Clinical trial NCT01656564: Clinical Outcomes of People Who Acquired HIV in Early Life
Official title: Clinical Outcomes in Persons With HIV Acquired Early in Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Childhood
Antiviral Therapy
Cardiac
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2012-08-03
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected young adults; Healthy volunteers

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.

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.

Eligibility 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

For Healthy Volunteer, Questionnaire Group only

* Age \>=18 years
* No known history of HIV

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

Primary outcomes:
measure: Health Status
timeFrame: End of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Colleen M Hadigan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.