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Completed

NCT Number: NCT02275065

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

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berkeley, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bictegravir

Drug

Bictegravir tablet(s) administered orally once daily

Placebo

Drug

Placebo to match bictegravir administered orally once daily

Primary outcomes

  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 outcomes

  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 (i.e. smallest change in HIV-RNA from baseline).

  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).

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 27, 2014
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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