Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Assessment of Risk Factors of Nutritional and Metabolic Disorders in Children and Adolescent Receiving or Not Antiretroviral Treatment : Growing up With HIV in Senegal

Conditions
-----------------
HIV-1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of delayed growth | 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 | Baseline | 
| Prevalence of delayed puberty | Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging | Baseline | 
| Prevalence of lipodystrophy | 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 | Baseline | 
| Prevalence of blood lipids ans glucose abnormalities | Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides | Baseline | 
| Incidence of delayed growth | 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 | Annually for 3 years from the anniversary date of the study | 
| Incidence of delayed puberty | Assessed by age of entry into puberty and the age of transition to a different Tanner stage | Annually for 3 years from the anniversary date of the study | 
| Incidence of lipodystrophy | 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 | Annually for 3 years from the anniversary date of the study | 
| Incidence of blood lipid and glucose abnormalities | Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides | Annually for 3 years from the anniversary date of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, Child, Adolescent, Growth, Lipodystrophy, ARV treatment, Senegal