GSK1349572 Drug Interaction Study With Fosamprenavir/Ritonavir
Condition: Infections, Human Immunodeficiency Virus and Herpesviridae
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1349572 is an integrase inhibitor being developed for the treatment of human
      immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV
      HealthcareLLC. In HIV-infected patients where combination antiretroviral therapy is the
      standard of care, it is likely that it will be dosed with boosted protease inhibitors (PIs)
      including fosamprenavir/ritonavir (FPV/RTV or FPV/r). As FPV and RTV are modulators
      (induction as well as inhibition) of Uridine diphosphate glucuronosyltransferase (UGT) and
      Cytochrome P450 (CYP)3A which are the primary and secondary metabolic pathways of GKS1349572,
      it is likely that FPV/RTV will affect the pharmacokinetics (PK) of GSK1349572, therefore a
      drug interaction study is warranted and will be evaluated in Part A of this study. Part B
      will evaluate the effect of particle size of tablet variants on the PK of GSK1349572.

      In Part A, approximately 12 subjects will receive GSK1349572 50mg every 24 hours (q24h) for 5
      days (Treatment A). Subjects will then be administered GSK1349572 50mg q24h in combination
      with FPV/RTV 700/100 mg every 12 hours (q12h) (Treatment B) for 10 days. There will be no
      washout between treatments. In Part B 15 subjects will receive a single 50 mg dose (2 x 25mg
      tablet) in 3 different tablet variants of the same formulation, differing only in particle
      sizes of GSK1349572, under fasted conditions in a three-way crossover design. Safety
      evaluations and serial PK samples will be collected during each treatment period. A follow-up
      visit will occur 7-14 days after the last dose of study drug.
    

Detailed description: 
      Official Study Title: Phase I, open label, two period, study to evaluate the effects of
      fosamprenavir/ritonavir on GSK1349572 pharmacokinetics and a phase I, randomized, three-way
      crossover study to evaluate the relative bioavailability of three tablet variants made using
      micronized, unmicronized and intermediate particle sizes of GSK1349572 in healthy adult
      subjects (ING113068).

      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship
    

Intervention name(s): GSK1349572; Fosamprenavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus -1 infection by ViiV Healthcare. This drug is experimental and has not been approved by the Food and Drug Administration (FDA).; Fosamprenavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.; Ritonavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.
Other intervention name(s): TELZIR; LEXIVA; GW433908; NORVIR
Intervention MeSH terms: Ritonavir; Fosamprenavir; Dolutegravir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: integrase; fosamprenavir; ritonavir; GSK1349572