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Dolutegravir/Lamivudine in Treatment-Naïve Pregnant Women

NCT07616739 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-06-01

No results posted yet for this study

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

Interventions

DRUG

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

1 pill QD

DRUG

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

1 pill of each QD

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Pedro Enrinque Cahn, MD · Fundación Huésped

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-07-15
Completion
2028-09-15

Countries

  • Argentina
  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07616739 on ClinicalTrials.gov