Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

HIV-1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771562
• Other study ID #: ANRS 12279 MAGGSEN
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: May 19, 2016
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministry of Health and Social Action
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV-1
• Metabolic Diseases

Locations

Country	Name	City	State
Senegal	Hôpital d'enfant Albert Royer	Dakar
Senegal	Hôpital Roi Baudoin	Guédiawaye

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of delayed growth	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	Baseline	No
Primary	Prevalence of delayed puberty	Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging	Baseline	No
Primary	Prevalence of lipodystrophy	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	Baseline	No
Primary	Prevalence of blood lipids ans glucose abnormalities	Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides	Baseline	No
Primary	Incidence of delayed growth	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	Annually for 3 years from the anniversary date of the study	No
Primary	Incidence of delayed puberty	Assessed by age of entry into puberty and the age of transition to a different Tanner stage	Annually for 3 years from the anniversary date of the study	No
Primary	Incidence of lipodystrophy	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	Annually for 3 years from the anniversary date of the study	No
Primary	Incidence of blood lipid and glucose abnormalities	Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides	Annually for 3 years from the anniversary date of the study	No

External Links

•   Sponsor website