Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
Completed · Phase 1
Conditions studied: HIV
In brief
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index \[BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m\^2)\] with a participant in the control group.
Key facts
- Study ID
- NCT02400307
- Run by
- Gilead Sciences
- People needed
- 19
- Starts
- 2015-04-17
- Expected to finish
- 2015-07-13
- Last updated by the study team
- 2019-10-11
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
Where it is running
- Avail Clinical Research — DeLand, Florida, United States
- Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Prism Clinical Research — Saint Paul, Minnesota, United States
- New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
- Auckland Clinical Studies Limited — Grafton, Auckland, New Zealand
- Christchurch Clinical Studies Trust — Christchurch, New Zealand
Full record on ClinicalTrials.gov
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