NCT05406583

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study will test an anti-HIV drug (ARV) for newborn babies. The study will include a minimum of 36 and up to 108 mothers living with HIV and their newborn babies from Brazil, South Africa, Thailand, and the United States. Infants will be in the study for approximately 16 weeks (four months) after they are born. Mothers will not receive study drug and will exit the study after the Entry visit.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Dolutegravir 0.5 mg/kg oral suspension	DTG 0.5 mg/kg liquid suspension administered orally
DRUG	Dolutegravir 5 mg Dispersible Tablets	DTG 5 mg DT administered orally

Timeline

• Start date: 2022-10-05
• Primary completion: 2025-03-12
• Completion: 2025-05-22
• First posted: 2022-06-06
• Last updated: 2025-08-29

Locations

15 sites across 3 countries: United States, South Africa, Thailand

Regulatory

• FDA-regulated drug study