HIV-1 InfectionPhase 1NCT02275065

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

A Phase 1 study testing Bictegravir in people with HIV-1 Infection, run by Gilead Sciences at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of the study is to investigate the short-term antiviral potency of bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV-1 Infection
What is being tested?: Bictegravir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 16 sitesUnited States
Study dates: 24 Oct 2014to 29 Jan 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Who cannot join

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Study site
Atlanta, Georgia
Study site
Berkeley, California
Study site
Berkley, Michigan
Study site
Dallas, Texas
Study site
Davis, California
Study site
Fort Lauderdale, Florida
Study site
Long Beach, California
Study site
Los Angeles, California
Study site
Newark, New Jersey
Study site
Orlando, Florida
Study site
San Francisco, California
Study site
Santa Fe, New Mexico
Study site
Seattle, Washington
Study site
Vero Beach, Florida
Study site
Washington D.C., District of Columbia
Study site
West Palm Beach, Florida

Other trials in United States

About this study

Official title: A Phase 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects

Conditions: HIV-1 Infection
Being tested: Bictegravir, Placebo
Keywords: HIV-1 Infected, Adults, Treatment Naive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BictegravirDrug
Bictegravir tablet(s) administered orally once daily
PlaceboDrug
Placebo to match bictegravir administered orally once daily

Study groups in NCT02275065
Study group	Role	What they receive
Bictegravir 5 mg	Experimental	Bictegravir 5 mg (1 × 5 mg tablet) for 10 days Receives: Drug: Bictegravir
Bictegravir 25 mg	Experimental	Bictegravir 25 mg (1 × 25 mg tablet) for 10 days Receives: Drug: Bictegravir
Bictegravir 50 mg	Experimental	Bictegravir 50 mg (2 × 25 mg tablets) for 10 days Receives: Drug: Bictegravir
Bictegravir 100 mg	Experimental	Bictegravir 100 mg (1 × 100 mg tablet) for 10 days Receives: Drug: Bictegravir
Placebo	Placebo comparator	Placebo matched to bictegravir tablet for 10 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA
DAVG11 was defined as the time-weighted average between the first postbaseline value through the last available on-treatment (ie, the last dose date + 1) value up to Day 11 minus the baseline value in plasma HIV-1 RNA (log10 copies/mL). All HIV-1 RNA data up to Day 11 were used for this analysis. DAVG11 was calculated using the trapezoidal rule and the area-under-the-curve concept.
Measured: Baseline up to Day 11

Secondary outcomes (16)

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
Measured: First dose date up to last dose date plus 30 days (Maximum: 40 days)
Percentage of Participants Who Experienced Graded Laboratory Abnormalities
A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 toxicity grade from predose assessment and occurring after the predose visit and on or before the date of the last dose of study drug plus 30 days. If the predose assessment was missing, then any abnormality of at least Grade 1 associated with the study drug was considered a treatment-emergent graded laboratory abnormality. The most severe graded abnormality from all tests was counted for each participant.
Measured: First dose date up to last dose date plus 30 days (Maximum: 40 days)
Maximum Reduction From Baseline Through Day 17 in Plasma HIV-1 RNA
Maximum reduction from baseline was defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).
Measured: Baseline to Day 17
Viral Decay Slope in Plasma HIV-1 RNA
Viral Decay Slope = (log10 [HIV-1 RNA on Day x] - log10 [HIV-1 RNA on Day 1]) / (x-1), where x is the collection day of the last available on treatment HIV-1 RNA collected up to Day 7.
Measured: Baseline up to Day 11
Percentage of Participants With HIV-1 RNA < 50 Copies/mL
Measured: Day 17
Pharmacokinetic (PK) Parameter: Cmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
Cmax is defined as the maximum concentration of drug.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
PK Parameter: Tmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
Tmax is defined as the time (observed time point) of Cmax.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
PK Parameter: AUC0-24 of Bictegravir Following Single-Dose Administration
AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
PK Parameter: AUClast of Bictegravir Following Single-Dose Administration
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
PK Parameter: AUCtau of Bictegravir Following Multiple-Dose Administration
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: t1/2 of Bictegravir Following Multiple-Dose Administration
t1/2 is defined as the estimate of the terminal elimination half-life of the drug.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: Ctau of Bictegravir Following Multiple-Dose Administration
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: CLss/F of Bictegravir Following Multiple-Dose Administration
CLss/F is defined as the apparent oral clearance following multiple-dose administration of the drug.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: AR_AUC of Bictegravir Following Multiple-Dose Administration
Accumulation ratio of AUC (AR_AUC) = AUCtau on Day 10 / AUC0-24 on Day 1. Percentage of accumulation ratio has been reported.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
PK Parameter: AR_Cmax of Bictegravir Following Multiple-Dose Administration
Accumulation ratio of Cmax (AR_Cmax) = Cmax on Day 10 / Cmax on Day 1. Percentage of accumulation ratio has been reported.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
PK/Pharmacodynamic (PD) Analysis: Pearson Correlation Between AUCtau of Bictegravir and DAVG11 in Plasma HIV-1 RNA
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). DAVG11 was defined as the time-weighted average between the first postbaseline value through the last available on-treatment (ie, the last dose date + 1) value up to Day 11 minus the baseline value in plasma HIV-1 RNA (log10 copies/mL).
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201429 Jan 2015

