HIV Infections
Conditions
Keywords
Children, AIDS, Toxicity, Development, Puberty, HIV, Pediatrics, HIV Infections
Brief summary
Background: * About 10,000 children in the United States have been living with HIV infection since birth. Little is known about the long-term effects of HIV infection and its treatment on the growth and development of these children. * Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships. Objectives: * To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young. * To develop ways to improve the quality of life for these individuals. Eligibility: -HIV-infected patients who were followed by the pediatric HIV program in NCI as of December 2004, or an HIV-infected sibling of a participant. Design: * Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following: * Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat. * Review of medical records and family history. * Blood and urine tests, including pregnancy test in females who can bear children. * DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body). * Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities. * Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function. * Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar
Detailed description
Background: Highly active antiretroviral therapy (HAART) has altered the natural history of HIV disease in children. The pediatric cohort in this country offers a tremendous opportunity to understand the effect of HIV and ARTs on key developmental and maturational processes. A thorough understanding of the impact of HIV and ARTs on these long-term processes is extremely relevant as ART programs for HIV-infected children are being developed around the world. Objective: To explore the clinical features and impact of HIV infection and antiretroviral therapy in an HIV-infected pediatric cohort. Eligibility: Known HIV disease and followed in the NCI pediatric HIV program as of December 2004, or HIV-infected sibling of a participant. Elgibility for the cardiac sub-study is expanded to include any person with HIV acquired in infancy or young childhood who is older than 7 and meets other inclusion criteria. Eligibility for cardiac sub-study will also include HIV uninfected subjects (18-30 years of age) who will server as a control group. Design: Serial evaluations of pubertal development, bone mineralization, body composition and fat distribution, hepatic, renal, and cardiac status, and behavioral, cognitive, and academic/vocational outcome. Findings may be shared with the multicenter Pediatric HIV/AIDS Cohort Study and lead to more intensive, focused substudies.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* INCLUSION CRITERIA: Known HIV disease and followed in the NCI pediatric HIV program (on an NCI protocol) as of December 2004, or an HIV-infected sibling of a participant. Age greater than 6 years. For children greater than 7 years, ability to give assent if developmentally appropriate. Receives care from a health care provider not affiliated with the protocol. INCLUSION CRITERIA FOR CARDIAC IMAGING SUB-STUDY: HIV positive participants * Known HIV disease, documented or believed to have been acquired during the first decade of life * Age greater than 7 years old HIV negative participants * HIV negative, documented by a negative ELISA * Age greater than or equal to 18 years old and less than or equal to 30 years old
Exclusion criteria
Inability or unwillingness to provide informed consent for subjects greater than or equal to 18 years, and inability or unwillingness of one parent/legal guardian to provide consent for subjects less than 18 years. Clinically significant, systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate this study.
Countries
United States
Outcome results
None listed