who have given their written consent to participate in the study.' Consent documents for adults (L1_SIS and ICF_adults and variants) are included in the application. Only adults (≥18 years) are eligible; no assent/parental consent procedures described.
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 408
France
- Earliest CTIS Part Ii Submission Date
- 12-12-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 516
- Number Of Sites
- 37
- Number Of Participants
- 408
Sites
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Post Emergencies Medicine and infectious diseases
- Principal Investigator Name
- Olivier BOLLENGIER STRAGIER
- Principal Investigator Email
- olivier.bollengier-stragier@ght85.fr5.fr
- Contact Person Name
- Olivier BOLLENGIER STRAGIER
- Contact Person Email
- olivier.bollengier-stragier@ght85.fr5.fr
- Site Name
- Centre Hospitalier Universitaire Hôtel-Dieu
- Department Name
- Diagnostic and therapeutic centre
- Principal Investigator Name
- Jean-Paul VIARD
- Principal Investigator Email
- Jean-paul.viard@aphp.fr
- Contact Person Name
- Jean-Paul VIARD
- Contact Person Email
- Jean-paul.viard@aphp.fr
- Site Name
- Hôpital Avicenne
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Hugues CORDEL MACAUX
- Principal Investigator Email
- hugues.cordel@aphp.fr
- Contact Person Name
- Hugues CORDEL MACAUX
- Contact Person Email
- hugues.cordel@aphp.fr
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Romain PALICH
- Principal Investigator Email
- romain.palich@aphp.fr
- Contact Person Name
- Romain PALICH
- Contact Person Email
- romain.palich@aphp.fr
- Site Name
- Hopital Bichat - Claude Bernard
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Jade GHOSN
- Principal Investigator Email
- jade.ghosn@aphp.fr
- Contact Person Name
- Jade GHOSN
- Contact Person Email
- jade.ghosn@aphp.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Claire GENET
- Principal Investigator Email
- claire.genet@chu-limoges.fr
- Contact Person Name
- Claire GENET
- Contact Person Email
- claire.genet@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Pascale FIALAIRE
- Principal Investigator Email
- pafialaire@chu-angers.fr
- Contact Person Name
- Pascale FIALAIRE
- Contact Person Email
- pafialaire@chu-angers.fr
- Site Name
- Centre Hospitalier General De St Denis
- Department Name
- Infectious diseases
- Principal Investigator Name
- Marie-Aude KHUONG-JOSSE
- Principal Investigator Email
- marieaude.khuong@ch-stdenis.fr
- Contact Person Name
- Marie-Aude KHUONG-JOSSE
- Contact Person Email
- marieaude.khuong@ch-stdenis.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Nolwenn HALL
- Principal Investigator Email
- nolwenn.hall@ch-cornouaille.fr
- Contact Person Name
- Nolwenn HALL
- Contact Person Email
- nolwenn.hall@ch-cornouaille.fr
- Site Name
- Hôpital Raymond-Poincaré
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Pierre de TRUCHIS
- Principal Investigator Email
- p.de-truchis@aphp.fr
- Contact Person Name
- Pierre de TRUCHIS
- Contact Person Email
- p.de-truchis@aphp.fr
- Site Name
- Hopital Ambroise Pare
- Department Name
- Infectious diseases
- Principal Investigator Name
- Pierre de TRUCHIS
- Principal Investigator Email
- p.de-truchis@aphp.fr
- Contact Person Name
- Pierre de TRUCHIS
- Contact Person Email
- p.de-truchis@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Pierre DELOBEL
- Principal Investigator Email
- delobel.p@chu-toulouse.fr
- Contact Person Name
- Pierre DELOBEL
- Contact Person Email
- delobel.p@chu-toulouse.fr
- Site Name
- Hopital Saint Antoine
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Karine LACOMBE
- Principal Investigator Email
- karine.lacombe2@aphp.fr
- Contact Person Name
- Karine LACOMBE
- Contact Person Email
- karine.lacombe2@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Alain MAKINSON
- Principal Investigator Email
- a-makinson@chu-montpellier.fr
- Contact Person Name
- Alain MAKINSON
- Contact Person Email
- a-makinson@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- David CHIRIO
- Principal Investigator Email
- chirio.d@chu-nice.fr
- Contact Person Name
- David CHIRIO
- Contact Person Email
- chirio.d@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Amandine GAGNEUX-BRUNON
- Principal Investigator Email
- amandine.gagneux-brunon@chu-st-etienne.fr
- Contact Person Name
- Amandine GAGNEUX-BRUNON
- Contact Person Email
- amandine.gagneux-brunon@chu-st-etienne.fr
- Site Name
- Hopital Antoine-Beclere
- Department Name
- Internal Medicine
- Principal Investigator Name
- Sophie ABGRALL
- Principal Investigator Email
- sophie.abgrall@aphp.fr
- Contact Person Name
- Sophie ABGRALL
- Contact Person Email
- sophie.abgrall@aphp.fr
- Site Name
- Hôpital Lariboisière - APHP
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Agathe Rami
- Principal Investigator Email
- agathe.rami@aphp.fr
- Contact Person Name
- Agathe Rami
- Contact Person Email
- agathe.rami@aphp.fr
- Site Name
- Hopital Tenon
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Gilles PIALOUX
- Principal Investigator Email
- gilles.pialoux@aphp.fr
- Contact Person Name
- Gilles PIALOUX
- Contact Person Email
- gilles.pialoux@aphp.fr
- Site Name
- Nouvel Hopital Civil Strasbourg
- Department Name
- Internal Medicine
- Principal Investigator Name
- Axel URSENBACH
- Principal Investigator Email
- axel.ursenbach@chu-strasbourg.fr
- Contact Person Name
- Axel URSENBACH
- Contact Person Email
