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Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

This study has been completed.
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: May 19, 2016
Last verified: May 2016
  Purpose
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.

Condition
HIV-1

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Plasma, blood cells and urine samples to be retained

Enrollment: 330
Study Start Date: April 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-1 infected individuals age between 2 ans 16 years
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771562

Locations
Senegal
Hôpital d'enfant Albert Royer
Dakar, Senegal
Hôpital Roi Baudoin
Guédiawaye, Senegal
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
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
  More Information

Additional Information:
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     History of Changes
Other Study ID Numbers: ANRS 12279 MAGGSEN 
Study First Received: January 16, 2013
Last Updated: May 19, 2016
Health Authority: Senegal: Ministry of Health and Social Action

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-1
Child
Adolescent
Growth
Lipodystrophy
ARV treatment
Senegal

Additional relevant MeSH terms:
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2016