First posted27 Oct 2014 (estimated)
Study start24 Oct 2014
Primary completion23 Jan 2015
Study completion29 Jan 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 HIV-1 InfectionStudies 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: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02275065
Sponsor's protocol ID: GS-US-141-1219
Status last verified: Oct 2020
First submitted: 23 Oct 2014
Last updated: 9 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Randomized, Double-Blinded, Sequential Cohort Placebo-Controlled Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-9883 in HIV-1 Infected Subjects
ClinicalTrials.gov ID: NCT02275065
Acronym / sponsor ID: GS-US-141-1219
Conditions: HIV-1 Infection
Keywords: HIV-1 Infected, Adults, Treatment Naive
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 24 Oct 2014 (actual)
Primary completion: 23 Jan 2015 (actual)
Study completion: 29 Jan 2015 (actual)
First posted: 27 Oct 2014 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Bictegravir 5 mg	Experimental	Drug: BictegravirBictegravir 5 mg (1 × 5 mg tablet) for 10 days
Bictegravir 25 mg	Experimental	Drug: BictegravirBictegravir 25 mg (1 × 25 mg tablet) for 10 days
Bictegravir 50 mg	Experimental	Drug: BictegravirBictegravir 50 mg (2 × 25 mg tablets) for 10 days
Bictegravir 100 mg	Experimental	Drug: BictegravirBictegravir 100 mg (1 × 100 mg tablet) for 10 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo matched to bictegravir tablet for 10 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key exclusion criteria (7 listed)

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection

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
BictegravirBictegravir tablet(s) administered orally once daily	Drug	Bictegravir 100 mg, Bictegravir 25 mg, Bictegravir 5 mg, Bictegravir 50 mg
PlaceboPlacebo to match bictegravir administered orally once daily	Drug	Placebo

Primary outcome

Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA
Time frame: Baseline up to Day 11
DAVG11 was defined as the time-weighted average between the first postbaseline value through the last available on-treatment (ie, the last dose date + 1) value up to Day 11 minus the baseline value in plasma HIV-1 RNA (log10 copies/mL). All HIV-1 RNA data up to Day 11 were used for this analysis. DAVG11 was calculated using the trapezoidal rule and the area-under-the-curve concept.

16 secondary outcomes

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
Time frame: First dose date up to last dose date plus 30 days (Maximum: 40 days)
Percentage of Participants Who Experienced Graded Laboratory Abnormalities
Time frame: First dose date up to last dose date plus 30 days (Maximum: 40 days)
Maximum Reduction From Baseline Through Day 17 in Plasma HIV-1 RNA
Time frame: Baseline to Day 17
Viral Decay Slope in Plasma HIV-1 RNA
Time frame: Baseline up to Day 11
Percentage of Participants With HIV-1 RNA < 50 Copies/mL
Time frame: Day 17
Pharmacokinetic (PK) Parameter: Cmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
PK Parameter: Tmax of Bictegravir Following Single-Dose and Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 for single dose and Day 10 for multiple dose
PK Parameter: AUC0-24 of Bictegravir Following Single-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
PK Parameter: AUClast of Bictegravir Following Single-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1
PK Parameter: AUCtau of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: t1/2 of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: Ctau of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: CLss/F of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10
PK Parameter: AR_AUC of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
PK Parameter: AR_Cmax of Bictegravir Following Multiple-Dose Administration
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10
PK/Pharmacodynamic (PD) Analysis: Pearson Correlation Between AUCtau of Bictegravir and DAVG11 in Plasma HIV-1 RNA
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bictegravir 5 mg	5	4
Bictegravir 25 mg	4	4
Bictegravir 50 mg	5	4
Bictegravir 100 mg	5	4
Placebo	4	4

Primary outcome: Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA

Time frame: Baseline up to Day 11. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	Bictegravir 5 mg n = 3	Bictegravir 25 mg n = 4	Bictegravir 50 mg n = 4	Bictegravir 100 mg n = 4	Placebo n = 4
Baseline	4.26 (0.157)	4.64 (0.498)	4.42 (0.458)	4.71 (1.040)	4.50 (0.407)
Change at Day 11	-0.92 (0.104)	-1.33 (0.174)	-1.37 (0.310)	-1.61 (0.256)	-0.01 (0.144)

Bictegravir 5 mg vs Placebo: p <0.001, t-test, 2 sided
Bictegravir 25 mg vs Placebo: p <0.001, t-test, 2 sided
Bictegravir 50 mg vs Placebo: p <0.001, t-test, 2 sided

Population analysed: The Per-Protocol Analysis Set included all randomized participants who took at least 1 dose of bictegravir with baseline HIV-1 RNA ≥ 1900 copies/mL, which allowed up to 2 log decreases in HIV-1 RNA.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date up to last dose date plus 30 days (Maximum: 40 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bictegravir 5 mg	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Bictegravir 25 mg	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Bictegravir 50 mg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Bictegravir 100 mg	0 of 4 (0%)	2 of 4 (50%)	0 of 4
Placebo	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for HIV-1 Infection

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Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
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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

16 sites in 1 country: 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-1 Infection, run by Gilead Sciences at 16 sites in United States.

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 3 inclusion and 7 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 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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. Some participants in this study may receive a placebo. 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 8 Oct 2020). 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?

Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA (time frame: Baseline up to Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275065.

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 9 Nov 2020.