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临床试验/NCT03284645
NCT03284645已完成不适用

Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum

Obafemi Awolowo University4 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2017年12月22日最近更新:
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
194
试验地点
4
主要终点
Polymorphisms in antiretrovirals disposition genes

研究概览

简要总结

More than 150,000 babies became infected with HIV in 2015 alone. When HIV drugs are started before or early in pregnancy, HIV positive women can give birth to HIV negative baby. This is possible because HIV drugs can reduce the amount of the virus in the body to the extent that they become undetectable by the time of delivery and during the breastfeeding period. However, some women do not start taking these drugs on time because they become infected during pregnancy or lactation. This leads to detectable virus at the time of delivery and puts the baby at risk of becoming infected. Also, the amounts of HIV drugs in the body have to be at certain levels for them to work effectively. But findings from some research have recently showed that pregnancy increases the rate at which the body removes some HIV drugs used to prevent the transfer of HIV from mother to child. While this may not cause any problem in women with no detectable virus before pregnancy, it may affect the rate at which the HIV virus is removed from the body in those starting treatment late and may put the baby at risk. This project will investigate whether the changes in drug exposure caused by pregnancy or other factors have any effect on the rate at which the HIV virus is removed from the body. HIV positive pregnant women and those who recently delivered will be recruited from different hospitals and follow up will be until breastfeeding ends. The investigators will not be involved in treatment decisions and the primary care provider will be responsible for prescribing antiretroviral regimen based on current guidelines. Samples will be collected to measure levels of the virus and the drugs in three fluids that transfer the virus to the baby: blood, genital fluid, and breastmilk. The HIV status of the babies will be monitored until they stop breastfeeding.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ≥ 18 years old
  • Planned exclusive breastfeeding until 6 months of age
  • Able to understand study information and comply with follow-up schedule

排除标准

  • Severe maternal or infant illness
  • Planned exclusive formula feeding
  • Taking medication with known or uncertain interaction with study drugs

研究组 & 干预措施

ART Before or Early in Pregnancy

HIV positive pregnant women who started antiretroviral therapy (ART) before or early in pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Before or Early in Pregnancy

HIV positive pregnant women who started antiretroviral therapy (ART) before or early in pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Before or Early in Pregnancy

HIV positive pregnant women who started antiretroviral therapy (ART) before or early in pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily (Drug)

ART Started Third Trimester

HIV positive pregnant women starting antiretroviral therapy (ART) during the third trimester of pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Started Third Trimester

HIV positive pregnant women starting antiretroviral therapy (ART) during the third trimester of pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Started Third Trimester

HIV positive pregnant women starting antiretroviral therapy (ART) during the third trimester of pregnancy for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily (Drug)

ART Started Postpartum

HIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Started Postpartum

HIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg (Drug)

ART Started Postpartum

HIV positive women starting antiretroviral therapy (ART) after delivery for prevention of mother-to-child transmission of HIV and for their own health.

干预措施: Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily (Drug)

结局指标

主要结局

Polymorphisms in antiretrovirals disposition genes

时间窗: At study enrolment

Minimum plasma drug concentration (Cmin)

时间窗: At 2-3 months before delivery and at 10-12 weeks postpartum

Maximum plasma drug concentration (Cmax)

时间窗: At 2-3 months before delivery and at 10-12 weeks postpartum

Area under the concentration-time curve (AUC)

时间窗: At 2-3 months before delivery and at 10-12 weeks postpartum

HIV-1 viral load (RNA & DNA) in breastmilk

时间窗: From 6 weeks postpartum through study completion (1-2 monthly)

HIV-1 viral load (RNA & DNA) in CVF

时间窗: From week 28 to delivery (monthly)

Clearance over systemic availability (Cl/F)

时间窗: At 2-3 months before delivery and at 10-12 weeks postpartum

HIV-1 viral load (RNA & DNA) in plasma

时间窗: Through study completion (1-2 monthly)

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 (4)

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