Clinical Outcomes of People Who Acquired HIV in Early Life
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ClinicalTrials.gov Identifier: NCT01656564 |
Recruitment Status :
Recruiting
First Posted : August 3, 2012
Last Update Posted : October 22, 2020
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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 who have no history of heart disease.
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.
Condition or disease |
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HIV |
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 Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Clinical Outcomes of Persons With HIV Acquired Early in Life |
Actual Study Start Date : | August 27, 2012 |
Group/Cohort |
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HIV
Individuals who acquired HIV in early life
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- Health Status [ Time Frame: End of Study ]vital status and health outcomes will be determined annually throughout the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
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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
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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:
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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
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HIV negative controls
- HIV negative, verified by a negative ELISA
- Age greater than or equal to 18 years
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656564
Contact: Julia B Purdy, C.R.N.P. | (301) 451-9109 | purdyj@mail.nih.gov |
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 prpl@cc.nih.gov |
Principal Investigator: | Colleen M Hadigan, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01656564 |
Other Study ID Numbers: |
120157 12-I-0157 |
First Posted: | August 3, 2012 Key Record Dates |
Last Update Posted: | October 22, 2020 |
Last Verified: | October 9, 2020 |
HIV Childhood Antiviral Therapy Cardiac Natural History |