Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- frequency of NNRTI resistance development
研究概览
简要总结
The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection than sd nevirapine but with less NNRTI resistance development.
详细描述
Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.
排除标准
- •CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
- •Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L
研究组 & 干预措施
1
AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
干预措施: Zidovudine and Lamivudine (Combivir) (Drug)
2
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
干预措施: Emtricitabine and Tenofovir (Truvada) (Drug)
结局指标
主要结局
frequency of NNRTI resistance development
时间窗: 6 weeks post partum
frequency of mother-to-child HIV transmission
时间窗: 6 weeks post partum
次要结局
- Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia(Delivery, day 7, day 42 and month 9 post partum)
- Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D(Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child)