Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women

NCT07616739 | Not Yet Recruiting Phase 4

• 1 other identifier: FH-94
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

HIV-1-infection

Keywords

antiretroviral naive triple therapy; Dolutegravir-Lamivudine dual-therapy

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (9)

• - To evaluate the incidence of adverse maternal events.

  From enrollment to the end of treatment at 6 months after delivery

• - To evaluate perinatal outcomes at delivery

  From enrollment to the end of treatment at 6 months after delivery

• - To evaluate maximum virological suppression 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

  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.

  From enrollment to the end of treatment at 6 months after delivery

Other Outcomes (2)

• - To explore the non-inferiority of DTG+3TC therapy compared to DTG+TDF/XTC or DTG+TAF/FTC treatment.

  From enrollment to the end of treatment at 6 months after delivery

• - To evaluate the frequency of antiretroviral therapy withdrawal or modification before delivery.

  From enrollment to the end of treatment at 6 months after delivery

Study Arms (2)

Experimental

EXPERIMENTAL

Dolutegravir plus Lamivudine DOVATO: Dolutegravir 50mg/lamivudine 300 mg, FDC, 1 coformulated tablet QD

Drug: Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]

Active Comparator

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

Drug: TDF/XTC or TAF/FTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)

Interventions

Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO] DRUG

1 pill QD

Also known as: BI-THERAPY

Experimental

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

1 pill of each QD

Also known as: Triple therapy

Active Comparator

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fundación Huésped: lead
• ViiV Healthcare: collaborator

Study Sites (10)

Hospital General de Agudos Dr. Cosme Argerich

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1155AHD, Argentina

Location

Sanatorio Güemes

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1188AAF, Argentina

Location

Hospital de Agudos J.A. Fernandez

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425AGP, Argentina

Location

Hospital Nacional Profesor Alejandro Posadas

El Palomar, Buenos Aires, B1684, Argentina

Location

Hospital de Agudos Paroissien

Isidro Casanova, Buenos Aires, B1765, Argentina

Location

Fundação Bahiana de Infectologia

Salvador, Estado de Bahia, 40110-160, Brazil

Location

Complexo do Hospital de Clínicas da UFPR/Ebserh

Curitiba, Pernambuco, 80430-000, Brazil

Location

Hospital Geral de Nova Iguaçu

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

Location

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, 59075-070, Brazil

Location

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

São Paulo, São Paulo, 04037-030, Brazil

Location

MeSH Terms

Interventions

dolutegravir; Lamivudine; Emtricitabine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Pedro Enrinque Cahn, MD

  Fundación Huésped

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Inés Figueroa, MD

CONTACT

+541149817777; maria.figueroa@huesped.org.ar

Emanuel Dell'Isola, Mr.

CONTACT

+541149817777; emanuel.dellisola@huesped.org.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: June 1, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 month after last patient last visit
• Access Criteria: By request

Locations

AR (5); BR (5)