ISRCTN71468401已完成不适用
Impact of highly active anti-retroviral therapy (HAART) during pregnancy and breastfeeding on mother-to-child transmission (MTCT) and mother's health
World Health Organization (WHO) (Switzerland)0 个研究点目标入组 2,400 人开始时间: 2004年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pregnant, with a gestational age of 28 - 34 weeks (or between 16 and 32 weeks gestation if the woman is referred with medically-documented HIV stage four [clinical AIDS] or CD4+ cell count below 200 cells/mm^3 diagnosed before study screening)
- •2. No evidence of clinically-significant conditions likely to require specific care arrangements and which may interfere with study interventions (obstetric, cardiac, respiratory [including active tuberculosis], hepatic, gastrointestinal, endocrine, renal, haematologic, psychiatric, neurologic, or allergic) as assessed by the study site Principal Investigator
- •3. Confirmation of HIV infection at the study site
- •4. Not having received an HIV vaccine (never enrolled in an HIV-vaccine trial)
- •5. Willingness to receive, and no contraindication to receive, the short MTCT-prophylaxis regimen as a minimum
- •6. No previous enrolment in the Kesho Bora study
- •7. Capacity and willingness to participate in all follow-up visits, including participating in all clinical examinations, having blood drawn, as well as willingness for their infant to be clinically and physically examined and have blood drawn
- •8. Residing, and planning to continue to reside, within a predefined, site-specific catchment area until two years after delivery
- •9. Ability and willingness to give informed consent for enrolment in the study
- •10. Not currently taking Anti-RetroViral drugs (ARV) drugs
- •Women who meet the above eligibility criteria will be invited to enrol in the study (Part I). Those who, in addition, meet WHO criteria for initiating HAART, have no contraindications to HAART and accept HAART will be enrolled in Part IA and will receive HAART. All other women will be enrolled in Part IB and will receive the short-course MTCT prophylaxis. This includes women not meeting WHO criteria for treatment, having a contraindication to HAART, or refusing HAART. Additional eligibility criteria for women in Part IB to be enrolled in the randomised controlled trial (Part II) are:
- •1. Not meeting WHO clinical criteria for treatment
- •2. Having CD4+ cell count between 200 and 500 cells/mm^3
- •3. Having no contraindication to the triple-ARV MTCT-prophylaxis regimen
- •4. Willing to be randomised to receive the triple-ARV or short-course MTCT-prophylaxis regimen
排除标准
- •Does not comply with the inclusion criteria above.
研究者
相似试验
已完成
不适用
Highly Active Antiretroviral Treatment (HAART) of Human Immunodeficiency Virus (HIV)-infection in a town in Cameroon: randomised controlled study to suggest which treatment starting point is most beneficial for the patientsHIV infectionInfections and InfestationsHIVISRCTN22114173Institute of Community Medicine, University of Tromsø (Norway)100
已完成
不适用
Highly Active Antiretroviral Therapy and Cardiovascular Risk factor profiles of HIV-infected Subjects in Nigeria: a cross-sectional studyHypertensionJPRN-UMIN000027983niversity of Warwick Benue State University Teaching Hospital400
进行中（未招募）
1 期
Impact of extremely early antiretroviral therapy to reduce VIral REservoir and induce functional CURE of HIV-1 infection. A pilot comparative study.HIV-1 infectionEUCTR2015-000251-24-ESFundacio Privada Clinic per a la Recerca Biomedica15
已完成
不适用
Impact of HIV and Its Treatment on Reverse Cholesterol TransportHIV InfectionsNCT00168233The Alfred44
已完成
不适用
A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive PatientsHIV InfectionsNCT00000890National Institute of Allergy and Infectious Diseases (NIAID)200