ISRCTN10901519进行中（未招募）4 期
Evaluating efficacy and safety of switching a boosted protease inhibitor to fostemsavir in PLWH with limited therapeutic options
EAT ID0 个研究点目标入组 60 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •1. HIV-1 infected adults
- •2. Non-pregnant Individuals of Childbearing potential (IOCBP) must be confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a negative urine hCG test at Day 1 and each visit).
- •3. IOCBP should be receiving highly effective contraception.
- •4. On stable & suppressive cART with a VL <50 c/mL for 1 year allows one blip (50-200 c/mL) as long as resuppressed below 50 for 6 consecutive months prior to enrolment and with no major adherence issues.
- •5. Patients on bPI with no other potential switch to another approved regimen (except to Ibilizimuab if available) and are willing to switch to Fostemsavir from their boosted PI.
- •6. No significant laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators.
- •7. Willing to sign an informed consent and take part in the trial.
排除标准
- •1. Age < 18 years.
- •2. Unable to take part in the trial according to the investigator opinion (example: unable to understand the trial information leaflet, unable to provide written consent, etc.)
- •3. History of being on a cART containing Fostemsavir.
- •4. HIV-1 subtype AE
- •5. Use of medications that are known to interact with Fostemsavir. Contraindications are given in appendix 3, and full information on drug-drug interactions is given in SmPC.
- •6. Hypersensitivity to active substance or excipient of Fostemsavir as listed in SmPC.
- •7. Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical or anal intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Trial medical monitor for inclusion of the patient prior to trial entry.
- •8. Known acute or chronic viral hepatitis including, but not limited to, A, B, or C. Chronic hepatitis B and history of hepatitis C (cured) are allowed.
- •9. Any investigational drug within 30 days prior to the trial drug administration
- •10. IOCBP who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the trial
- •11. Patients with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- •12. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophagael or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •13. History of congestive heart failure or congenital prolonged QT syndrome.
- •14. Confirmed QT value > 500 msec at Screening or Day 1.
- •15. Confirmed QTcF value > 470 msec for women and > 450 msec for men at Screening or Day 1
- •16. ALT>5 times the ULN, OR ALT>3xULN and bilirubin>1.5xULN (with >35% direct bilirubin).
- •17. Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
研究者
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