NCT05660980View on ClinicalTrials.gov

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 24, 2024

Primary Completion Date

June 15, 2026

Study Completion Date

July 27, 2027

Conditions
HIV-1-infection
Interventions
DRUG

Once daily CAB tablet + RPV tablet

Tablet

DRUG

Long acting CAB injectable + long acting RPV injectable

Injectable

DRUG

Long acting CAB injectable + long acting RPV injectable

Injectable

Trial Locations (12)

1863

ACTIVE_NOT_RECRUITING

Site 8051, Wits RHI Shandukani Research Centre CRS, Johannesburg

2091

ACTIVE_NOT_RECRUITING

CRS 8052, Soweto IMPAACT, Johannesburg

4066

ACTIVE_NOT_RECRUITING

Site 30300 Umlazi CRS Site, Umlazi

10700

ACTIVE_NOT_RECRUITING

Siriraj Hospital, Mahidol University NICHD CRS (Site #5115), Bangkok

30322

RECRUITING

Site 5030, Emory University School of Medicine NICHD CRS, Atlanta

38105

RECRUITING

Site 6501, St. Jude Children's Research Hospital CRS, Memphis

50202

ACTIVE_NOT_RECRUITING

CRS 31784, Chiang Mai University HIV Treatment CRS, Chiang Mai

57000

ACTIVE_NOT_RECRUITING

Site 5116, PHPT-Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Rai

Unknown

ACTIVE_NOT_RECRUITING

Site 12701, Gaborone CRS, Gaborone

ACTIVE_NOT_RECRUITING

Site 12702, Molepolole CRS, Gaborone

30130-100

ACTIVE_NOT_RECRUITING

Site 5073, SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte

21941-590

ACTIVE_NOT_RECRUITING

CRS 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site, Rio de Janeiro

All Listed Sponsors
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