Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 31
- 主要终点
- Clinical Outcome Measures - Weight measured in kg
研究概览
简要总结
IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated children who may participate in future research related to HIV remission or cure. Up to approximately 250 participants will be in the study for approximately seven years. No intervention is provided in the study.
详细描述
This is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to HIV remission or cure. Early treatment is defined as treatment with at least three ARV agents from at least two classes of ART initiated within 12 weeks of birth. Within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. A subset of children will have received bNAbs as part of their treatment regimens.
Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH) will be enrolled and followed semi-annually for up to seven years. Clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in one of the parent studies
- •Confirmed HIV-1 infection based on documented nucleic acid testing of two blood samples collected at different time points
- •Received early treatment for HIV-1 infection, defined as treatment with at least three ARV agents from at least two classes of ART, initiated within 12 weeks of birth
- •Based on parent or guardian report at entry, child is expected to be available for at least 24 months of follow-up
- •Parent or guardian is willing and able to provide written informed consent for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation
排除标准
- •Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe or otherwise interfere with completing study procedures
研究组 & 干预措施
Cohort 1
Children living with perinatally-acquired HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the United States National Institutes of Health.
干预措施: Cohort 1 (Other)
结局指标
主要结局
Clinical Outcome Measures - Weight measured in kg
时间窗: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of medical conditions that required hospitalization, resulted in persistent or significant disability or incapacity, were life threatening, or resulted in death
时间窗: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs
时间窗: At enrollment, at participant study completion (up until 7 years)
% of participants with HIV-1 DNA below the limit of detection of the assay among participants with quantifiable HIV-1 DNA, median and interquartile range
Clinical Outcome Measures - Height measured in cm
时间窗: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Weight-for-height Z score
时间窗: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition
Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest
时间窗: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Clinical Outcome Measures - Head circumference measured in cm
时间窗: At birth, 24 months of age
Median and interquartile range; to characterize long-term clinical profile
Immunologic Outcome Measures - CD8+ cell counts and percentages
时间窗: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term immunologic profile
Clinical Outcome Measures - Head circumference-for-age Z score
时间窗: At birth, 24 months of age
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of mortality
时间窗: At study participant completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Immunologic Outcome Measures - CD4+ cell counts and percentages
时间窗: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term immunologic profile
Virologic Outcome Measures - HIV-1 RNA in plasma
时间窗: At enrollment, at participant study completion (up until 7 years)
% of participants with HIV-1 RNA below the limit of detection of the assay among participants with quantifiable HIV-1 RNA, median and interquartile range
Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions
时间窗: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Virologic Outcome Measures - HIV-1 ARV resistance mutations
时间窗: At enrollment, at participant study completion (up until 7 years)
% of participants with resistance mutations
Immunologic Outcome Measures - HIV-1 antibody status
时间窗: At enrollment, at participant study completion (up until 7 years)
% of participants with negative serostatus
次要结局
未报告次要终点