Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
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
1 other identifier
interventional
23
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2014
Shorter than P25 for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2014
CompletedStudy Start
First participant enrolled
October 24, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2015
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedNovember 9, 2020
October 1, 2020
3 months
October 23, 2014
September 8, 2020
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline up to Day 11
Secondary Outcomes (16)
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)
First dose date up to last dose date plus 30 days (Maximum: 40 days)
Percentage of Participants Who Experienced Graded Laboratory Abnormalities
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
Baseline to Day 17
Viral Decay Slope in Plasma HIV-1 RNA
Baseline up to Day 11
Percentage of Participants With HIV-1 RNA < 50 Copies/mL
Day 17
- +11 more secondary outcomes
Study Arms (5)
Bictegravir 5 mg
EXPERIMENTALBictegravir 5 mg (1 × 5 mg tablet) for 10 days
Bictegravir 25 mg
EXPERIMENTALBictegravir 25 mg (1 × 25 mg tablet) for 10 days
Bictegravir 50 mg
EXPERIMENTALBictegravir 50 mg (2 × 25 mg tablets) for 10 days
Bictegravir 100 mg
EXPERIMENTALBictegravir 100 mg (1 × 100 mg tablet) for 10 days
Placebo
PLACEBO COMPARATORPlacebo matched to bictegravir tablet for 10 days
Interventions
Bictegravir tablet(s) administered orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (16)
Unknown Facility
Berkeley, California, United States
Unknown Facility
Davis, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Berkley, Michigan, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Santa Fe, New Mexico, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 27, 2014
Study Start
October 24, 2014
Primary Completion
January 23, 2015
Study Completion
January 29, 2015
Last Updated
November 9, 2020
Results First Posted
October 8, 2020
Record last verified: 2020-10