Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01771562
First received: January 16, 2013
Last updated: April 3, 2013
Last verified: April 2013

January 16, 2013
April 3, 2013
April 2013
April 2016   (final data collection date for primary outcome measure)
  • Prevalence of delayed growth [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
  • Prevalence of lipodystrophy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
  • Incidence of delayed growth [ Time Frame: Annually for 3 years from the anniversary date of the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: Annually for 3 years from the anniversary date of the study ] [ Designated as safety issue: No ]
    Assessed by age of entry into puberty and the age of transition to a different Tanner stage
  • Incidence of lipodystrophy [ Time Frame: Annually for 3 years from the anniversary date of the study ] [ Designated as safety issue: No ]
    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 [ Time Frame: Annually for 3 years from the anniversary date of the study ] [ Designated as safety issue: No ]
    Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Same as current
Complete list of historical versions of study NCT01771562 on ClinicalTrials.gov Archive Site
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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

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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Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Years
Retention:   Samples With DNA
Description:

Plasma, blood cells and urine samples to be retained

Non-Probability Sample

HIV-1 infected individuals age between 2 ans 16 years

HIV-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
2 Years to 15 Years
No
Senegal
 
NCT01771562
ANRS 12279 MAGGSEN
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Philippe Msellati, MD IRD : French Research Institute for Development
Principal Investigator: Haby Sy Signate, MD Hôpital d'Enfant Albert Royer, Dakar, Senegal
Principal Investigator: Ngagne Mbaye, MD Hôpital Roi Baudoin, Guédiawaye, Senegal
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP