The Effect of Single Dose Carbamazepine on the Pharmacokinetics of Single Dose Nevirapine (Viramune, NVP) and Development of NVP Resistance, PMTCT Program of Moshi, Tanzania (VITA1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Cord blood will be taken less than 30 minutes after delivery
研究概览
简要总结
Primary
- pharmacokinetics of single dose nevirapine
- the effect of single dose carbamazepine on the pk of single dose nevirapine
- resistance against nevirapine before and after.
- follow-up on HIV status newborns
- relation between nevirapine levels in cord blood and plasma
Secondary
* safety of single dose nevirapine and nevirapine/carbamazepine
Hypothesis:
Single dose carbamazepine decreases development of resistance to nevirapine in HIV positive pregnant Tanzanian women by decreasing nevirapine half-life.
详细描述
Without the use of preventative measures, the risk of mother-to-child transmission (MTCT) of HIV-1 is estimated to vary between 25 and 48%. The regimen of single dose of nevirapine to the mother just before delivery and a single dose of nevirapine to the newborn within 24 - 72 hours after birth reduces the risk of MTCT by 50%, is affordable in many situations and is therefore standard of care in many African countries, like Tanzania. Recent studies, however, have shown that this single dose to the mother can induce the occurrence of nevirapine resistance in a large number of mothers. The mechanism of occurrence of nevirapine resistance already after a single dose is most likely related to the long elimination half-life of the drug. The subtherapeutic plasma levels present the perfect environment for the occurrence of resistance as the concentrations are subinhibitory for several days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infected
- •antiretroviral naive
- •not intending to relocate out of area during study
- •willing to adhere to follow up scheme
- •ability and willing to give written consent
- •pregnant between 18 and 40 years
- •willing and able to regularly attend the Antenatal clinic
排除标准
- •serious illness that requires systemic treatment or hospitalization
- •any condition that would compromise subject's ability to participate
- •previously treated for HIV with antiretroviral agents, including single dose nevirapine used for MTCT
- •inability to understand the nature and extent of the trial and procedures
研究组 & 干预措施
Carbamazepine
An oral dose of 400mg Carbamazepine is added to the 200mg oral dose Nevirapine intake prior delivery
干预措施: carbamazepine and nevirapine (Drug)
Nevirapine
Standard therapy of 200mg Nevirapine oral prior to delivery
干预措施: Nevirapine (Drug)
结局指标
主要结局
Cord blood will be taken less than 30 minutes after delivery
时间窗: 0 - 30 min after delivery
Blood samples from mother will be taken less than 30 minutes after delivery to measure viral load and CD4 count.
时间窗: 0 - 30 min after delivery
Blood samples will be drawn from mother and child at week 1 (day 6-8), week 2 (day 13-15) and week 3 (day 20-22)
时间窗: day 6 - 22 after delivery
From all samples plasma nevirapine and if applicable carbamazepine levels will be determined in women and newborns.
时间窗: 0 30 min after delivery - week 3 after delivery
次要结局
未报告次要终点