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Completed

NCT Number: NCT01771562

Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

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.

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Key information

Conditions

HIV-1 Lipid Metabolism Disorders Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'enfant Albert Royer, Dakar, Senegal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of delayed growth

    Time frame: 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

  2. Prevalence of delayed puberty

    Time frame: Baseline

    Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging

  3. Prevalence of lipodystrophy

    Time frame: 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

  4. Prevalence of blood lipids ans glucose abnormalities

    Time frame: Baseline

    Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides

  5. Incidence of delayed growth

    Time frame: 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

  6. Incidence of delayed puberty

    Time frame: 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

  7. Incidence of lipodystrophy

    Time frame: 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

  8. Incidence of blood lipid and glucose abnormalities

    Time frame: Annually for 3 years from the anniversary date of the study

    Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2013
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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