Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

September 30, 2028

Conditions
HIV Infections With Multi Drug Resistant Virus
Interventions
DRUG

Fostemsavir

fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance

Trial Locations (10)

2112

RECRUITING

Rahima Moosa Mother and Child Hospital, Johannesburg

20010

RECRUITING

The George Washington University, Children's National Health System, Washington D.C.

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

Unknown

NOT_YET_RECRUITING

Hospital Geral de Nova Iguaçu, Nova Iguaçu

RECRUITING

FAM-CRU, Cape Town

RECRUITING

King Edward VIII Hospital, Durban

RECRUITING

Wits Reproductive Health and HIV Institutel, Johannesburg

RECRUITING

PHRU, Soweto

20221-161

NOT_YET_RECRUITING

Hospital Federal dos Servidores do Estado, Rio de Janeiro

0008

NOT_YET_RECRUITING

Kalafong Hospital, Pretoria

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

collaborator

PHPT Foundation

UNKNOWN

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Cromsource

INDUSTRY

lead

PENTA Foundation

NETWORK