A Phase I/II, Open-Label Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Infected Pregnant Women and Their Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 20
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants.
Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.
详细描述
New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Phase I perinatal trial.
Two cohorts of women and infants are enrolled in this study. The first five mother/infant pairs enrolled comprise Group I. Mothers enrolled in this group must allow their infants to receive ZDV. Eight mother/infant pairs are then enrolled in Group II; Group II infants are allocated into two groups: those whose mothers allow the administration of ZDV (Group IIA) and those whose mothers do not (Group IIB).
Group I:
Women:
Beginning at a minimum of 14 weeks gestation:
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women may be eligible for this study if they:
- •Are HIV-positive.
- •Are at least 13 years old (need consent of parent or guardian if under 18).
- •Are unable to or refuse to take ZDV or the woman's doctor says that she should take d4T.
- •Are 14 to 34 weeks pregnant.
排除标准
- •Women will not be eligible for this study if they:
- •Have a history of peripheral neuropathy.
- •Have an active opportunistic infection and/or serious bacterial infection within 14 days of study entry.
- •Have severe diarrhea.
- •Are allergic to d4T or 3TC.
- •Use illicit drugs or abuse alcohol.
- •Are taking anti-HIV drugs other than study medications.
- •Are planning to breast-feed.
- •Are having a problem pregnancy (baby is not developing correctly or will not survive birth) or have had pregnancy complications in the past.
- •Babies will not be eligible for this study if they:
- •Are unable to take medications by mouth for more than 72 hours.
- •Have severe birth defects or other life-threatening conditions.
- •Are underweight (less than 2 kg).