The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

September 9, 2020

Primary Completion Date

December 14, 2021

Study Completion Date

May 31, 2022

Conditions
HIV Infections
Interventions
DRUG

Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets

Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food

DRUG

Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)

Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food

Trial Locations (14)

1862

Soweto IMPAACT CRS, Johannesburg

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

4066

Umlazi CRS, Umlazi

7505

Famcru Crs, Tygerberg

10700

Siriraj Hospital, Mahidol University NICHD CRS, Bangkok

50100

Chiangrai Prachanukroh Hospital NICHD CRS, Changklan, Muang

50200

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS, Chiang Mai

60612

Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago

80045

Univ. of Colorado Denver NICHD CRS, Aurora

90095-1752

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

60614-3393

Lurie Children's Hospital of Chicago (LCH) CRS, Chicago

38105-3678

St. Jude Children's Research Hospital CRS, Memphis

Unknown

Gaborone CRS, Gaborone

Molepolole CRS, Gaborone

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

collaborator

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

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

ViiV Healthcare

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age | Biotech Hunter | Biotech Hunter