CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life) +3 moredrug
Likely dose
Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05406583
NCT05406583Phase 1Completed
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A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 6, 2022·Updated May 22, 2026

In Brief

A Phase 1 clinical trial evaluating Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), and 2 other interventions for HIV. Completed, enrolled 96 participants across 15 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesSouth Africa, Thailand, United States
CollaboratorsViiV Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJun 6, 2022
Enrollment StartOct 5, 2022
Primary CompletionMar 12, 2025
Study CompletionMay 22, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.1 years ago

Interventions

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

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

Dolutegravir 5 mg Dispersible Tablets (single doses)drug

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

Dolutegravir 5 mg Dispersible Tablets (chronic dose)drug

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

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

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).