ISRCTN11193709已完成2 期
A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.
PENTA Foundation0 个研究点目标入组 318 人开始时间: 2015年3月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 318
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37304494/ (added 12/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. HIV-1 infected children weighing = 17 kg at the screening visit
- •2. Aged 6 to < 18 years old
- •3. Parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol
- •4. Children must have all HIV-1 RNA viral load <50c/mL for at least 12 months with a minimum of two separate results before screening.
- •5. Children on a 3-drug PI/r or NNRTI containing regimen for at least 6 months.
- •6. Children/parents/guardians prepared to switch if randomised to elvitegravir + darunavir/ritonavir arm
- •7. Children and parents prepared to restart the current ART regimen after simplification if viral load restart criteria are met (see Section 5.5)
- •8. For children aged 6-12 either:
- •8.1. Children and caregivers are willing to participate in the lead-in PK study if the child is aged 6-12 and the PK study is still enrolling children in their weight band* OR
- •8.2. Data from the lead-in PK study have been analysed and children aged 6-12 can be enrolled directly into the main study
- •* only children randomised to Arm 1 will take part
排除标准
- •1. Receiving or requiring agents with interactions with darunavir, RTV, or EVG
- •2. Evidence of resistance to DRV or integrase inhibitors (for participants in clinical sites where resistance testing is standard of care)
- •3. Previous exposure to integrase inhibitors for more than 2 weeks
- •4. History of previous encephalopathy
- •5. Intercurrent illness (randomisation can take place after the illness resolves)
- •6. Creatinine, AST or ALT of grade 3 or above at screening.
- •7. Diagnosis of tuberculosis and on anti-tuberculosis treatment (children can be enrolled after successful tuberculosis treatment)
- •8. Hepatitis B or Hepatitis C co-infection
- •9. Pregnancy or risk of pregnancy in girls of child-bearing potential unless committed to taking effective contraception
研究者
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