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Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women (PREDUAL)

15 septembre 2026 mis à jour par: Maria Ines Figueroa, Fundación Huésped

Evaluating the Efficacy and Safety of Dolutegravir/Lamivudine (DTG/3TC) in ART-Naïve Pregnant Women

Protocol Number: FH-94

Study Objetives:

Primary:

  • To evaluate the virological response to Dolutegravir/Lamivudine in naive pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates.

Secondary:

  • To evaluate the incidence of maternal adverse events.
  • To evaluate perinatal outcomes at delivery.
  • To evaluate maximum virological suppression at delivery.
  • To evaluate the incidence of changes in body weight exceeding what is expected for gestation.
  • To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
  • Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC or DTG+TDF/XTC or DTG+TAF/FTC.
  • To evaluate the incidence of HIV infection in children that breastfeed.
  • To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC.

Exploratory:

  • To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
  • To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Primary endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months

Secondary endpoints:

  • Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum.
  • Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
  • Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
  • Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
  • Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
  • Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
  • Proportion of HIV infection among breastfed children.
  • Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms. Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit.

Exploratory endpoints:

  • Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
  • Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery.

Patient Population: HIV-1-infected Pregnant Women aged >16 years (>15 years for Brazil's sites) who are naïve to antiretroviral therapy Study design: Phase IV. Randomized, non-comparative, open-label, multicenter study.

Regimens: Dolutegravir 50 mg /lamivudine 300 mg QD FDC. Dolutegravir 50 mg QD plus tenofovir 300 mg/emtricitabine 200mg or plus tenofovir 300 mg/ lamivudine 300 mg or tenofovir alafenamide 25 mg/emtricitabine 200 mg.

Duration: 14 months approximately months (depending on gestational age at entry).

Sample size: 210 subjects

Type d'étude

Interventionnel

Inscription (Estimé)

210

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Argentine
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentine, C1155AHD
        • Recrutement
        • Hospital General de Agudos Dr. Cosme Argerich
        • Contact:
        • Chercheur principal:
          • Diego Cecchini, MD
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentine, C1188AAF
        • Recrutement
        • Sanatorio Güemes
        • Contact:
        • Contact:
          • Sebastián Nuñez, MD
          • Numéro de téléphone: 8384 / 8365 +54 11 4959-8200
          • E-mail: snunez@fsg.edu.ar
        • Chercheur principal:
          • Verónica Lacal, MD
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentine, C1425AGP
      • El Palomar, Buenos Aires, Argentine, B1684
        • Pas encore de recrutement
        • Hospital Nacional Profesor Alejandro Posadas
        • Contact:
        • Chercheur principal:
          • Mariana Golikow, MD
      • Isidro Casanova, Buenos Aires, Argentine, B1765
        • Pas encore de recrutement
        • Hospital de Agudos Paroissien
        • Contact:
        • Contact:
        • Chercheur principal:
          • Pablo Garnica, MD
  • Brésil
      • São Paulo, Brésil, 04037-030
        • Pas encore de recrutement
        • RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution
        • Contact:
        • Chercheur principal:
          • Ricardo Sobhie Diaz, MD
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brésil, 40110-160
        • Pas encore de recrutement
        • Fundação Bahiana de Infectologia
        • Contact:
        • Contact:
        • Chercheur principal:
          • Carlos Brites, MD
    • Pernambuco
      • Curitiba, Pernambuco, Brésil, 80430-000
        • Pas encore de recrutement
        • Complexo do Hospital de Clínicas da UFPR/Ebserh
        • Contact:
        • Chercheur principal:
          • Monica Maria Gomes da Silva, MD
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brésil, 59075-070
        • Pas encore de recrutement
        • Universidade Federal do Rio Grande do Norte
        • Contact:
        • Chercheur principal:
          • Monica Bay, MD
    • Rio de Janeiro
      • Nova Iguaçu, Rio de Janeiro, Brésil, 26030-380
        • Pas encore de recrutement
        • Hospital Geral de Nova Iguaçu
        • Contact:
        • Chercheur principal:
          • Aline Santos Ramalho Teixeira Benevenuto, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

