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- Open Access
Once-daily S/GSK1349572 combination therapy in antiretroviral-naïve adults: rapid and potent 24-week antiviral responses in SPRING-1 (ING112276)
© Rockstroh et al; licensee BioMed Central Ltd. 2010
Published: 8 November 2010
Purpose of study
S/GSK1349572, a next-generation HIV-1 integrase inhibitor, has previously demonstrated potent antiviral activity in Phase 2a with once-daily, unboosted dosing. SPRING-1 is an ongoing dose-ranging study designed to select a dose to for Phase 3 evaluation.
SPRING-1 is a Phase 2b, multicentre, partially-blinded study in therapy-naïve adults, randomized 1:1:1:1 to 10mg, 25mg or 50mg of S/GSK1349572 or efavirenz(EFV) 600mg once-daily with either co-formulated TDF/FTC or ABC/3TC.
Summary of results
Planned Week 24 Interim Analysis Results
S/GSK1349572 10 mg (n=53)
S/GSK1349572 25mg (n=51)
S/GSK1349572 50mg (n=51)
EFV control (n=50)
Mean baseline HIV-1 RNA (log10 c/mL)
%<50c/mL at 24 wks (by TLOVR)
Median baseline (change from baseline at 24 weeks) CD4+ cells/mm3
S/GSK1349572 administered once-daily without a PK booster was well tolerated with potent antiviral activity at all doses explored in SPRING-1. The greater CD4+ cell increases on S/GSK1349572 merit further observation and confirmation.
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