Clinical Outcomes of People Who Acquired HIV in Early Life

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Outcomes in Persons With HIV Acquired Early in Life

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: HIV positive participants Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life Age greater than or equal to 18 years HIV negative controls HIV negative, documented by a negative ELISA Age greater than or equal to 18 years Free of any major underlying medical disorder Not currently pregnant For Reproductive Health Sub-Study: HIV positive participants Known HIV infection, confirmed by laboratory testing and documented or believed to have been acquired during the first decade of life Age greater than or equal to 18 years Capable of providing independent informed consent HIV negative controls HIV negative, verified by a negative ELISA Age greater than or equal to 18 years For Healthy Volunteer, Questionnaire Group only Age >=18 years No known history of HIV EXCLUSION CRITERIA: Clinically significant condition or 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Controls<br>Individuals with no known history of HIV | |
| Healthy Controls - Questionnaire Group<br>Individuals with no known history of HIV | |
| HIV<br>Individuals who acquired HIV in early life | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status | vital status and health outcomes will be determined annually throughout the study | End of Study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Childhood, Antiviral Therapy, Cardiac, Natural History