A Pilot Study on the Efficacy of DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women Who Have Detectable Viral Load After 14 Weeks of Gestation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- undetectable HIV-1 plasma viral load at delivery
研究概览
简要总结
The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.
详细描述
Main endpoints:
Primary:
-Proportion of women with undetectable HIV-1 plasma viral load at delivery
Secondary:
- Proportion of women switching therapy up to delivery
- Frequency of adverse events, regardless its relationship to the ARV drugs, for mothers and babies Frequency of MTCT
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed HIV infection
- •No previous exposure to ARV drugs
- •Plasma viral load ≥1,000 copies/ml
- •Gestational age ≥ 14 and ≤ 28 weeks (checked by ultrasound)
- •Age ≥ 15 years
排除标准
- •Presence of genotypic resistance mutations for 3TC or DTG
- •Presence of active Hepatitis C
- •Hepatitis B infection (a positive test for HBcore or HBsurface antibodies)
- •Anemia (haemoglobin less than 8 g/dL);
- •Need to use concomitant drugs with potentially relevant DDI, which require DTG dose adjustment (e.g., rifampin, carbamazepine, phenobarbital,phenytoin)
- •Elevations in serum levels of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN) or ALT >3xULN and bilirubin >1.5ULN (with >35% direct bilirubin);
- •A history or clinical suspicion of unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hyperbilirubinaemia, oesophageal or gastric varices or persistent jaundice);
- •Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification
- •Presence of severe pre-eclampsia, or other pregnancy related events such as renal or liver abnormalities (grade 2 or above proteinuria, elevation in serum creatinine CrCl<50 ml/min), total bilirubin, ALT or AST)
研究组 & 干预措施
Lamivudine plus Dolutegravir in FDC
Single arm of 3TC+DTG for treatment of pregnant women with HIV infection
干预措施: Dolutegravir plus lamivudine in a FDC (Drug)
结局指标
主要结局
undetectable HIV-1 plasma viral load at delivery
时间窗: 6 months
proportion of women achieving a plasma HIV RNA viral load below 50 copies at delivery
次要结局
- switch fo therapy up to delivery(6 months)
- frequency of adverse events for mothers and babies(8 months)