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

This study has been withdrawn prior to enrollment.
(New study created.)
Sponsor:
Information provided by (Responsible Party):
Frank Graziano, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01555723
First received: June 2, 2008
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV (Human Immunodeficiency Virus) Subtype and ARV Response in African Children

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Biospecimen Retention:   Samples With DNA

Plasma obtained fron participants
Enrollment: 0
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria: Starting in 2008 children between the ages of 6 weeks and 18 years having confirmed HIV infection and receiving no ART were consecutively enrolled into this observational cohort study following consent and/or assent (where applicable).

Exclusion Criteria: Children were excluded from participation if they were enrolled in another cohort study, or had psychosocial issues precluding participation (no parent or guardian willing to promote ART adherence or clinic HIV counselor evaluation of non adherence). The enrollment goal for this study was approximately100 children recruited over a period of 8 months.

Criteria

Inclusion Criteria:

  • Children between the ages of 6 weeks and 18 years having confirmed HIV infection
  • Receiving no ART were consecutively enrolled into this observational study
  • Consent and/or assent (where applicable) had to be obtained.

Exclusion Criteria:

  • Children were enrolled in another cohort study
  • Had psychosocial issues precluding participation (no parent or guardian willing to promote ART adherence or clinic HIV counselor evaluation of non adherence).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555723

Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Frank M Graziano, MD PhD U Wisconsin
  More Information

No publications provided

Responsible Party: Frank Graziano, Professor of Medicine, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01555723     History of Changes
Other Study ID Numbers: RELATES
Study First Received: June 2, 2008
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015