Clinical trial NCT01771562: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1
Keywords: HIV-1
Child
Adolescent
Growth
Lipodystrophy
ARV treatment
Senegal
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2013-01-18
Enrollment: 330
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected individuals age between 2 ans 16 years

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.


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

Primary outcomes:
measure: Prevalence of delayed growth
timeFrame: Baseline
measure: Prevalence of delayed puberty
timeFrame: Baseline
measure: Prevalence of lipodystrophy
timeFrame: Baseline
measure: Prevalence of blood lipids ans glucose abnormalities
timeFrame: Baseline
measure: Incidence of delayed growth
timeFrame: Annually for 3 years from the anniversary date of the study
measure: Incidence of delayed puberty
timeFrame: Annually for 3 years from the anniversary date of the study
measure: Incidence of lipodystrophy
timeFrame: Annually for 3 years from the anniversary date of the study
measure: Incidence of blood lipid and glucose abnormalities
timeFrame: Annually for 3 years from the anniversary date of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: Hôpital d'enfant Albert Royer
city: Guédiawaye
country: Senegal
facility: Hôpital Roi Baudoin
Study officials:
affiliation: IRD : French Research Institute for Development
name: Philippe Msellati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital d'Enfant Albert Royer, Dakar, Senegal
name: Haby Sy Signate, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Roi Baudoin, Guédiawaye, Senegal
name: Ngagne Mbaye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cames C, Pascal L, Ba A, Mbodj H, Ouattara B, Diallo NF, Msellati P, Mbaye N, Sy Signate H, Blanche S, Diack A; MAGGSEN Cohort Study Group. Low prevalence of lipodystrophy in HIV-infected Senegalese children on long-term antiretroviral treatment: the ANRS 12279 MAGGSEN Pediatric Cohort Study. BMC Infect Dis. 2018 Aug 6;18(1):374. doi: 10.1186/s12879-018-3282-7.
citation: Cames C, Varloteaux M, Have NN, Diom AB, Msellati P, Mbaye N, Mbodj H, Sy Signate H, Diack A; ANRS 12279 MAGGSEN Cohort Study Group. Acceptability of Outpatient Ready-To-Use Food-Based Protocols in HIV-Infected Senegalese Children and Adolescents Within the MAGGSEN Cohort Study. Food Nutr Bull. 2017 Mar;38(1):27-36. doi: 10.1177/0379572116679053. Epub 2016 Nov 23.