PACTR202205715278722招募中1 期
Phase I study to determine Safety and Pharmacokinetics of subcutaneous administration of potent and broadly neutralizing anti-HIV-1 monoclonal antibodies (bNAbs), given to HIV-1 exposed uninfected (HEU) neonates and infants.
South African Medical Research Council0 个研究点目标入组 72 人开始时间: 2022年4月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
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
- 年龄范围
- 0 Day(s) 至 1 Month(s)（—）
- 性别
- Female
入选标准
- •Greater than or equal to 18 years of age
- •Documented HIV-1 infection
- •Breastfeeding at the time of consenting or willing to initiate breastfeeding in the immediate post partum period.
- •Able and willing to provide a signed informed consent form to participate in the study for herself and her infant.
- •Alive infant with a birth weight greater than or equal to 2.0 kg and lower than or equal to 4.0kg
- •Gestational age greater or equal to 36 weeks, assessed using birth Ballard Score (done up to 42 hours after birth)
- •Written consent of the one or both parents (according to South African regulation)
排除标准
- •Prior participation in any HIV-1 vaccine trial
- •Receipt of any other active or passive HIV immunotherapy or investigational product concurrently
- •Documented or suspected serious medical illness with fetal compromise or immediate life-threatening condition (other than HIV-infection as judged by the examining clinician)
- •Most recent CD4 count (within a time frame of =6 months) under 350 cells/mm3
- •Mother not on ART
- •Unable or not willing to breastfeed
- •Active tubercolosis
- •COVID-19 diagnosis in the past month
- •Plan to relocate in 1 year
- •Mother does not have her own cell phone
- •Mother not able to provide three alternate contact phone numbers
- •HIV-infected on birth PCR
- •Receipt of or anticipated need for blood product, immunoglobulin or immunosuppressive therapy. This includes infants who require hepatitis B immunoglobulins (HBIG) but not infants who receive hepatitis B vaccine in the new-born period
- •Documented or suspected serious medical or immediate life-threatening condition
- •Infant in ICU or high care requiring supplemental oxygen at time of first bNAb dose
- •Known allergy to study drug or components
- •Multiple birth, i.e. twins, triplets, quadruplets, etc
- •Baseline laboratory results:
- •Haemoglobin level less than 12.0 g/dL
- •Platelet count less than 100,000 cells/mm3
- •Absolute neutrophil count: for infants less than 24 hours old, less than 4,000 cells/mm3; for infants greater than 24 hours old, less than 1,250 cells/mm3
- •Serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT) greater than or equal to 1.25 times upper limit of age-adjusted normal.
- •Serum bilirubin at a level needing phototherapy
研究者
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