CTRI/2009/091/000374已完成2 期
TMC114-TiDP29-C228: A Phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV in combination with low-dose ritonavir (DRV/rtv) in treatment-experienced HIV 1 infected children from 3 years to < 6 years of age. This trial will be referred to as ARIEL.
Tibotec Pharmaceuticals, EastGate Village, Eastgate, Little Island, CO Cork, Ireland0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
入选标准
- •1. Male or female children, aged between 3 years to less than 6 years at screening.
- •2. Subjects with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.).
- •3. Body weight from 10 kg to <20 kg at screening.
- •4. Subjects currently on stable ART for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of > 1000 copies/mL.
- •5. Screening genotype resistance test results showing < 3 DRV resistance-associated mutations (RAMs)10.
- •Note: DRV RAMs are: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V.
- •6. Parents or legal representative willing and able to give consent. Children will be informed about the trial as per description in PART II, Section 7.4.
- •7. Subjects can comply with the protocol requirements.
- •8. General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
排除标准
- •1. Subjects with presence of any currently active conditions included in the listing of WHO Clinical Stage 4 (see Addendum 5: Revised WHO Clinical Staging of HIV/AIDS for Infants and Children) and subjects with presence of a non-HIV encephalopathy.
- •2. Use of disallowed concomitant therapy.
- •3. Administration of any ARV or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available.
- •Note: DRV should not be used within 14 days following the use of tipranavir. A minimal 14 day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit (Day 1).
- •4. Life expectancy less than 6 months, according to the judgment of the investigator.
- •5. Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor.
- •6. Any active clinically significant disease (e.g., tuberculosis [TB], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator?s opinion, would compromise the subject?s safety or outcome of the trial.
- •7. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (DRV) or ritonavir.
- •Note: DRV is a sulphonamide-derivate. Subjects who previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and DRV has been identified in HIV 1 infected subjects participating in Phase II and Phase III trials (including the TMC114 C212 trial with HIV 1 infected subjects aged between 6 years and < 18 years).
- •8. Subjects with a laboratory abnormality greater than grade 2 as defined by age appropriate DAIDS grading scheme (grade 3 and 4 thrombocytopenia will be allowed).
研究者
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