EUCTR2020-001029-30-ES进行中（未招募）1 期
A multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance - SHIELD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Signed Written informed consent
- •- Ability to obtain an understood and signed written informed consent from parents/caregivers of the participant, and assent from the participant, when applicable.
- •Target Population:
- •- Male and female HIV-1 infected pediatric
- •participants from 6 years old and weighing at
- •least 20 kg to less than 18 years of age.
- •- Antiretroviral-experienced with documented
- •historical or baseline resistance to one or more
- •agents in at least two classes. All resistance has to be properly documented.
- •- Failing current antiretroviral regimen with a
- •confirmed plasma HIV-1 RNA = 1000 c/mL (first
- •value from Investigator within 6 months of
- •screening visit, with the second value obtained
- •from Screening labs, without a decline greater
- •than 1 log10, and no value <1000 in between).
- •- Documented resistance to at least one component of the current failing regimen per screening resistance testing.
- •- Must have at least 1 fully active and available
- •agent in 2 or more ARV classes, based on current and/or documented historical resistance testing, taking into account tolerability, and other safety concerns. At least two fully active agents must be a part of the initial OBT to be paired with FTR.
- •- Girls who have reached menarche must have a negative pregnancy test at screening, not be
- •breastfeeding, and be willing to adhere to
- •effective methods of contraception if sexually
- •active. All participants (male or female) have to
- •agree with recommendations in Section 8.7.1 for effective contraception.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Medical History and Concurrent Diseases:
- •- Unable to comply with dosing requirements (to
- •swallow solid pharmaceutical form of the
- •investigational medicinal product)
- •- Unable to comply with study visits
- •- Presence of a malabsorption syndrome or other
- •gastrointestinal dysfunction which might
- •interfere with drug absorption or render the
- •participant unable to take oral medication.
- •- Any clinical condition (including but not limited to recreational drug use) or prior therapy that, in
- •the opinion of the Investigator, would make the
- •participant unsuitable for the study
- •- Pregnancy and breastfeeding
- •Physical and Laboratory Test Findings:
- •- Chronic untreated Hepatitis B virus (HBV)
- •(however, participants with chronic treated HBV or spontaneously remitted HBV are eligible)
- •- HIV-2 infection
- •- Alanine aminotransferase (ALT) =5 times the
- •upper limit of normal (ULN), OR ALT =3xULN and bilirubin =1.5xULN (with>35% direct bilirubin)
- •- History of unstable liver disease, decompensated cirrhosis, or known biliary disorder
- •- History of congestive heart failure, or
- •congenital/acquired prolonged QT
- •syndrome/other cardiac diseases predisposing to prolonged QTc
- •- Hemoglobin < 8.0 g/dL
- •- Platelets < 50,000 cells/mm3
- •- Confirmed QTcF value > 450 msec, regardless of sex, at Screening or Day 1
- •- Current (defined as taking the medication within 14 days of Day 1) or anticipated treatment with medication considered prohibited or restricted as per Appendix II. Certain medication will be carefully evaluated as acceptable, see Appendix II.
- •- Participation in an experimental drug and/or
- •HIV-1 vaccine trial(s) within the previous 30 days
- •- Child in governmental care, e.g. child is a ward of the state. Note: This criterion does not apply if the child is officially adopted by a family/guardian.
研究者
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