Trial record 1 of 1 for:
NCT01771562
Nutritional and Metabolic Disorders in HIV Infected Children and Adolescent
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| ClinicalTrials.gov Identifier: NCT01771562 |
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Recruitment Status :
Completed
First Posted : January 18, 2013
Last Update Posted : May 20, 2016
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Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases ( French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) )
| Tracking Information | ||||||||||
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| First Submitted Date | January 16, 2013 | |||||||||
| First Posted Date | January 18, 2013 | |||||||||
| Last Update Posted Date | May 20, 2016 | |||||||||
| Study Start Date | April 2013 | |||||||||
| Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | 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 | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 3 Years | |||||||||
| Biospecimen | Retention: Samples With DNA Description: Plasma, blood cells and urine samples to be retained
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| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | HIV-1 infected individuals age between 2 ans 16 years | |||||||||
| Condition | HIV-1 | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
330 | |||||||||
| Original Estimated Enrollment |
400 | |||||||||
| Actual Study Completion Date | April 2016 | |||||||||
| Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 2 Years to 15 Years (Child) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Senegal | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT01771562 | |||||||||
| Other Study ID Numbers | ANRS 12279 MAGGSEN | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | ANRS, Emerging Infectious Diseases ( French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ) | |||||||||
| Study Sponsor | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | ANRS, Emerging Infectious Diseases | |||||||||
| Verification Date | May 2016 | |||||||||