RecruitingPhase 4NCT07616739

Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women

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


Sponsor

Fundación Huésped

Enrollment

210 participants

Start Date

Sep 10, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] and a drug called TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) for people with hiv-1-infection. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]

1 pill QD

DRUGTDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)

1 pill of each QD


Locations(10)

Hospital General de Agudos Dr. Cosme Argerich

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Güemes

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital de Agudos J.A. Fernandez

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Hospital Nacional Profesor Alejandro Posadas

El Palomar, Buenos Aires, Argentina

Hospital de Agudos Paroissien

Isidro Casanova, Buenos Aires, Argentina

Fundação Bahiana de Infectologia

Salvador, Estado de Bahia, Brazil

Complexo do Hospital de Clínicas da UFPR/Ebserh

Curitiba, Pernambuco, Brazil

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, Brazil

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

RDSS - Ricardo Sobhie Diaz & Cia Solucoes Cientificas Ltda - Ricardo Diaz Scientific Solution

São Paulo, Brazil

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NCT07616739


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