Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01771562 |
Recruitment Status
:
Completed
First Posted
: January 18, 2013
Last Update Posted
: May 20, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV-1 |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 330 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
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 : | April 2013 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |
- 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
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771562
Senegal | |
Hôpital d'enfant Albert Royer | |
Dakar, Senegal | |
Hôpital Roi Baudoin | |
Guédiawaye, Senegal |
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
ClinicalTrials.gov Identifier: | NCT01771562 History of Changes |
Other Study ID Numbers: |
ANRS 12279 MAGGSEN |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | May 20, 2016 |
Last Verified: | May 2016 |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-1 Child Adolescent Growth |
Lipodystrophy ARV treatment Senegal |
Additional relevant MeSH terms:
Metabolic Diseases |