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临床试验/EUCTR2016-002345-39-Outside-EU/EEA
EUCTR2016-002345-39-Outside-EU/EEA进行中（未招募）1 期

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, andAntiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide(GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 InfectedAdolescents and Children

Gilead Sciences, Inc.0 个研究点开始时间: 2016年6月29日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
研究概览入排标准研究者记录与标识符相似试验

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.
  • •1) Age = 1 month to < 18 years (according to requirements of enrolling Cohort)
  • •2) Subject is 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) Body weight at screening for Cohort 1: = 35 kg (77 lbs); Cohort 2 = 25 kg (55 lbs); Cohort 3: = 14 to < 25 kg (= 31 to < 55 lbs); Cohort 4: Group 1: = 14 to < 25 kg (= 31 to < 55 lbs), Group 2: = 10 to < 14 kg (= 22 to < 31 lbs), Group 3: = 6 to < 10 kg (= 13 to < 22 lbs), Group 4: = 3 to < 6 kg (= 6.6 to < 13 lbs)
  • •5) Confirmed HIV infection if < 18 months of age (positive nucleic acid based test result to be provided)
  • •6) Adequate renal function: Estimated Glomerular Filtration Rate (eGFR) = 90 mL/min/1.73 m2 (= 1.5 mL/sec/1.73 m2) for children = 1 year of age using the Schwartz Formula.
  • •Adequate renal function: eGFR = the minimum normal values for children < 1 year of age using the Schwartz Formula.
  • •7) Adequate hematologic function defined as: a) Absolute neutrophil count > 500 cells/mm3 (> 0.50 GI/L), b) Hemoglobin > 8.5 g/dL (= 85 g/L), c) Platelets = 50,000/mm3 (= 50 GI/L)
  • •8) Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN)
  • •9) Total bilirubin = 1.5 mg/dL (= 26 µmol/L), or normal direct bilirubin
  • •10) Documented plasma 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) for = 6 months preceding the Screening visit for Cohorts 1, 2 and 3 and Cohort 4 Group 1. For Cohort 4, Groups 2-4: treatment naive or on ARV treatment for = 1 month. Antiretrovirals used for Prevention of Mother-to-Child Transmission (PMTCT) are allowed for naive or ART treated patients.
  • •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 tests.
  • •11) Stable antiretroviral regimen of 2 NRTIs in combination with a third agent for a minimum of 6 months prior to the screening visit. Subjects undergoing dose modifications to their antiretroviral regimen for growth or who are switching medication formulation(s) are considered to be on a stable antiretroviral regimen (Cohorts 1, 2, 3 and Cohort 4 Group 1).
  • •Stable ARV treatment of 2 NRTIs in combination with a third agent for a minimum of 1 month prior to the screening visit or treatment naive (Cohort 4 Groups 2, 3 and 4 only) (patient is considered treatment naive if ARVs were given for prevention of mother-to-child transmission only and not for HIV treatment)
  • •12) Plasma HIV-1 RNA < 50 copies/mL at the screening visit (Cohorts 1, 2, 3 and Cohort 4 Group 1). No threshold for HIV RNA levels for Cohort 4 Groups 2, 3 and 4.
  • •13) Life expectancy = 1 year
  • •14) Have no documented or suspected resistance to FTC, TFV, or INSTIs including, but not limited to, the reverse transcriptase resistance mutations K65R. Subjects with M184V/I AND HIV-1 RNA < 50 copies/mL may be enrolled in Cohort 4. Subjects in Cohort 4 with HIV-1 RNA > 50 copies/mL should

排除标准

  • •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
  • •1) Cohorts 1, 2, 3 and Cohort 4 Group 1: CD4+ cell count < 200 cells/ mm3. Cohort 4 Groups 2, 3 and 4: CD4+ cell count < 750 cells/mm3 for =1 to <12 months of age and < 500 cells/mm3 for =12 to <24 months of age.
  • •2) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
  • •3) An ongoing serious infection requiring systemic antibiotic therapy at the time of screening
  • •4) Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months
  • •5) Acute hepatitis in the 30 days prior to study entry
  • •6) Hepatitis B virus (HBV) surface antigen (HBsAg) positive
  • •7) Hepatitis C virus (HCV) antibody positive with detectable HCV RNA. Children < 18 months of age born to an HCV positive mother and/or HCV antibody positive will need to have 2 negative HCV RNA tests 6 months apart with the first test occurring no earlier than 2 months of age. In this situation, the earliest such a patient can be screened for study eligibility is at 8 months of age.
  • •8) 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 (e.g., diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to Day 1.
  • •9) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy)
  • •10) A history of or ongoing malignancy 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
  • •11) Females who are pregnant (as confirmed by positive serum pregnancy test)
  • •12) Females who are breastfeeding
  • •13) = 2 months of age and gestational age (GA) = 37 weeks (Cohort 4 Groups 2, 3 and 4)
  • •14) Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
  • •15) Have history of significant drug sensitivity or drug allergy
  • •16) Known hypersensitivity to the investigational medicinal product (IMP), the metabolites, or formulation excipients
  • •17) Participation in any other clinical trial, including observational studies without prior approval from sponsor is prohibited while participating in this trial
  • •18) Cohort 4 Groups 2, 3, and 4: Last dose of nevirapine (NVP) or efavirenz (EFV), if applicable, = 14 days prior to enrolment
  • •19) Subjects receiving ongoing therapy with any medication that is not to be taken with the study drug. Administration of any of the following medications must be discontinued at least 30 days prior to the Day 1 visit and for the duration of the study, with the exception of the subject’s prior ARV treatment regimen, which must be continued until their scheduled Day 1 visit.
  • •- Antiarrhythmic agent: dofetilide
  • •- Anticonvulsants: phenobarbital, phenytoin, carbamazepine, oxcarbazepine
  • •- Antimycobacterials: rifampin, rifapentine, rifabutin
  • •- Antiretrovirals: any antiretroviral drug that is

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