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

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ClinicalTrials.gov Identifier: NCT01555723
Recruitment Status : Withdrawn (New study created.)
First Posted : March 15, 2012
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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.


Condition or disease
HIV Infection

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Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV (Human Immunodeficiency Virus) Subtype and ARV Response in African Children

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Plasma obtained fron participants

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT01555723


Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Frank M Graziano, MD PhD U Wisconsin
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01555723     History of Changes
Other Study ID Numbers: RELATES
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases