Protocol Number: 07-C-0087

Title:

A Natural History Study of HIV Acquired in Infancy or Childhood

Number:

07-C-0087

Summary:

Background:

-About 10,000 children in the United States have been living with HIV infection since birth. Little is known about the long-term effects of HIV infection and its treatment on the growth and development of these children.

-Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships.

Objectives:

-To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young.

-To develop ways to improve the quality of life for these individuals.

Eligibility:

-HIV-infected patients who were followed by the pediatric HIV program in NCI as of December 2004, or an HIV-infected sibling of a participant.

Design:

-Periodic evaluation of pubertal development, bone mineralization, body composition and fat distribution, liver, kidney and heart status, and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following:

-Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat.

-Review of medical records and family history.

-Blood and urine tests, including pregnancy test in females who can bear children.

-DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body).

-Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities.

-Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function.

-Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Known HIV disease and followed in the NCI pediatric HIV program (on an NCI protocol) as of December 2004, or an HIV-infected sibling of a participant.

Age greater than or equal to 6 years.

For children greater than 7 years, ability to give assent if developmentally appropriate.

Receives care from a health care provider not affiliated with the protocol.

EXCLUSION CRITERIA:

Inability or unwillingness to provide informed consent for subjects greater than or equal to 18 years, and inability or unwillingness of one parent/legal guardian to provide consent for subjects less than 18 years.

Clinically significant, 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.

EXCLUSION CRITERIA FOR CARDIAC IMAGING SUB-STUDY:

Subjects with contraindication to MRI scanning. These include but are not limited to the presence of any implanted device that is incompatible with MRI.

Subjects who cnnot tolerate an MRI scan or who require sedation for MRI.

Pregnant or lactating women.

History of severe allergic reaction to gadolinium contrast agents.

Estimated glomerular filtration rate less than 60 cc/min/1.73m(2).

Special Instructions:

Currently Not Provided

Keywords:

Children

AIDS

Toxicity

Development

Puberty

Recruitment Keyword(s):

HIV

Children

Pediatrics

Condition(s):

HIV

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

Recruitment Center - SB
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Building 10, Room 2-1730, Bethesda, Maryland 20892, United States
Phone: (866) 820-4505
Fax: (301) 451-1927
Electronic Address: ncisbirc@mail.nih.gov

Citation(s):

Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8.

Abrams EJ, Weedon J, Bertolli J, Bornschlegel K, Cervia J, Mendez H, Lambert G, Singh T, Thomas P; New York City Pediatric Surveillance of Disease Consortium. Centers for Disease Control and Prevention. Aging cohort of perinatally human immunodeficiency virus-infected children in New York City. New York City Pediatric Surveillance of Disease Consortium. Pediatr Infect Dis J. 2001 May;20(5):511-7.

Belman AL, Ultmann MH, Horoupian D, Novick B, Spiro AJ, Rubinstein A, Kurtzberg D, Cone-Wesson B. Neurological complications in infants and children with acquired immune deficiency syndrome. Ann Neurol. 1985 Nov;18(5):560-6.

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