Clinical Outcomes of People Who Acquired HIV in Early Life

NCT01656564 | Completed

• 2 other identifiers: 12015712-I-0157
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV

Keywords

HIV; Childhood; Antiviral Therapy; Cardiac; Natural History

Outcome Measures

Primary Outcomes (1)

• Health Status

  vital status and health outcomes will be determined annually throughout the study

  End of Study

Study Arms (3)

Healthy Controls

Individuals with no known history of HIV

Healthy Controls - Questionnaire Group

Individuals with no known history of HIV

HIV

Individuals who acquired HIV in early life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected young adults; Healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

• Aepfelbacher JA, Chaudhury CS, Mee T, Purdy JB, Hawkins K, Curl KA, Dee N, Hadigan C. Reproductive and sexual health knowledge, experiences, and milestones in young adults with life-long HIV. AIDS Care. 2020 Mar;32(3):354-361. doi: 10.1080/09540121.2019.1679711. Epub 2019 Oct 22.

  PMID: 31640401 BACKGROUND

• Abd-Elmoniem KZ, Ishaq H, Purdy J, Matta J, Hamimi A, Hannoush H, Hadigan C, Gharib AM. Association of Coronary Wall Thickening and Diminished Diastolic Function in Asymptomatic, Low Cardiovascular Disease-Risk Persons Living with HIV. Radiol Cardiothorac Imaging. 2024 Apr;6(2):e230102. doi: 10.1148/ryct.230102.

  PMID: 38573125 DERIVED

• Sahagun SJ, Yeramosu T, Purdy JB, Reynolds JC, Hadigan CM. Associations Between Central Obesity and Lifelong Antiviral Therapy in Adults Living With HIV Acquired From Early Childhood. J Acquir Immune Defic Syndr. 2022 Feb 1;89(2):208-214. doi: 10.1097/QAI.0000000000002841.

  PMID: 34693931 DERIVED

• Aepfelbacher JA, Balmaceda J, Purdy J, Mattingly A, Zambell K, Hawkins K, Chairez C, Curl KA, Dee N, Hadigan C. Increased Prevalence of Hepatic Steatosis in Young Adults With Lifelong HIV. J Infect Dis. 2019 Jun 19;220(2):266-269. doi: 10.1093/infdis/jiz096.

  PMID: 30852587 DERIVED

• Unsal AB, Mattingly AS, Jones SE, Purdy JB, Reynolds JC, Kopp JB, Hazra R, Hadigan CM. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2896-2904. doi: 10.1210/jc.2017-00197.

  PMID: 28531309 DERIVED

• Mattingly AS, Unsal AB, Purdy JB, Gharib AM, Rupert A, Kovacs JA, McAreavey D, Hazra R, Abd-Elmoniem KZ, Hadigan C. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults. Pediatr Infect Dis J. 2017 Jan;36(1):63-65. doi: 10.1097/INF.0000000000001354.

  PMID: 27749650 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Colleen M Hadigan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 3, 2012
• Study Start: August 27, 2012
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)