EUCTR2013-001969-16-IT进行中（未招募）1 期
A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •Antiretroviral treatment-experienced, HIV-1 infected male and
- •female subjects 4 weeks (gestational age of at least 44 weeks)
- •to < 18 years of age
- •Body weight at screening as follows:
- •o Cohort 2 – greater than 15 kg
- •o Cohort 3 – greater than 10.6 kg
- •o Cohort 4 – greater than 5 kg
- •Part A: Evidence of suppressed viremia or failing a current
- •antiretroviral regimen as defined below.
- •Part B: Evidence of failing a current antiretroviral regimen as
- •defined below.
- •Criteria for subjects with evidence of suppressed viremia (Part A
- •Plasma HIV-1 RNA concentration (at least 2 consecutive
- •measurements) at an undetectable level according to the assay
- •being used for at least 3 months prior to screening, and HIV-1
- •RNA <50 copies/mL (Roche COBAS TaqMan v2.0) at
- •Stable antiretroviral regimen including one of the following
- •PI/r for at least 3 months prior to screening: lopinavir/r
- •(Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or
- •fosamprenavir/r. Subjects undergoing dose modifications to
- •their antiretroviral regimen for growth or switching medication
- •formulations are considered to be on a stable antiretroviral
- •Criteria for subjects failing a current antiretroviral regimen
- •(Parts A and B):
- •HIV-1 RNA >1,000 copies/mL at screening
- •(Roche COBAS TaqMan v2.0)
- •Prior treatment for HIV-1 infection, defined as 6 months of
- •antiretroviral treatment experience (with the exception of
- •Cohort 4 where less than 6 months of treatment experience is
- •acceptable) and at least 1 documented resistance mutation as
- •defined by current IAS-USA Guidelines. These resistance
- •mutations must be documented in a historical genotype
- •report(s), or in the genotype report at screening provided by
- •Gilead Sciences.
- •Stable antiretroviral regimen (or no antiretroviral regimen) for
- •at least 30 days prior to screening. Subjects undergoing dose
- •modifications to their antiretroviral regimen for growth or
- •switching medication formulations are considered to be on a
- •stable antiretroviral regimen.
- •Screening genotype must show full sensitivity to EVG.
- •Ability to construct a BR that must contain one of the
- •following fully active PI/r: lopinavir/r (Kaletra), atazanavir/r,
- •darunavir/r, tipranavir/r, or fosamprenavir/r. (Fully active is
- •defined by genotypic analysis.)
- •Genotypic sensitivity score (GSS) of at least 2 (including the
- •fully active PI/r and EVG).
- •Adequate renal, hematologic, and hepatic function.
- •No opportunistic infection within 30 days of study entry.
- •Are the trial subjects under 18? yes
- 另有 5 项未显示
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •Subjects with the following CD4+ cell counts:
- •— For Cohorts 1 and 2: Screening CD4+ cell count
- •< 50 cells/mm3
- •— For Cohort 3: Screening CD4+ cell count < 75 cells/mm3
- •— For Cohort 4: Screening CD4+ cell count < 200 cells/mm3
- •Evidence of active pulmonary or extra-pulmonary tuberculosis
- •— Within 3 months of the Screening visit for all subjects
- •6 months of age or older
- •— At any time for subjects younger than 6 months
- •An ongoing serious infection requiring systemic antibiotic
- •therapy at the time of screening
- •An acquired immunodeficiency syndrome (AIDS)-defining
- •condition with onset within 30 days prior to screening
- •Life expectancy of < 1 year
- •For subjects with HIV-1 RNA >1,000 copies/mL at screening,
- •prior treatment of any duration with an integrase strand transfer
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