Clinical Outcomes of People Who Acquired HIV in Early Life

• ClinicalTrials.gov Identifier: NCT01656564
• Recruitment Status: Recruiting
• First Posted: August 3, 2012
• Last Update Posted: August 6, 2020
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description

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.
• Treatment will not be provided as part of this study....

Condition or disease
HIV

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 Design

• 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 (COPE)
• Actual Study Start Date: August 27, 2012

Groups and Cohorts

Group/Cohort
Healthy Volunteers; Age, sex, race-matched healthy volunteers
HIV; Individuals who acquired HIV in early life

Outcome Measures

Primary Outcome Measures :

1. Health Status [ Time Frame: End of Study ]
   vital status and health outcomes will be determined annually throughout the study

Eligibility Criteria

• 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

HIV infected young adults

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

Contacts and Locations

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)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications:

Holtgrave DR. Causes of the decline in AIDS deaths, United States, 1995-2002: prevention, treatment or both? Int J STD AIDS. 2005 Dec;16(12):777-81. Review.

Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. Review.

Sims A, Hadigan C. Cardiovascular complications in children with HIV infection. Curr HIV/AIDS Rep. 2011 Sep;8(3):209-14. doi: 10.1007/s11904-011-0081-9. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• 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
• Last Update Posted: August 6, 2020
• Last Verified: July 24, 2020

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

HIV; Childhood; Antiviral Therapy; Cardiac; Natural History