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DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women

NCT04808973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-04

No results posted yet for this study

Summary

The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.

Conditions

  • HIV Infections
  • Pregnancy Related
  • Mother to Child Transmission

Interventions

DRUG

Dolutegravir plus lamivudine in a FDC

All participants will receive an ART regimen composed by Lamivudine plus Dolutegravir in a single pill (FDC)

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Fundação Bahiana de Infectologia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-08-31
Completion
2023-09-10

Countries

  • Brazil

Study Locations

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Entities

Companies

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 NCT04808973 on ClinicalTrials.gov