HIV Clinical Trial - Clinical Outcomes of People Who Acquired HIV in Early

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01656564
Study type	Observational
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase
Start date	August 27, 2012
Completion date	March 8, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Outcomes of People Who Acquired HIV in Early Life

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms