drugset / Trial / NCT05406583
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
Phase 1
Completed
96 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collabViiV Healthcare · collab
Non-randomizedSequentialOpen-labelPrevention
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.
Timeline
- Start
- 2022-10-05
- Primary completion
- 2025-03-12
- Completion
- 2025-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Dolutegravir | Other / unclassified | 5 mg | Oral |