In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance. It will also assess the acceptability and swallowability of formulation among the pediatric population. The dose selection of FTR for children and adolescents ≥20kg utilized a population pharmacokinetic (POP PK) model-based approach to achieve similar adult TMR exposures following FTR 600mg BID administration with combination therapy that was demonstrated to be safe and effective in the FTR Phase 3 BRIGHTE study in HTE patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Brazil
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Brazil
FAM-CRU
Cape Town, South Africa
King Edward VIII Hospital
Durban, South Africa
Rahima Moosa Mother and Child Hospital
Johannesburg, South Africa
Wits Reproductive Health and HIV Institutel
Johannesburg, South Africa
PHRU
Soweto, South Africa
Occurrence of the following events through Week 24
Time frame: 24 weeks
AUC(0-tau)
Time frame: at week 1, 4, 12, 24, 48
Cmax
Time frame: at week 1, 4, 12, 24, 48
Ctau of temsavir across weight bands
Time frame: at week 1, 4, 12, 24, 48
Proportion of patients with HIV-1 RNA <50 copies/mL
To evaluate the antiviral activity of fostemsavir + OBT
Time frame: at 24 weeks and 48 weeks
Change in log10 HIV-1 RNA from baseline
Time frame: at 24 weeks and 48 weeks
Occurrence of: AEs, treatment-related AEs, AEs of Grade 3 or higher, serious AEs, and AEs leading to premature study treatment discontinuation.
Time frame: at Week 48 and at the end of Study
Occurrence of WHO 3 or 4 defining events, or death
Time frame: up to 156 weeks
efficacy of fostemsavir plus OBT
changes from baseline in CD4+ T cell counts and the percentage of CD4 + T-cells
Time frame: up to 156 weeks
Emergence of genotypic or phenotypic resistance to Temsavir and components of OBT
Time frame: up to 156 weeks
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