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NCT00075153 Clinical Trial

Quality of Life in Children With HIV Infection

HIV Infections Clinical Trial

Official title:
Quality of Life in Children With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00075153
Other study ID # 1R01NR007975-01
Secondary ID R01NR007975
Status Completed
Phase N/A
First received January 2, 2004
Last updated April 21, 2014
Start date September 2001
Est. completion date July 2008

Study information
Verified date April 2014
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this study is to characterize the quality of life (QOL) and longitudinal patterns of change in QOL outcomes in children and youth with HIV infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in QOL; and to characterize the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

Description:

This is a Phase III study. This study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about the quality of life (QOL) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve QOL in this vulnerable population of children.

Recruitment information / eligibility
Status Completed
Enrollment 1993
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 10 Months to 25 Years
Eligibility Inclusion criteria

- Children and youth with perinatally acquired HIV infection

- Enrolled in PACTG 219/219C

- Completed quality of life assessment

Exclusion criteria

--HIV exposed, not infected

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Medicine and Dentistry of NJ Newark New Jersey

Sponsors (2)
Lead Sponsor Collaborator
University of Medicine and Dentistry of New Jersey National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life assessment 1999 No
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