Assessment of Risk Factors of Nutritional and Metabolic Disorders in Children and Adolescent Receiving or Not Antiretroviral Treatment : Growing up With HIV in Senegal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Prevalence of delayed growth
研究概览
简要总结
The advent of highly active antiretroviral treatment has resulted in the survival into adolescence of an increasing proportion of infants and children with perinatal HIV infection in Senegal. However, the transformation of HIV into a chronic disease needing lifelong antiretroviral treatment (ART) raises new challenges, among others related to a disturbance of glucose metabolism, lipid abnormalities, in addition to the potential effects on children's growth and puberty. Little is known on nutritional and metabolic changes in HIV-infected children on ART in Africa, while implementation of the latest WHO recommendations should eventually lead to an increase in the number of children on ART in this region. Moreover, bio-clinical evolution of untreated children is poorly documented in the African context. It therefore urgently needed to institute a cohort study to evaluate, in the long term, the impact of HIV infection and/or ART on nutritional and metabolic disorders and to characterize the risk factors of their occurrence in children and adolescents infected as they move through adolescent into adulthood.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •Age equal or above 2 years and bellow 16 years
- •Follow-up in the participating site
- •Informed consent signed by at least on of the parents or legal guardian who is aware of the child's HIV status
排除标准
- •HIV-2 or HIV-1+2 infection
- •children represented by a legal guardian who is not informed about the child's HIV status
- •Unable to comply with study requirements or procedures according to the investigator's opinion
结局指标
主要结局
Prevalence of delayed growth
时间窗: Baseline
Delayed growth is defined by height for age \< -2 z-scores, wasting (%) by weight-for height \< -2 z-scores and/or BMI-age \< -2 z-scores
Prevalence of delayed puberty
时间窗: Baseline
Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Prevalence of lipodystrophy
时间窗: Baseline
Lipodystrophy (lipoatrophy, lipohypertrophy, combined forms) is defined by direct observation and by joint analysis of anthropometric measures associated with fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Prevalence of blood lipids ans glucose abnormalities
时间窗: Baseline
Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Incidence of delayed growth
时间窗: Annually for 3 years from the anniversary date of the study
Delayed growth is defined by height for age \< -2 z-scores, wasting (%) by weight-for height \< -2 z-scores and/or BMI-age \< -2 z-scores
Incidence of delayed puberty
时间窗: Annually for 3 years from the anniversary date of the study
Assessed by age of entry into puberty and the age of transition to a different Tanner stage
Incidence of lipodystrophy
时间窗: Annually for 3 years from the anniversary date of the study
defined by direct observation and by joint analysis of anthropometric measures associated with changes in fat tissue index and lean tissue index measured by electrical bio-impedancemetry
Incidence of blood lipid and glucose abnormalities
时间窗: Annually for 3 years from the anniversary date of the study
Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
次要结局
未报告次要终点