Clinical Outcomes of People Who Acquired HIV in Early Life
- Conditions
- HIV
- Registration Number
- NCT01656564
- Brief Summary
Background:
- Long-term survival with the human immunodeficiency virus (HIV) is not well understood. Adults who were infected with HIV as children have lived with the virus for many years. However, the effect of HIV on this group of people has not been studied in depth. Researchers are interested in studying how HIV infection and the medicines used to treat it affect people who were infected early in life. They want to find out if there are any problems with how HIV-infected children grow and develop as adults, especially if they have developed heart problems. As part of this study, people with HIV will be compared with healthy volunteers.
Objectives:
- To study the effect of HIV infection and treatment on people who acquired HIV infection in early life.
Eligibility:
* Individuals at least 18 years of age who acquired HIV infection in early life.
* Healthy volunteers at least 18 years of age without HIV will serve as controls
Design:
* Participants will be screened with a physical exam and medical history. They will have regular study visits about once a year for up to 10 years to collect health information.
* Blood and urine samples will be collected to look at kidney and liver function.
* X-ray scans will be used to look at bone density and the amount of fat and muscle in the body.
* Treatment will not be provided as part of this study.
- Detailed Description
Background:
* Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
* Long-term survivors of pediatric HIV infection offer a tremendous opportunity to understand the effects of HIV and ART health outcomes.
* A thorough understanding of the impact of HIV and ART on these long-term processes is extremely relevant as ART programs for HIV-infected children expand globally.
Objective:
- To explore the clinical outcomes and the impact of HIV infection and ART on a cohort with HIV infection acquired in early life
Eligibility:
* Individuals at least 18 years of age who acquired HIV infection in early life
* Healthy volunteers without HIV (greater than or equal to 18 years of age) will serve as controls
Design:
- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health Status End of Study vital status and health outcomes will be determined annually throughout the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States