Dataset from A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic
exposure to combination anti-retroviral therapy identified anti-retroviral associated
long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a
next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection.
This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/
pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will
consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of
GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match
GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1
of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose
level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2)
and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect
(Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could
be modified based on data obtained in Part 1. Subjects will also receive placebo to match
GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a
moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment
period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24).
A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be
randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of
the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.