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

HIV Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05406583
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact Sarah Bradford, MPH
Phone 1-919-321-3673
Email SBradford@fhi360.org
Status Recruiting
Phase Phase 1
Start date October 5, 2022
Completion date February 28, 2025
View Details
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