GSK1349572 Exposure in Blood, Cervicovaginal Fluid, and Cervical and Vaginal Tissue in Healthy Female Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

September 30, 2012

Conditions
Healthy Adult Females
Interventions
DRUG

GSK1349572 (dolutegravir)

Subjects will take an oral daily 50mg dose of GSK1349572 for 5-7 days. GSK1349572 in the CVF and BP will be measured over 24 hours after both the initial dose, and once steady state is reached 5-7 days later at the following time points: 0 (pre-dose) 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24h. Cervical and vaginal biopsies will be collected once at initial dose at either 3, 6, 12 or 24 hours post dose, and again at steady state at the same single time point. Samples will be collected from 2 subjects per time point. BP and CVF samples will be obtained at 48 and 72 hours following the final GSK1349572 dose.

Trial Locations (1)

27599

University of North Carolina, Chapel Hill, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER