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Dolutegravir in Pregnant HIV Mothers and Their Neonates

NCT03249181 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2025-02-21

No results posted yet for this study

Summary

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy.

An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (≥28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

Conditions

Interventions

DRUG

Dolutegravir

Patients randomized to the study drug will be commenced on an antiretroviral regimen comprising DTG 50mg once daily in combination with 2 NRTIs

DRUG

Standard of Care (EFV + 2 NRTI backbone)

Patients randomized to receive standard of care will receive the currently used antiretroviral regimens in keeping with national policy.

Sponsors & Collaborators

  • UNITAID

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Infectious Diseases Institute, Uganda

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • University of Liverpool

    lead OTHER

Principal Investigators

  • Saye H Khoo · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-22
Primary Completion
2020-10-20
Completion
2023-09-05

Countries

  • South Africa
  • Uganda

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 NCT03249181 on ClinicalTrials.gov