Activity of the integrase inhibitor S/GSK1349572 in subjects with HIV exhibiting raltegravir resistance: week 24 results of the VIKING study (ING112961)
نویسندگان
چکیده
Background S/GSK1349572(572) showed potent activity in Phase 2 studies in INI-naive HIV-infected subjects and limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. VIKING is an ongoing 24-week Phase 2b pilot study assessing 572 in subjects with RAL-resistant HIV. A good antiviral response during the functional monotherapy phase (through Day 11) of this pilot study was observed with a strong correlation between baseline susceptibility to 572 and response.
منابع مشابه
Novel monitoring technique to minimise the risk for patients participating in pilot studies of investigational compounds
Background S/GSK1349572 is a new integrase inhibitor (INI) with in-vitro activity against INI-resistant HIV. Before dosing a large number of subjects in pivotal clinical trials, in-vitro findings were validated in a pilot clinical study (ING112961). At the outset of the study, the degree of susceptibility at which the drug no longer provides benefit was unknown. Planned enrollment for this stud...
متن کاملSafety and Efficacy of Dolutegravir in Treatment-Experienced Subjects With Raltegravir-Resistant HIV Type 1 Infection: 24-Week Results of the VIKING Study
BACKGROUND Dolutegravir (DTG; S/GSK1349572), a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, has limited cross-resistance to raltegravir (RAL) and elvitegravir in vitro. This phase IIb study assessed the activity of DTG in HIV-1-infected subjects with genotypic evidence of RAL resistance. METHODS Subjects received DTG 50 mg once daily (cohort I) or 50 mg twice daily (cohort...
متن کاملDolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study.
BACKGROUND The Phase III VIKING-3 study demonstrated that dolutegravir (DTG) 50 mg twice daily was efficacious in antiretroviral therapy (ART)-experienced subjects harbouring raltegravir- and/or elvitegravir-resistant HIV-1. VIKING-4 (ING116529) included a placebo-controlled 7-day monotherapy phase to demonstrate that short-term antiviral activity was attributable to DTG. METHODS VIKING-4 is ...
متن کاملIn Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
S/GSK1349572 is a next-generation HIV integrase (IN) inhibitor designed to deliver potent antiviral activity with a low-milligram once-daily dose requiring no pharmacokinetic (PK) booster. In addition, S/GSK1349572 demonstrates activity against clinically relevant IN mutant viruses and has potential for a high genetic barrier to resistance. S/GSK1349572 is a two-metal-binding HIV integrase stra...
متن کاملPK/PD modeling supports the dose-escalation decision in VIKING
In the VIKING study a 50 mg once daily regimen of the next generation HIV integrase inhibitor (INI) S/ GSK1349572 (572) exhibited promising antiviral activity in an initial cohort (Cohort I) of treatment-experienced subjects with documented raltegravir (RAL) resistance. The purpose of this work was to evaluate via simulation techniques whether improved virologic responses could be achieved with...
متن کامل