PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 11
- 主要终点
- Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
研究概览
简要总结
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months
The secondary objectives of PENTA15 were:
To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir
To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24 months and ≥24 to <36 months)
To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
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
- 3 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and children with confirmed presence of HIV-1 infection
- •Infants and children aged 3 to <36 months
- •Parents/guardians able and willing to give written, informed consent
- •Currently on combination ART including Abacavir (ABC) oral solution with or without Lamivudine (3TC) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks.
- •HIV-1 RNA viral load either;
- •suppressed HIV-1 RNA viral load (i.e. <400 copies/ml)
- •non-suppressed, but low, HIV-1 RNA viral load (i.e. 400-20 000 copies/ml). The non-suppressed children should have had a stable or decreasing HIV-1 RNA viral load prior to study entry and should be considered to be still gaining benefit from the current regimen
- •Stable or rising CD4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks.
排除标准
- •Intercurrent illness
- •Receiving concomitant therapy except prophylactic antibiotics
- •Abnormal renal or liver function (grade 3 or above)
结局指标
主要结局
Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing
时间窗: Week 0
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
Cmax of Abacavir on Twice Daily Dosing
时间窗: Week 0
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.
AUC(0-24) of Abacavir on Once Daily Dosing
时间窗: Week 4
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication
Cmax of Abacavir on Once Daily Dosing
时间窗: Week 4
Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.
次要结局
未报告次要终点