Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women

Starting soon · Phase 4

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT07616739

Run by

Fundación Huésped

People needed

210

Starts

2026-06-15

Expected to finish

2028-09-15

Last updated by the study team

2026-06-01

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All persons who are eligible must meet all of the following:
• 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.
• Not exposed to prior antiretroviral therapy (ART): No prior antiretroviral therapy, including exposure to PrEP and/or PEP in the last 6 months.
• Ability to sign the informed consent form.
• 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.
• 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.
• The participant intends to continue with the pregnancy.

You may not qualify if…

• All eligible individuals must NOT meet any of the following criteria:
• Documented resistance to 3TC (presence of the M184V/I mutation) or DTG (defined as the presence of G118R, Q148 H/K/R, or R263K).
• Active hepatitis C infection. 3. Active hepatitis B (HBsAg positive or detectable HBV viral load in cases with isolated positive HBV anti-core).
• Hemoglobin <8 g/dL.
• Fetal abnormalities detected on ultrasound
• Concomitant medications required with possible drug interactions specified in section 5.10.
• 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
• 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).
• 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.
• 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.
• Problematic drug and/or alcohol use, which in the opinion of the site investigator could interfere with therapeutic compliance with study requirements.
• Known allergy or sensitivity to any of the study medications or their formulations.
• 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.
• 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.

Where it is running

• 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, São Paulo, Brazil

Full record on ClinicalTrials.gov

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