A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Incidence of Treatment-Emergent Serious Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to < 18 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
- •Weight ≥ 35 kg (77 lbs.)
- •Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months
- •CD4+ cell count > 100 cells/μL
- •No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
- •Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- •No evidence of current hepatitis B virus (HBV) infection
- •No evidence of current hepatitis C virus (HCV) infection
- •Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.
排除标准
- •A new AIDS-defining condition diagnosed within the 30 days prior to Screening
- •Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
- •Pregnant or lactating subjects
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
E/C/F/TAF
Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks.
After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country.
干预措施: E/C/F/TAF (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Serious Adverse Events
时间窗: Up to Week 48
The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to Week 48
The percentage of participants experiencing any treatment-emergent adverse event was summarized.
次要结局
- Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)(Week 24)
- Change From Baseline in CD4 Percentage at Week 24(Baseline; Week 24)
- Change From Baseline in CD4 Cell Count at Week 24(Baseline; Week 24)
- Change From Baseline in CD4 Cell Count at Week 48(Baseline; Week 48)
- Change From Baseline in CD4 Percentage at Week 48(Baseline; Week 48)
- Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)(Week 48)