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Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

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ClinicalTrials.gov Identifier: NCT01771562
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Tracking Information
First Submitted Date January 16, 2013
First Posted Date January 18, 2013
Last Update Posted Date May 20, 2016
Study Start Date April 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2013)
  • 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
  • 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
  • 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
  • Prevalence of blood lipids ans glucose abnormalities [ Time Frame: Baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent
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
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
Plasma, blood cells and urine samples to be retained
Sampling Method Non-Probability Sample
Study Population HIV-1 infected individuals age between 2 ans 16 years
Condition HIV-1
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2016)
330
Original Estimated Enrollment
 (submitted: January 16, 2013)
400
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Senegal
Removed Location Countries  
 
Administrative Information
NCT Number NCT01771562
Other Study ID Numbers ANRS 12279 MAGGSEN
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ANRS, Emerging Infectious Diseases
Study Sponsor ANRS, Emerging Infectious Diseases
Collaborators Not Provided
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
PRS Account ANRS, Emerging Infectious Diseases
Verification Date May 2016