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

NCT01555723 | Withdrawn

• 1 other identifier: RELATES
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infection

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Biospecimen

Retention: SAMPLES WITH DNA

Plasma obtained fron participants

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Frank M Graziano, MD PhD

  U Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: March 15, 2012
• Last Updated: October 1, 2015

Record last verified: 2015-09