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A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

NCT05406583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-22

Study results available
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Summary

The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1. The primary goal of the study was to propose a dose of DTG that is safe and meets PK targets when administered to infants through the first four weeks of life in addition to the infant's standard HIV-1 ARV prophylaxis. The study was expected to enroll a minimum of 36 and up to 108 mother-infant (M-I) pairs from Brazil, South Africa, Thailand, and the United States. Infants were followed through 16 weeks of life. Mothers did not receive study drug and were off study after completion of the Entry visit. A total of 48 M-I pairs were enrolled in the study.

Conditions

Interventions

DRUG

Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)

DTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days). Mothers do not receive any drug

DRUG

Dolutegravir 5 mg Dispersible Tablets (single doses)

DTG 5 mg dispersible tablets administered orally once at Entry visit (0-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days) Mothers do not receive any drug

DRUG

Dolutegravir 5 mg Dispersible Tablets (chronic dose)

DTG 5 mg dispersible tablets administered orally every 48 hours from the Entry visit (0-5 days of life) through Day 13 (week 2) of life; then every 24 hours from Day 14 of life through the Week 4 or Week 6 visit based on the duration of local standard ARV prophylaxis at each site Mothers do not receive any drug

DRUG

Dolutegravir 0.5 mg/kg liquid suspension (starts at 2-5 days of life)

DTG 0.5 mg/kg liquid suspension administered orally once at Entry visit (2-5 days of life) and again at 7 Days Post Initial Dose visit (+3 days).

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Diana Clarke, Pharm.D. · Boston Medical Center/ Section of Pediatric Infectious Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2025-03-12
Completion
2025-05-22
FDA Drug
Yes

Countries

  • United States
  • South Africa
  • Thailand

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 NCT05406583 on ClinicalTrials.gov