Phase 1
N=19
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
HIV
Bottom Line
View on ClinicalTrials.gov: NCT02400307 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) — 138169.7; 170105.6 h*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bictegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) |
138169.7; 170105.6 | — |
| PRIMARY PK Parameter: AUCinf of Bictegravir (Free) |
830.6; 824.5 | — |
| PRIMARY PK Parameter: AUClast of Bictegravir (Total) |
136956.4; 168876.8 | — |
| PRIMARY PK Parameter: AUClast of Bictegravir (Free) |
822.5; 818.6 | — |
| PRIMARY PK Parameter: Cmax of Bictegravir (Total) |
5977.0; 7227.5 | — |
| PRIMARY PK Parameter: Cmax of Bictegravir (Free) |
37.7; 35.0 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events |
20.0; 25.0 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities |
20.0; 25.0; 40.0; 25.0; 40.0; 0 | — |
Summary
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.
Eligibility Criteria
Key Inclusion Criteria
- All Individuals:
- Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening
- Individuals with impaired renal function
- Chronic stable renal impairment without recent clinical change
- Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min
- Moderate: CrCl = 30 - 59 mL/min
- Severe: CrCl = 15 - 29 mL/min
- Healthy individuals
- CrCl ≥ 90 mL/min
Key Exclusion Criteria
- All Individuals:
- Pregnant or lactating females
- HIV positive or chronic hepatitis B infected
- Individuals with impaired renal function
- Chronic liver disease
- Dialysis or anticipated use of dialysis
- Renal transplant
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02400307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.