Observational Study of Antiretroviral (ARV) Response in a Cohort of African Children Using Viral Load Monitoring (RELATES)
|ClinicalTrials.gov Identifier: NCT01555723|
Recruitment Status : Withdrawn (New study created.)
First Posted : March 15, 2012
Last Update Posted : October 1, 2015
Background: Treatment of HIV-1 infected Ugandan children with antiretroviral therapy (ART) is increasing but few prospective long-term studies evaluating the treatment process have been reported. In this study we sought to determine prospectively how consistent monitoring of HIV-1 RNA levels impacts the ART treatment process.
Methods: One hundred and eight children initiating ART were enrolled into this study. These children had comprehensive laboratory monitoring including HIV-1 RNA level determination and genotype analysis (where appropriate), CD4 % plus absolute counts, and safety laboratory measurements performed prior to starting therapy and at regular intervals after receiving ART. Kaplan-Meier statistics were used to examine predictors of survival and virologic failure. Viral genotype analysis was performed on samples obtained from children having virologic failure to determent the emergence of mutations.
|Condition or disease|
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|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||HIV (Human Immunodeficiency Virus) Subtype and ARV Response in African Children|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555723
|Principal Investigator:||Frank M Graziano, MD PhD||U Wisconsin|