All persons who are eligible must meet all of the following:

  1. Confirmed HIV-1 infection: All tests must use blood, serum, or plasma samples. Documentation may be obtained from medical records. HIV-1 positive is defined as having HIV-1 RNA in plasma ≥ 1000 copies/mL, plus one antibody test or two positive HIV antibody tests (two different rapid tests or one rapid test and one positive ELISA/EIE test). If any of these diagnostic test results are not available, they will be performed at the SCR visit. In all cases, an HIV viral load test will be performed.
  2. Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
  3. Ability to sign the informed consent form.
  4. Plasma HIV-1 RNA ≥1000 copies/mL. Viral load from the last 30 days may be valid. . Age ≥ 16 years or older in Argentina, ≥ 15 years or older in Brazil. The participant must be of the age required in their country of residence to give legal informed consent. Otherwise, informed consent must be signed by a parent or legal guardian, according to country guidelines, in addition to the participant.

6. Pregnant at any gestational age up to 32 weeks at the time of the screening visit: Viable pregnancy with a gestational age ≤32 weeks, defined according to menstrual history and/or ultrasound. Note: If the menstrual history is unknown or if there is a discrepancy between the menstrual history and the ultrasound, the gestational age will be determined based on the best technology available at each center.

7. The participant intends to continue with the pregnancy.

Exclusion Criteria:

All eligible individuals must NOT meet any of the following criteria:

  1. Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
  2. Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
  3. Hemoglobin <8 g/dL.
  4. Fetal abnormalities detected on ultrasound
  5. Concomitant medications required with possible drug interactions specified in section 5.10.
  6. ALT >=5 times the ULN, or ALT >=3xULN and bilirubin >=1.5xULN (with >35% direct bilirubin). Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification
  7. Presence of severe preeclampsia or other pregnancy-related events, in current or previous pregnancies, such as renal or hepatic abnormalities (grade 2 or higher proteinuria, elevated serum creatinine, CrCl <50 mL/min, total bilirubin, ALT, or AST).
  8. Active opportunistic infection at screening: active severe opportunistic infections and/or severe bacterial infection, including active tuberculosis or severe disease or unstable clinical condition within 14 days prior to study entry.
  9. Any patient or disease-related condition that, in the investigator's opinion, would prevent the patient from adhering to study medication or complying with study visits or procedures.
  10. Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.
  11. Known allergy or sensitivity to any of the study medications or their formulations.
  12. Vomiting or any other reason generating inability to swallow medications due to a pre-existing active disorder that prevents proper swallowing and absorption of study medications.
  13. Creatinine Clearance of <30 mL/min . If a creatinine value was obtained within 30 days prior to the screening visit, it may be used to calculate the CrCl.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental
Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD
Médicament: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]
1 pill QD
Autres noms:
  • BI-THERAPY
Comparateur actif: Active Comparator

TDF/XTC or TAF/FTC plus Dolutegravir (XTC stands for lamivudine OR emtricitabine)

  • TDF/FTC 300/200 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD OR
  • TDF/3TC 300/300 mg, 1 coformulated tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
  • TAF/FTC 25/200 MG, 1 tablet QD (FDC) plus Dolutegravir 50 mg, 1 tablet QD
Médicament: TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
1 pill of each QD
Autres noms:
  • Trithérapie

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
To evaluate the virological response to Dolutegravir/Lamivudine in pregnant women with HIV who are starting antiretroviral therapy and vertical transmission in exposed neonates
Délai: From enrollment to the end of treatment at 6 months after delivery

Endpoints:

  • Proportion of pregnant women who achieve an HIV-1 plasma viral load <200 copies/mL at delivery after starting DTG+3TC (Intention-to-Treat Exposed analysis).
  • Proportion of children born without HIV infection at 6 weeks & 6 months of age, defined by the negative result of negative virological tests (PCR) performed at birth (delivery visit and up to 72 hours after delivery), at 6 weeks, and at 6 months.
From enrollment to the end of treatment at 6 months after delivery

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
- To evaluate the incidence of adverse maternal events.
Délai: From enrollment to the end of treatment at 6 months after delivery
Frequency of grade 2 or higher maternal adverse events, by type and severity, from baseline to 6 months postpartum
From enrollment to the end of treatment at 6 months after delivery
- To evaluate perinatal outcomes at delivery
Délai: From enrollment to the end of treatment at 6 months after delivery
Frequency of spontaneous abortion, preterm delivery, congenital malformations at birth or identified and reported during the first 6 month of life, or intrauterine fetal death.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate maximum virological suppression at delivery
Délai: From enrollment to the end of treatment at 6 months after delivery
Proportion of pregnant women with plasma viral load below 50 copies/mL at delivery.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of changes in body weight exceeding what is expected for gestation
Délai: From enrollment to the end of treatment at 6 months after delivery
Average total weight gain and BMI during pregnancy, compared with recommendations based on pre-pregnancy BMI.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the immune response based on changes in CD4, CD8, and CD4/CD8 ratio values during pregnancy.
Délai: From enrollment to the end of treatment at 6 months after delivery
Changes in CD4 lymphocyte count and CD4/CD8 ratio between baseline and delivery visit values.
From enrollment to the end of treatment at 6 months after delivery
- Assess baseline resistance and the development of resistance to virological failure to integrase inhibitors and INTRs during treatment with DTG+3TC, DTG+TDF/XTC or DTG+TAF/FTC.
Délai: From enrollment to the end of treatment at 6 months after delivery
Frequency and type of mutations according to the International AIDS Society (IAS-USA drug resistance mutations, 2025) mutation guidelines panel at the baseline visit and in case of virological failure at any time during the study.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the incidence of HIV infection in children that breastfeed.
Délai: From enrollment to the end of treatment at 6 months after delivery
Proportion of HIV infection among breastfed children
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 1 of 2.
Délai: From enrollment to the end of treatment at 6 months after delivery
Frequency of grade 2 or higher maternal adverse events, by type and severity, between the two arms.
From enrollment to the end of treatment at 6 months after delivery
To evaluate safety outcomes and virological response of DTG+3TC compared to DTG+TDF/XTC or DTG+TAF/FTC. Part 2 of 2
Délai: From enrollment to the end of treatment at 6 months after delivery
Frequency of pregnant women with plasma viral load <200 copies/mL in the two arms at delivery visit
From enrollment to the end of treatment at 6 months after delivery

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
- To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.
Délai: From enrollment to the end of treatment at 6 months after delivery
Difference in the proportion of pregnant women who achieve an HIV-1 plasma viral load of less than 50 copies/mL at delivery between the DTG+3TC and DTG+TDF/XTC or DTG+TAF/FTC groups, to explore the non-inferiority of the dual regimen.
From enrollment to the end of treatment at 6 months after delivery
- To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.
Délai: From enrollment to the end of treatment at 6 months after delivery
Proportion of participants requiring a change in antiretroviral regimen (due to lack of efficacy, adverse events, medical decision, or other reasons) before delivery
From enrollment to the end of treatment at 6 months after delivery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fundación Huésped

Collaborateurs

ViiV Healthcare

Les enquêteurs

  • Chercheur principal: Pedro Enrinque Cahn, MD, Fundación Huésped

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

10 septembre 2026

Achèvement primaire (Estimé)

15 octobre 2028

Achèvement de l'étude (Estimé)

15 octobre 2028

Dates d'inscription aux études

Première soumission

14 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

1 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FH-94

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Délai de partage IPD

3 month after last patient last visit

Critères d'accès au partage IPD

By request

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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