PACTR202607574273305进行中（未招募）2 期
A Phase 1/2 Trial Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of Subcutaneous ePGT121v1-LS, Added to Standard Antiretroviral Therapy in Infants Living With HIV
SERMAS Fundacion Hospital 12 de Octubre0 个研究点目标入组 87 人开始时间: 2027年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 87
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
- •Infants from 1 to 365 days old at the time of enrolment.
- •Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood.
- •Weight > 2.5 kg at enrolment.
- •ART-naïve or = 30 days of triple ART at screening (not including prophylaxis in HIV-exposed).
- •Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit).
- •Parent or legal guardian provides Informed consent (IC).
排除标准
- •Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study.
- •Previous receipt of bNAbs against HIV.
- •Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components.
- •Intravenous (IV) immunoglobulins received within 90 days before IMP administration.
- •Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights
- •of the participant. Including, but not restricted to:
- •Evidence of active tuberculosis (TB) disease at the time of enrolment.
- •Life-threatening condition associated with a high risk of death within 30
- •days of enrolment, as determined by the study clinician.
- •Severe acute malnutrition with complications.
- •Severe neurological illness.
- •Hemodynamically significant severe congenital heart disease.
- •Active malignancies.
- •Life-threatening bleeding disorder.
- •Use of systemic immunosuppressive drugs within 30 days before first IMP
- •administration. Not exclusionary: nasal steroid spray, inhaled steroids,
- •topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy <14 days.
- •Unwillingness to have blood drawn
- •Unable to receive SC medications.
- •Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs).
- •Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.
研究者
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