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临床试验/NCT00872872
NCT00872872已完成不适用

Nevirapine Plasma Level After Discontinuation of Short-term Antiretroviral Treatment for the Prevention of Mother-to-child Transmission of HIV and Development of Drug Resistant HIV-1 Variants With 1 or 2 Weeks Continuation of Zidovudine/Lamivudine in Women After Delivery

Thai Red Cross AIDS Research Centre1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation

研究概览

简要总结

Three-drug combination of antiretroviral regimens has been used increasingly in HIV-infected pregnant women worldwide, both for the prevention of mother to child transmission of HIV (PMTCT) and for women's own health. Use of these drugs in pregnant women solely for PMTCT means that these drugs will need to be discontinued in the majority of women after delivery.

Certain antiretroviral regimens contain drugs with long half-life (drugs that stay in the body for a longer period of time after discontinuation than other drugs in the same regimen), such as nevirapine (NVP). HIV can easily develop resistance to NVP when NVP is the only drug left in the body (similar to monotherapy). Given two other drugs for up to 1 week after discontinue NVP (to mimic three-drug regimen while waiting for NVP elimination) can help reduce, but not eliminate, the development of resistant virus.

Unfortunately, NVP-containing regimens are the most widely used regimens for pregnant women in developing countries due to its low cost and its availability in fixed-dose combinations. These study will explore how fast NVP is eliminated from women after delivery and to see if given zidovudine/lamivudine (AZT/3TC) for 1 or 2 weeks after NVP discontinuation can help reduce the development of NVP resistant virus.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing and able to provide 2 separated written informed consents to take part in the Thai Red Cross PMTCT program and in the study
  • Female and aged between 18-45 years
  • Documented HIV-1 infection
  • Pregnant for a maximum of 36 weeks at the first dose of study medication
  • Baseline CD4 cell count >250 cells/mm3
  • Intend to discontinue ART after delivery

排除标准

  • History of significant reaction or allergy to the drugs that may be used in the study
  • Antiretroviral (ARV)-experienced including previous ARV use for the prevention of mother-to-child transmission of HIV
  • Documented NVP- or 3TC-resistant HIV-1 strains
  • Concomitant use of medications that interfere with NVP plasma level
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) >1.25 times the upper limit of normal
  • Inability to understand the nature and extent of the trial procedures required
  • Pregnant woman, in the opinion of the investigator, should not participate in the study

研究组 & 干预措施

AZT/3TC 1 week after delivery

Active Comparator

AZT/3TC 1week after delivery

干预措施: AZT/3TC 2 weeks after delivery (Drug)

AZT/3TC 2 weeks after delivery

Experimental

AZT/3TC 2 weeks after delivery

干预措施: AZT/3TC 2 weeks after delivery (Drug)

结局指标

主要结局

Proportion of patients with detectable NVP plasma level at week 1, 2, 3 and 4 after NVP discontinuation

时间窗: Week 1, 2, 3 and 4 after NVP discontinuation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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