Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults
Status:
Completed
Trial end date:
2018-04-23
Target enrollment:
Participant gender:
Summary
GSK2838232 is a novel HIV-1 maturation inhibitor (MI) that is being developed for the
treatment of HIV-1 infection in combination with other antiretroviral therapy (ART). This
study will be a 10-day monotherapy, open-label, adaptive, dose ranging, repeat-dose study.
This study will be conducted in two Parts (Part A and Part B) consisting single daily doses
of GSK2838232 and Cobicistat from Day 1 to Day 10. This proof of concept open-label study
will be aimed to characterize the acute antiviral activity, pharmacokinetics (PK), the
relationship between PK and antiviral activity, and safety of GSK2838232/cobi administered
across a range of doses over 10 days in HIV-1 infected patients. A cohort of 10 subjects will
be studied in Part I followed by interim (go/no-go) analysis of Part A data. On completion of
an interim analysis of part A data, further cohorts of 8 subjects will then be studied in
Part B in a parallel design in two or more cohorts (depending upon the data obtained in Part
A). Approximately 34 HIV-1 infected treatment-naive subjects will be enrolled during the
study. Subjects in both parts will have a screening visit within 30 days prior to first dose
and a follow-up visit 7-14 days after the last dose. Maximum duration of study participation
will be approximately 6 Weeks.