Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

Completed

• Conditions: HIV-1

• Registration Number: NCT01771562
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of delayed growth	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	Baseline	Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Prevalence of lipodystrophy	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	Baseline	Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Incidence of delayed growth	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	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	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	Annually for 3 years from the anniversary date of the study	Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides

Trial Locations

Locations (2)

Hôpital Roi Baudoin; 🇸🇳 Guédiawaye, Senegal

Hôpital d'enfant Albert Royer; 🇸🇳 Dakar, Senegal