Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT01771562

Collaborator

(none)

330

Enrollment

Locations

Duration (Months)

165

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

330 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Outcome Measures

Primary Outcome Measures

Prevalence of delayed growth [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 [Baseline]
Delayed puberty is assessed by age of entry into puberty and the age of transition to different Tanner staging
Prevalence of lipodystrophy [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 [Baseline]
Measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides
Incidence of delayed growth [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 [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 [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 [Annually for 3 years from the anniversary date of the study]
Repeated measurement of blood glucose, total cholesterol, HDL, LDL and triglycerides

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hôpital d'enfant Albert Royer	Dakar		Senegal
2	Hôpital Roi Baudoin	Guédiawaye		Senegal

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases

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