PACTR202007806554538招募中1 期
Open label, single arm, two-stage trial to evaluate the single and multi-dose pharmacokinetics and safety of the abacavir/lamivudine/lopinavir/ritonavir (30/15/40/10mg) (4-in-1) fixed-dose granule formulation in HIV-exposed neonates
Stellenbosch University Tygerberg Hospital0 个研究点目标入组 50 人开始时间: 2020年6月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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
- All
入选标准
- •Written informed consent to participate in the study must be obtained for all participants from the parent(s) or legal guardian.
- •In addition, for each cohort, the following Cohort Specific Inclusion Criteria must be met at Study Entry:
- •HIV-exposed neonates (pending HIV status) on standard of care ARV prophylaxis, as per local guidelines
- •< 14 days of age
- •Birth weight of =2500 g to ?4000 g
- •HIV-exposed neonates (pending HIV status) on standard of care ARV prophylaxis, as per local guidelines
- •= 3 days of age
- •Birth weight of =2000 to ?4000 g
- •HIV-exposed neonates (pending HIV status) who are at high risk of perinatal HIV transmission on standard of care ARV prophylaxis, as per local guidelines
- •= 3 days of age
- •Birth weight of =2000 to ?4000 g
排除标准
- •The presence of any of the following at entry, will exclude a subject from study enrolment:
- •Less than 37 weeks gestational age at birth
- •Baseline ECG has a QTc of > 0.45 sec
- •Haemoglobin value of < 13.0 g/dL
- •Hypokalemia (<3.6 mmol/L)
- •Hyperkalemia (>6.7 mmol/L)
- •Hyponatremia (<135 mmol/L)
- •Hypernatremia (>145 mmol/L)
- •A Creatinine value above the upper limit of normal for gestational age and postnatal age.
- •AST or ALT of more than 1.25 the upper limit of normal (ULN)
- •Total Bilirubin close to exchange value (based on local guidelines) or a high Bilirubin with red cell haemolysis
- •Any other Grade =3 event on the DAIDS toxicity table
- •Severe congenital abnormalities at investigator’s discretion
- •Receiving treatment for tuberculosis (TB)
- •Mothers on LPV-containing ARV treatment
- •Any medications known to induce QT interval prolongation
- •Critically ill infants at the discretion of the examining clinician
- •Participation in another clinical trial
- •HIV-infected neonates
- •Neonatal abstinence syndrome
研究者
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