Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Safety and tolerability in pregnant women
研究概览
简要总结
Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of transmission of HIV. Pregnant women and mothers who have recently given birth often maintain sexual activity, and research has shown that they may be at greater risk of HIV infection during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir 1% gel in healthy, pregnant women and healthy, breastfeeding women.
详细描述
Microbicides are substances, like gels or foams, being developed that can be applied before intercourse to prevent transmission of HIV. Research has shown that pregnant women are still at risk of sexual transmission of HIV, and some research has suggested that pregnant women may be at increased risk of HIV infection. Microbicides may also aid in preventing mother-to-child transmission of HIV, because they might be a feasible alternative to oral or intravenous medications in regions where these methods are difficult to implement. In tests on healthy women the vaginal microbicide tenofovir 1% gel has been safe and well tolerated. This study will test the safety of tenofovir 1% gel in healthy, pregnant women and healthy, lactating women.
Participation in this study will last approximately 3 to 10 weeks. Pregnant women will be followed until approximately 2 weeks after delivery of their children, and lactating women will be followed for 3 weeks. Pregnant women will be given either the tenofovir 1% gel or a placebo gel to be applied daily for 7 days. Groups of pregnant women will be further divided according to how late into pregnancy they enroll.
Pregnant women will have study visits at enrollment, 6 days after enrollment, and at delivery. They will also participate in phone assessments 1, 3, and 14 days after enrollment and at delivery.
Lactating women will be given tenofovir 1% gel and have study visits at enrollment and 6 days after enrollment. They will also participate in phone assessments 1, 3, and 14 days after enrollment.
All participants will complete blood tests, physical exams, and assessments of adverse events.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pregnancy cohort, placebo
Pregnant women will receive placebo gel.
干预措施: Placebo gel (Other)
Lactation cohort, tenofovir gel
Lactating mothers will receive tenofovir gel.
干预措施: Tenofovir 1% gel (Drug)
Pregnancy cohort, tenofovir gel
Pregnant women will receive tenofovir gel.
干预措施: Tenofovir 1% gel (Drug)
结局指标
主要结局
Safety and tolerability in pregnant women
时间窗: Measured at 2 weeks post-delivery
Safety and tolerability in pregnant women are assessed by number of specific Grade 2 or greater adverse events in laboratory abnormalities, genital/pelvic signs/symptoms, or pregnancy complications
Safety and tolerability in infants, defined as no intensive care admission greater than 24 hours and no sepsis
时间窗: Measured at 2 weeks post-delivery
Safety and tolerability in lactating women, defined as specific Grade 2 or greater adverse events in laboratory abnormalities or genital/pelvic signs/symptoms
时间窗: Measured at Day 14
Safety and tolerability in lactating women are assessed by number of specific Grade 2 or greater adverse events in laboratory abnormalities or genital/pelvic signs/symptoms
Safety and tolerability in infants of lactating mothers
时间窗: Measured at Day 14
Safety and tolerability in infants of lactating mothers is defined as no inpatient admission (confirmed on review of medical records) with diagnosis of adverse event (AE) judged to be related to study product
Tenofovir levels in maternal blood or breast milk
时间窗: Measured at Day 6 or delivery, depending on cohort
次要结局
- Presence of tenofovir in blood among infants of participants in the pregnancy and lactation cohorts(Measured at Day 6 or delivery, depending on cohort)
- Impact of tenofovir gel exposure on the presence of select organisms associated with neonatal sepsis among participants in the pregnancy cohort, (e.g., Group B β-hemolytic streptococcus, Escherichia coli)(Measured at Day 6)
- Adherence to daily use of tenofovir 1% gel for 7 days and its acceptability among pregnant and lactating women(Measured at Day 6)