IMPAACT P1074: Long-Term Outcomes in HIV-Infected Infants, Children, and Adolescents
This study will examine the long-term effects of HIV infection, highly active antiretroviral therapy (HAART), and experimental treatments on children who participated in PACTG 219C or select IMPAACT studies.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Surveillance Study of Long-Term Outcomes in HIV-Infected Infants, Children and Adolescents|
- To identify possible long-term adverse outcomes of HIV infection and complications of antiretroviral therapy (ART) or experimental interventions other than ARTs in HIV-infected infants, children, and adolescents at IMPAACT sites in the United States [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
HIV-infected infants, children, and adolescents
Infants, children, and adolescents with HIV infection who have participated in PACTG 219C and/or select IMPAACT studies.
The use of HAART has been important in extending the lives of people with HIV infection. However, prolonged use of HAART may have long-term consequences. In addition, people participating in clinical trials using experimental therapies to treat HIV infection may experience negative health outcomes. The purpose of this study is to identify the long-term effects of HIV infection, HAART, and experimental treatments in infants, children, and adolescents.
This study will enroll children who participated in PACTG 219C or various IMPAACT studies. There will be no study visits specifically for this study. Researchers will review participants' medical records annually and collect information on illnesses, medications, CD4 cell count and viral load data, and body measurements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061164
Show 39 Study Locations
|Study Chair:||Myron J. Levin, MD||University of Colorado at Denver Health Sciences Center|
|Study Chair:||Paige L. Williams, PhD||Harvard School of Public Health|