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Observational Study of Antiretroviral (ARV) Response in a Cohort of African Children Using Viral Load Monitoring

NCT01555723 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-10-01

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infection

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Frank M Graziano, MD PhD · U Wisconsin

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555723 on ClinicalTrials.gov