Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Status:Planned
Phase:I
Principal Investigator(s):GSK Clinical Trials, ViiV Healthcare
Objective: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 800 milligram (mg) intramuscular PrEP dose are unknown. These data will enhance further our understanding of CAB distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1 transmission and supplement the data available to support future PrEP clinical trial development. The primary objective is to determine the PK concentrations of CAB following LA administration in blood 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 800 mg IM (split injection) dose.
Prevention Option(s):PrEP
Study Design:Open label
Official Code:
NCT02478463
Trial Sponsors:
ViiV Healthcare
Start Date
End Date
April 19, 2016
June 19, 2017
Enrollment:16
Age range:
18 Years ↔
55 Years
Population:Cisgender Men, Cisgender Women