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Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01771562
Enrollment
330
Registered
2013-01-18
Start date
2013-04-30
Completion date
2016-04-30
Last updated
2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-1

Keywords

HIV-1, Child, Adolescent, Growth, Lipodystrophy, ARV treatment, Senegal

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.

Interventions

None listed

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of blood lipid and glucose abnormalitiesAnnually for 3 years from the anniversary date of the studyRepeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Prevalence of delayed growthBaselineDelayed 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 pubertyBaselineDelayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Prevalence of lipodystrophyBaselineLipodystrophy (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 abnormalitiesBaselineMeasurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Incidence of delayed growthAnnually for 3 years from the anniversary date of the studyDelayed 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 pubertyAnnually for 3 years from the anniversary date of the studyAssessed by age of entry into puberty and the age of transition to a different Tanner stage
Incidence of lipodystrophyAnnually for 3 years from the anniversary date of the studydefined 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

Countries

Senegal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026