Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2019-07-25
Target enrollment:
Participant gender:
Summary
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus
(HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and
infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical
sites associated with sexual HIV transmission following the proposed 600 milligram (mg)
intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB
distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1
transmission and supplement the data to support future PrEP clinical trial development. The
primary objective is to determine the PK concentrations of CAB following LA administration in
plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in
healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women
following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy
subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations
associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of
a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a
14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal)
injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will
return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection
and undergo a follow-up/withdrawal visit at Week 52 post-injection.