HIVPhase 1NCT02400307
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
A Phase 1 study testing Bictegravir in people with HIV, run by Gilead Sciences at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Bictegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 17 Apr 2015to 13 Jul 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Severe: CrCl = 15 - 29 mL/min
- Healthy individuals
- CrCl ≥ 90 mL/min
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Avail Clinical Research
DeLand, Florida, 32720
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
Prism Clinical Research
Saint Paul, Minnesota, 55114
New Zealand2 sites
Christchurch Clinical Studies Trust
Christchurch, 8011
Auckland Clinical Studies Limited
Grafton, Auckland, 1010
About this study
Official title: A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function
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.
- Conditions
- HIV
- Being tested
- Bictegravir
- Keywords
- Phase 1, Renally Impaired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BictegravirDrug
Also called GS-9883
75 mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Severe Renal Impairment | Experimental | Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir. Receives: Drug: Bictegravir |
| Moderate Renal Impairment | Experimental | Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir. Receives: Drug: Bictegravir |
| Mild Renal Impairment | Experimental | Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir. Receives: Drug: Bictegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
PK Parameter: AUCinf of Bictegravir (Free)
Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
PK Parameter: AUClast of Bictegravir (Total)
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
PK Parameter: AUClast of Bictegravir (Free)
Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
PK Parameter: Cmax of Bictegravir (Total)
Cmax is defined as the maximum observed plasma concentration of drug.
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
PK Parameter: Cmax of Bictegravir (Free)
Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
Measured: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Secondary outcomes (2)
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Measured: First dose date to Day 31
Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening.
Measured: First dose date to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start17 Apr 2015
- Primary completion6 Jul 2015
- Study completion13 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400307
- Sponsor's protocol ID
- GS-US-141-1479
- Other IDs
- 2015-000898-12, 2015
- Status last verified
- Sep 2019
- First submitted
- 17 Mar 2015
- Last updated
- 11 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function
- ClinicalTrials.gov ID
- NCT02400307
- Acronym / sponsor ID
- GS-US-141-1479
- Conditions
- HIV
- Keywords
- Phase 1, Renally Impaired
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 6 Jul 2015 (actual)
- Study completion
- 13 Jul 2015 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Renal Impairment | Experimental | Drug: BictegravirParticipants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir. |
| Moderate Renal Impairment | Experimental | Drug: BictegravirParticipants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir. |
| Mild Renal Impairment | Experimental | Drug: BictegravirParticipants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All Individuals:
- Individuals with impaired renal function
- Healthy individuals
Key exclusion criteria (8 listed)
- All Individuals:
- Individuals with impaired renal function
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BictegravirAlso: GS-988375 mg tablet administered orally | Drug | Mild Renal Impairment, Moderate Renal Impairment, Severe Renal Impairment |
Primary outcome
Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
PK Parameter: AUCinf of Bictegravir (Free)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
PK Parameter: AUClast of Bictegravir (Total)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
PK Parameter: AUClast of Bictegravir (Free)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
PK Parameter: Cmax of Bictegravir (Total)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Cmax is defined as the maximum observed plasma concentration of drug.
PK Parameter: Cmax of Bictegravir (Free)
Time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
2 secondary outcomes
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
Time frame: First dose date to Day 31
Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date to Day 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bictegravir in people with HIV, run by Gilead Sciences at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total) (time frame: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.