Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months.
研究概览
简要总结
To evaluate the pharmacokinetics (PK) of LPV/r with saquinavir in HIV-1 infected children. To evaluate treatment response (clinical, immunological and virological) to LPV/r, SQV in Thai children.
详细描述
The PK and 24 week data has been published in Pediatric Infectious Diseases Journal. It showed that plasma drug concentrations of saquinavir, lopinavir and ritonavir were at the higher limits of expected ranges for adult treatment at approved dosages (1000/100 mg BID for saquinavir, 400/100 mg BID for lopinavir/r). The regimen was well tolerated and showed significant CD4 rise and VL decline at 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV-1 infection by HIV-DNA PCR if < 18 months old or by HIV ELISA if greater than or equal to 18 months old
- •Subject is less than or equal to 16 years of age at the day of the first dosing.
- •Subject is failing a current NRTI and/or NNRTI containing regimen and is naïve to protease inhibitor containing therapy.
- •Results of biochemistry and haematology testing should be within pre-specified ranges.
- •Subject is able to swallow capsules
- •Caretaker(s) is/are able and willing to sign the Informed Consent Form prior to screening evaluations.
排除标准
- •History of sensitivity/idiosyncrasy to lopinavir, ritonavir, saquinavir or chemically related compounds or excipients which may be employed in the trial.
- •Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
- •Inability of both child and caregiver(s) to understand the nature and extent of the trial and the procedures required.
- •Use of any of concomitant medication, including the drug listed below, that may interfere with the pharmacokinetics of LPV/r or SQV.
- •Rifampicin
- •Rifabutin
- •Phenobarbital
- •Phenytoine
- •Carbamazepine
- •Dexamethasone
- •Ketoconazole
- •Clarithromycin
研究组 & 干预措施
double-boosted PI
double-boosted protease inhibitor combination
干预措施: Lopinavir/r plus saquinavir (Drug)
结局指标
主要结局
Intensive 0-12h PK sampling for plasma levels of LPV and SQV, and blood sampling. CD4 viral load safety lab every 3 months.
时间窗: 96 week
次要结局
未报告次要终点