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Clinical Outcomes in Persons With HIV Acquired Early in Life

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ClinicalTrials.gov Identifier: NCT01656564
Recruitment Status : Recruiting
First Posted : August 3, 2012
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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 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.

Condition or disease
HIV Childhood Natural History Cardiac ART

Detailed 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 Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes in Persons With HIV Acquired Early in Life (COPE)
Study Start Date : July 11, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Patients
Individuals greater at least 18 years of age who acquired HIV infection in early life
Healthy Volunteers
Healthy volunteers without HIV (>=18 years of age) will serve as controls



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate reproductive health knowledge and decision making in this cohort compared to healthy controls [ Time Frame: Every 5 years ]
  2. To identify long-term infectious, cardiovascular and other noninfectious complications of HIV and ART in this cohort [ Time Frame: Annually ]


Information from the National Library of Medicine

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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
Study Population
Adolescents and adults infected with HIV in early life and age- sex-race matched healthy volunteers
Criteria
  • 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


Information from the National Library of Medicine

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


Contacts
Contact: Julia B Purdy, C.R.N.P. (301) 451-9109 purdyj@mail.nih.gov

Locations
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   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
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     History of Changes
Other Study ID Numbers: 120157
12-I-0157
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 1, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
HIV
Pediatric
ART
Longitudinal
Outcomes