Clinical Outcomes in Persons With HIV Acquired Early in Life
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01656564|
Recruitment Status : Recruiting
First Posted : August 3, 2012
Last Update Posted : May 24, 2018
- 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.
- To study the effect of HIV infection and treatment on people who acquired HIV infection in early life.
- Individuals at least 18 years of age who were infected with HIV before age 10.
- Healthy volunteers at least 18 years of age who have no history of heart disease.
- 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.
- Heart function tests and imaging studies, including ultrasound and echocardiograms, will be used to look more closely at the heart.
- Treatment will not be provided as part of this study.
|Condition or disease|
|HIV Childhood Natural History Cardiac ART|
- Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
- Longterm 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.
- To explore the clinical outcomes and the impact of HIV infection and ART on a cohort with HIV infection acquired in early life.
- Individuals greater than 18 yrs of age who acquired HIV infection in early life.
- Individuals previously enrolled in Protocol 07-C-0087 (A natural history study of HIV acquired in infancy or childhood) will be offered enrollment in this study.
- Healthy volunteers without HIV (>18 years of age) will serve as controls.
- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted. In addition, a subset of participants will complete a detailed cardiac evaluation with imaging which may be repeated every 5 years.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Clinical Outcomes in Persons With HIV Acquired Early in Life (COPE)|
|Study Start Date :||July 11, 2012|
- To explore the clinical outcomes and the impact of HIV infection and antiretroviral therapy on a cohort with HIV infection acquired in early life. [ Time Frame: Annually ]
- To evaluate the prevalence and the extent of cardiac abnormalities in this population compared to healthy controls using non-invasive MR and CT imaging [ Time Frame: Every 5 years ]
- To identify long-term infectious and non-infectious complications of HIV and ART in this cohort [ Time Frame: Annually ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656564
|Contact: Julia B Purdy, C.R.N.P.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Colleen M Hadigan, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|