Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

NCT ID: NCT01771562

Last Updated: 2016-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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HIV-1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Msellati, MD

Role: PRINCIPAL_INVESTIGATOR

IRD : French Research Institute for Development

Haby Sy Signate, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital d'Enfant Albert Royer, Dakar, Senegal

Ngagne Mbaye, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Roi Baudoin, Guédiawaye, Senegal

Locations

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Hôpital d'enfant Albert Royer

Dakar, , Senegal

Site Status

Hôpital Roi Baudoin

Guédiawaye, , Senegal

Site Status

Countries

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Senegal

References

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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.

Reference Type DERIVED
PMID: 30081838 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27881690 (View on PubMed)

Related Links

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http://www.anrs.fr

Sponsor website

Other Identifiers

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ANRS 12279 MAGGSEN

Identifier Type: -

Identifier Source: org_study_id

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