Clinical Outcomes in Persons With HIV Acquired Early in Life
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | July 11, 2012 |
| Contact: | Julia B Purdy, C.R.N.P. |
| Email: | purdyj@mail.nih.gov |
| Phone: | (301) 451-9109 |
Clinical Outcomes in Persons With HIV Acquired Early in Life (COPE)
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.
- 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.
- 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.
- 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.
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.
- 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.
- 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
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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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