EUCTR2013-001402-28-GB进行中（未招募）1 期
A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered with a Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, VirologicallySuppressed Pediatric Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •1) Age 3 to < 18 years (according to requirements of enrolling Cohort)
- •2) Participants able to provide written assent if they have the ability to
- •read and write (if applicable per their local institutional guidelines and
- •local country regulations)
- •3) Parent or legal guardian able to provide written informed consent prior to any screening evaluations, and willing to comply with study
- •requirements
- •4) A negative serum -HCG pregnancy test is required for female subjects of childbearing potential only
- •5) Body weight at screening is as follows:
- •Cohort 1: 12 years to <18 years, = 25 kg
- •Cohort 2: 6 years to <12 years, = 25 kg to < 35 kg
- •Cohort 3: = 3 years, = 14 kg to < 25 kg
- •6) Adequate renal function: Estimated Glomerular Filtration Rate (eGFR)
- •= 90 mL/min/1.73 m2 using the Schwartz Formula:
- •Schwartz Formula (mL/min/1.73 m2) = k x L/SCr (k is a proportionality
- •constant, L is height in centimeters (cm) and SCr is serum creatinine
- •(mg/dL). The value of k is 0.55 for children (= 2 to < 12 years old) and
- •adolescent girls (= 12 years old) and 0.70 for adolescent boys (= 12
- •years old).
- •7) Male and female subjects of childbearing potential, or who reach
- •childbearing potential during study participation, must agree to utilize
- •highly effective contraception methods while on study treatment or
- •agree to abstain from heterosexual intercourse throughout the study
- •period. Pre-pubertal females (Tanner stages 1 and 2) are not considered
- •to be of childbearing potential, unless onset of menarche has occurred.
- •8) Adequate hematologic function defined as:
- •a) Absolute neutrophil count = 500 cells/mm3 (Subjects with neutrophil
- •count of < 500/mm3 documented at least twice within 6 months of
- •screening, and whom, according to the investigator, have no evidence of
- •immunosuppression associated with low neutrophil count, can enroll in
- •the study contingent upon approval from the Gilead study Medical
- •b) Hemoglobin > 8.5 g/dL
- •c) Platelets = 50,000/mm3
- •9) Adequate hepatic function defined as:
- •a) Transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
- •b) Total bilirubin = 1.5 mg/dL or a normal direct bilirubin
- •10) Stable antiretroviral regimen for a minimum of 3 months prior to the
- •screening visit.
- •11) Documented plasma HIV-1 RNA for = 3 months preceding the
- •Screening visit
- •Participants enrolled after the implementation of Amendment 8:
- •Virologically suppressed = 3 months preceding the Screening visit: HIV-
- •1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA
- •level according to the local assay being used if the limit of detection is =
- •50 copies/mL)
- •Viremic: HIV-1 RNA = 50 copies/mL and on a stable regimen
- •For virologically suppressed subjects, unconfirmed virologic elevations
- •of = 50 copies/mL (transient detectable viremia, or blip) prior to
- •screening are acceptable. If the lower limit of detection of the local HIV-
- •1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1
- •RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA
- 另有 7 项未显示
排除标准
- •1) Screening CD4 cell count < 200 cells/mm3
- •2) An acquired immunodeficiency syndrome (AIDS)-defining condition
- •with onset within 30 days prior to screening
- •3) Life expectancy of < 1 year
- •4) An ongoing serious infection requiring systemic antibiotic therapy at
- •the time of screening
- •5) Evidence of active pulmonary or extra-pulmonary tuberculosis (TB)
- •disease, within 3 months of the Screening visit
- •6) Anticipated requirement for rifamycin treatment while participating in
- •the study Note: prophylactic isoniazid therapy for latent TB is allowed
- •7) Active HCV infection. Subjects with positive HCV antibody, and
- •without detectable HCV RNA are permitted to enroll
- •8) Positive Hepatitis B (HBV) surface antigen or other evidence of active
- •HBV infection. Note: Subjects with positive HBV surface antibody, and no
- •evidence of active HBV infection are permitted to enroll
- •9) Subjects with clinically significant abnormal ECGs
- •10) Have any serious or active medical or psychiatric illness, which in
- •the opinion of the Investigator, would interfere with subject treatment,
- •assessment, or compliance with the protocol. This would include
- •uncontrolled renal, cardiac, hematological, hepatic, pulmonary (including
- •chronic asthma), endocrine (including diabetes), central nervous,
- •gastrointestinal (including ulcers), vascular, metabolic (including thyroid
- •disorders and adrenal disease), immunodeficiency disorders, active
- •infection, or malignancies that are clinically significant or require
- •treatment within 30 days prior to Day 1
- •11) Subjects experiencing decompensated cirrhosis (eg, ascites,
- •encephalopathy, etc.)
- •12) A history of, or ongoing, malignancies other than cutaneous Kaposi's
- •sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous
- •squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are
- •eligible, but must not have received any systemic therapy for KS within
- •30 days of Day 1, and are not anticipated to require systemic therapy
- •during the study
- •13) Pregnant or lactating subjects
- •14) Current alcohol or substance abuse judged by the Investigator to
- •potentially interfere with subject compliance
- •15) A History of significant drug sensitivity or drug allergy
- •16) Known hypersensitivity to the investigational medicinal product
- •(IMP), its metabolites, or formulation excipient
- •17) Have previously participated in a clinical trial involving
- •administration of any investigational agent within 30 days prior to Day 1
- •18) Participation in any other clinical trial, including observational
- •studies, without prior approval from sponsor is prohibited while
- •participating in this trial
- •19) Participants receiving ongoing therapy with any medication that is
- •not to be taken with COBI, F/TAF, a component of the current
- •antiretroviral regimen, or drugs not to be used with ritonavir (refer to
- •prescribing information for drugs used as part of the antiretroviral
- •regimen). Administration of any of the following medications (Table 4-1)
- •must be discontinued for:
- 另有 11 项未显示
研究者
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