NCT02275065已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Bictegravir 5 mg
Experimental
Bictegravir 5 mg (1 × 5 mg tablet) for 10 days
干预措施: Bictegravir (Drug)
Bictegravir 25 mg
Experimental
Bictegravir 25 mg (1 × 25 mg tablet) for 10 days
干预措施: Bictegravir (Drug)
Bictegravir 50 mg
Experimental
Bictegravir 50 mg (2 × 25 mg tablets) for 10 days
干预措施: Bictegravir (Drug)
Bictegravir 100 mg
Experimental
Bictegravir 100 mg (1 × 100 mg tablet) for 10 days
干预措施: Bictegravir (Drug)
Placebo
Placebo Comparator
Placebo matched to bictegravir tablet for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time-Weighted Average Change From Baseline up to Day 11 (DAVG11) in Plasma HIV-1 RNA
时间窗: 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.
次要结局
- 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)
- PK Parameter: CLss/F of Bictegravir Following Multiple-Dose Administration(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10)
- PK/Pharmacodynamic (PD) Analysis: Pearson Correlation Between AUCtau of Bictegravir and DAVG11 in Plasma HIV-1 RNA(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10)
- Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)(First dose date up to last dose date plus 30 days (Maximum: 40 days))
- Pharmacokinetic (PK) Parameter: Cmax of Bictegravir Following Single-Dose and Multiple-Dose Administration(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(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(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1)
- PK Parameter: Ctau of Bictegravir Following Multiple-Dose Administration(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 10)
- PK Parameter: AR_Cmax of Bictegravir Following Multiple-Dose Administration(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10)
- Percentage of Participants Who Experienced Graded Laboratory Abnormalities(First dose date up to last dose date plus 30 days (Maximum: 40 days))
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL(Day 17)
- PK Parameter: AUClast of Bictegravir Following Single-Dose Administration(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(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(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(0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Day 1 and 10)
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