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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275065
Recruitment Status : Completed
First Posted : October 27, 2014
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Bictegravir Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 24, 2014
Actual Primary Completion Date : January 23, 2015
Actual Study Completion Date : January 29, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Bictegravir 5 mg
Bictegravir 5 mg (1 × 5 mg tablet) for 10 days
Drug: Bictegravir
Bictegravir tablet(s) administered orally once daily

Experimental: Bictegravir 25 mg
Bictegravir 25 mg (1 × 25 mg tablet) for 10 days
Drug: Bictegravir
Bictegravir tablet(s) administered orally once daily

Experimental: Bictegravir 50 mg
Bictegravir 50 mg (2 × 25 mg tablets) for 10 days
Drug: Bictegravir
Bictegravir tablet(s) administered orally once daily

Experimental: Bictegravir 100 mg
Bictegravir 100 mg (1 × 100 mg tablet) for 10 days
Drug: Bictegravir
Bictegravir tablet(s) administered orally once daily

Placebo Comparator: Placebo
Placebo matched to bictegravir tablet for 10 days
Drug: Placebo
Placebo to match bictegravir administered orally once daily




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
  2. Percentage of Participants Who Experienced Graded Laboratory Abnormalities [ Time Frame: First dose date up to last dose date plus 30 days (Maximum: 40 days) ]
    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.

  3. Maximum Reduction From Baseline Through Day 17 in Plasma HIV-1 RNA [ Time Frame: Baseline to Day 17 ]
    Maximum reduction from baseline was defined as the minimum of change from baseline in plasma HIV-1 RNA.

  4. Viral Decay Slope in Plasma HIV-1 RNA [ Time Frame: Baseline up to Day 11 ]
    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.

  5. Percentage of Participants With HIV-1 RNA < 50 Copies/mL [ Time Frame: Day 17 ]
  6. 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 ]
    Cmax is defined as the maximum concentration of drug.

  7. 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 ]
    Tmax is defined as the time (observed time point) of Cmax.

  8. 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 ]
    AUC0-24 is defined as the concentration of drug over time from time zero to time 24 hours.

  9. 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 ]
    AUClast is defined as the concentration of drug from time zero to the last observable concentration.

  10. 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 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

  11. 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 ]
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug.

  12. 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 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval.

  13. 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 ]
    CLss/F is defined as the apparent oral clearance following multiple-dose administration of the drug.

  14. 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 ]
    Accumulation ratio of AUC (AR_AUC) = AUCtau on Day 10 / AUC0-24 on Day 1. Percentage of accumulation ratio has been reported.

  15. 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 ]
    Accumulation ratio of Cmax (AR_Cmax) = Cmax on Day 10 / Cmax on Day 1. Percentage of accumulation ratio has been reported.

  16. 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 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275065


Locations
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United States, California
Berkeley, California, United States
Davis, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Francisco, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Fort Lauderdale, Florida, United States
Orlando, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Michigan
Berkley, Michigan, United States
United States, New Jersey
Newark, New Jersey, United States
United States, New Mexico
Santa Fe, New Mexico, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02275065    
Other Study ID Numbers: GS-US-141-1219
First Posted: October 27, 2014    Key Record Dates
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
HIV-1 Infected
Adults
Treatment Naive