PACTR202308483453792尚未招募2 期
Phase II double blind randomised placebo-controlled clinical trial to evaluate the safety & pharmacokinetics ofVRC07-523LS in breastfed HIV-exposed uninfected and HIV-infected neonates and infants in South-Africa
South African Medical ResearchCouncil0 个研究点目标入组 129 人开始时间: 2022年11月11日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 129
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 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Eligibility criteria
- •Maternal inclusion criteria
- •1) Documented HIV-1infection antenatally or at delivery and receiving ART as per national guidelines
- •2) Greater than or equal to18 years of age
- •3) Breastfeeding at the time of enrolment or willing to initiate breastfeeding in the immediate post-partum period
- •INFANT ELIGIBILITY CRITERIA
- •1) Gestational age greater or equal to36 weeks, assessed using dual methods of early sonar AND birth Ballard Score (done up to 42 hours after birth)
- •2) Birth weight greater than or equal to 2.0 kg and lower than or equal to 4.5kg
- •3) Written consent of one or both parents (according to South African regulation)
排除标准
- •Mother exclusion criteria
- •1) Prior participation in anyHIV-1 vaccine trial
- •2) Receipt of another active or passive HIVimmunotherapy or investigational product concurrently
- •3) Documented or suspected serious medical illness with fatal compromise or immediate life-threatening condition (other than HIV-infection as judged by the examining clinician)
- •4) Unable or unwilling to provide a signed informed consent to participate to the study for herself and her infant
- •5) Known active tuberculosis or other opportunistic infection
- •6.Plan to relocate in 1 year or do not have a local address
- •7)Does not have her own cell phone
- •8)Not able to provide three alternate contact phone numbers
- •9) Multiple pregnancies, i.e. twins, triplets, quadruplets, etc.
- •10) Unwilling or unable to comply with the schedule of activity
- •Infant exclusion criteria
- •1) Receipt of or anticipated need for blood product, immunoglobulin, or immunosuppressive therapy. This includes infants who require hepatitis immunoglobulins (HBIG) but not infants who receive hepatitis Bvaccine in the new-born period
- •2)Documented or suspected serious medical or immediate life-threatening condition
- •3) Infant in ICU or high care requiring supplemental oxygen at time of bNAb dose
- •4) Known allergy to study drug or components
- •5) Baseline laboratory results on all neonates
- •-Hemoglobin level less than 12.0 g/dL- Platelet count less than 100,000cells/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 than1,250 cells/mm3
- •- Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase ALT) greater than or equal to 1.25 times the upper limit of age-adjusted normal
- •Infant: 0 Month-23Month
- •12 Month(s)
研究者
相似试验
已完成
不适用
The effect of vitamin supplementation, genotype and homocysteine on migraine frequency and severity in females diagnosed with migraine with aura.Alternative and Complementary Medicine - Other alternative and complementary medicineNeurological - Other neurological disordersMigraine with auraACTRN12609000275268Griffith University250
进行中（未招募）
1 期
A randomised phase II double blind placebo controlled trial of Whole Brain Radiotherapy (WBRT) and Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) with multiple brain metastases - TACTICEUCTR2006-000113-38-GBniversity College London144
已完成
2 期
Phase II study of KRP-N118 in patients with Nocturia due to nocturnal polyuriaocturia due to nocturnal polyuria.JPRN-jRCT2080224041Kyorin Pharmaceutical Co.,LTD880
已完成
不适用
Phase II randomised, double-blind, placebo controlled, multicentre study of orally administered ATL-104 (by swallowable mouthwash) to assess safety and tolerance and effect on oral mucositis in patients with haematological malignancies after treatment with chemotherapy associated with peripheral blood stem cell transplant (PBSCT)ISRCTN68967559Alizyme (UK)60
已完成
不适用
Phase II double-blind, randomised, placebo-controlled study the safety and immunogenicity of H1/IC31 (trademarked), in HIV-infected adults without TBHIV/AIDSTuberculosisPACTR201105000289276Statens Serum Institut48