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

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 5, 2022

Primary Completion Date

March 12, 2025

Study Completion Date

May 22, 2025

Conditions
HIV
Interventions
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

Trial Locations (15)

1864

Soweto, Johannesburg

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

4013

Umlazi, Durban

7500

FAMCRU, Cape Town

10457

Bronx-Lebanon Hospital Center NICHD CRS, The Bronx

10700

Siriraj Hospital, Mahidol University NICHD CRS, Bangkok

30322

Emory University School of Medicine NICHD CRS, Atlanta

50200

Chiang Mai University HIV Treatment, Chiang Mai

57000

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Rai

60612

Rush University, Cook County Hospital NICHD CRS, Chicago

77030

Baylor College of Medicine/ Texas Children's Hospital NICHD CRS, Houston

80045

University of Colorado Denver NICHD CRS, Aurora

90033-1075

USC - Maternal Child Adolescent/Adult Center, Los Angeles

90095-1752

David Geffen School of Medicine at UCLA NICHD CRS, Los Angeles

38105-3678

St. Jude Children's Research Hospital, Memphis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

collaborator

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

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT05406583 - A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1 | Biotech Hunter | Biotech Hunter