- axel.ursenbach@chu-strasbourg.fr
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Claudine DUVIVIER
- Principal Investigator Email
- claudine.duvivier@aphp.fr
- Contact Person Name
- Claudine DUVIVIER
- Contact Person Email
- claudine.duvivier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Fabrice BONNET
- Principal Investigator Email
- Fabrice.bonnet@chu-bordeaux.fr
- Contact Person Name
- Fabrice BONNET
- Contact Person Email
- Fabrice.bonnet@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Internal Medicine, Infectious and Tropical Diseases and Clinical immunology
- Principal Investigator Name
- Firouze BANI-SADR
- Principal Investigator Email
- fbanisadr@chu-reims.fr
- Contact Person Name
- Firouze BANI-SADR
- Contact Person Email
- fbanisadr@chu-reims.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Clotilde ALLAVENA
- Principal Investigator Email
- clotilde.allavena@chu-nantes.fr
- Contact Person Name
- Clotilde ALLAVENA
- Contact Person Email
- clotilde.allavena@chu-nantes.fr
- Site Name
- Centre Hospitalier De Tourcoing
- Department Name
- University of Infectious and Traveller Diseases
- Principal Investigator Name
- Olivier ROBINEAU
- Principal Investigator Email
- orobineau@ch-tourcoing.fr
- Contact Person Name
- Olivier ROBINEAU
- Contact Person Email
- orobineau@ch-tourcoing.fr
- Site Name
- Centre Hospitalier Universitaire de la Guadeloupe
- Department Name
- Ambulatory Medicine Platform
- Principal Investigator Name
- Antoine CHERET
- Principal Investigator Email
- antoine.cheret@aphp.fr
- Contact Person Name
- Antoine CHERET
- Contact Person Email
- antoine.cheret@aphp.fr
- Site Name
- CHU De Martinique
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- André CABIE
- Principal Investigator Email
- andre.cabie@chu-martinique.fr
- Contact Person Name
- André CABIE
- Contact Person Email
- andre.cabie@chu-martinique.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Nathalie DE CASTRO
- Principal Investigator Email
- nathalie.de-castro@aphp.fr
- Contact Person Name
- Nathalie DE CASTRO
- Contact Person Email
- nathalie.de-castro@aphp.fr
- Site Name
- Centre Hospitalier Victor Dupouy
- Department Name
- Immuno-Hématologie, Unité VIH-IST
- Principal Investigator Name
- Fabienne CABY
- Principal Investigator Email
- fabienne.caby@ch-argenteuil.fr
- Contact Person Name
- Fabienne CABY
- Contact Person Email
- fabienne.caby@ch-argenteuil.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Lionel PIROTH
- Principal Investigator Email
- Lionel.piroth@chu-dijon.fr
- Contact Person Name
- Lionel PIROTH
- Contact Person Email
- Lionel.piroth@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Charles CAZANAVE
- Principal Investigator Email
- charles.cazanave@chu-bordeaux.fr
- Contact Person Name
- Charles CAZANAVE
- Contact Person Email
- charles.cazanave@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Clinical immuno-hematology
- Principal Investigator Name
- Olivia ZAEGEL-FAUCHER
- Principal Investigator Email
- olivia.zaegel@ap-hm.fr
- Contact Person Name
- Olivia ZAEGEL-FAUCHER
- Contact Person Email
- olivia.zaegel@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire de Clermont-Ferrand - Hôpital Gabriel Montpied
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Florence ANGLADE
- Principal Investigator Email
- fanglade@chu-clermontferrand.fr
- Contact Person Name
- Florence ANGLADE
- Contact Person Email
- fanglade@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Lea PICARD
- Principal Investigator Email
- lea.picard@chu-rennes.fr
- Contact Person Name
- Lea PICARD
- Contact Person Email
- lea.picard@chu-rennes.fr
- Site Name
- Centre Hospitalier Intercommunal de Villeneuve Saint Georges
- Department Name
- Infectious diseases
- Principal Investigator Name
- Pauline CARAUX-PAZ
- Principal Investigator Email
- pauline.caraux-paz@chiv.fr
- Contact Person Name
- Pauline CARAUX-PAZ
- Contact Person Email
- pauline.caraux-paz@chiv.fr
- Site Name
- Centre Hospitalier Universitaire D Orleans
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Laurent HOCQUELOUX
- Principal Investigator Email
- Laurent.hocqueloux@chu-orleans.fr
- Contact Person Name
- Laurent HOCQUELOUX
- Contact Person Email
- Laurent.hocqueloux@chu-orleans.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Amélie MENARD
- Principal Investigator Email
- amelie.menard@ap-hm.fr
- Contact Person Name
- Amélie MENARD
- Contact Person Email
- amelie.menard@ap-hm.fr
Sponsor
Primary sponsor
- Full Name
- Centre De Recherches Et D'Etudes Sur La Pathologie Tropicale Et Le Sida
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Third parties
- {"country":"","full_name":"Agence Nationale de Recherche sur les hépatites, le VIH/SIDA et les Maladies Infectieuses Emergentes","duties_or_roles":"Monetary support / funding","organisation_type":""}
Co-sponsors
- ANRS Maladies Infectieuses Emergentes
Investigational products
- Investigational Product Name
- DORAVIRINE
- Active Substance
- DORAVIRINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 100 mg
- Investigational Product Name
- LAMIVUDINE
- Active Substance
- LAMIVUDINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 300 mg
- Investigational Product Name
- LAMIVUDINE AND DOLUTEGRAVIR
- Active Substance
- LAMIVUDINE, DOLUTEGRAVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Combination Treatment
- Yes
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