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A Natural History Study of HIV Acquired in Infancy or Childhood


N/A
6 Years
N/A
Open (Enrolling)
Both
HIV Infections

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Trial Information

A Natural History Study of HIV Acquired in Infancy or Childhood


Background:

Highly active antiretroviral therapy (HAART) has altered the natural history of HIV disease
in children.

The pediatric cohort in this country offers a tremendous opportunity to understand the
effect of HIV and ARTs on key developmental and maturational processes.

A thorough understanding of the impact of HIV and ARTs on these long-term processes is
extremely relevant as ART programs for HIV-infected children are being developed around the
world.

Objective:

To explore the clinical features and impact of HIV infection and antiretroviral therapy in
an HIV-infected pediatric cohort.

Eligibility:

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

Elgibility for the cardiac sub-study is expanded to include any person with HIV acquired in
infancy or young childhood who is older than 7 and meets other inclusion criteria.

Eligibility for cardiac sub-study will also include HIV uninfected subjects (18-30 years of
age) who will server as a control group.

Design:

Serial evaluations of pubertal development, bone mineralization, body composition and fat
distribution, hepatic, renal, and cardiac status, and behavioral, cognitive, and
academic/vocational outcome.

Findings may be shared with the multicenter Pediatric HIV/AIDS Cohort Study and lead to more
intensive, focused substudies.

Inclusion 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 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.

INCLUSION CRITERIA FOR CARDIAC IMAGING SUB-STUDY:

HIV positive participants

- Known HIV disease, documented or believed to have been acquired during the first
decade of life

- Age greater than 7 years old

HIV negative participants

- HIV negative, documented by a negative ELISA

- Age greater than or equal to 18 years old and less than or equal to 30 years old

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 cannot 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).

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

Clinically significant, systemic illness (serious infections or significant cardiac,
pulmonary, hepatic or other organ dysfunction) which in the judgement of the Principanl
Investigator (or designee) would compromise the patient's ability to tolerate this study

Some subjects may be excluded from cardiac CT but still eligible to enroll in the rest of
the study. Exclusion criteria for the cardiac CT component include:

- Age less than 18 years

- Use of metformin-containing products less than 24 hours prior to contrast
administration

- History of Multiple Myeloma

Some subjects may be excluded from receiving contrast but will have a non-contrast cardiac
CT. Exclusion from receiving contrast include:

- Cratinine value greater than 1.4 mg/dL

- History of significant allergic reaction to CT contrast agents

Some subjects may receive the cardiac CT but will be excluded from receiving beta-blocker.
Exclusion criteria for receiving beta-blocker include:

- Asthma

- Active bronchospasm

- Moderate or severe COPD

- 2nd or 3rd degree AV block

- Decompensated cardiac failure

- Allergy to beta blockers

- Systolic blood pressure less than 100 mm HG

- Resting heart rate at the time of scan less than 60 if regular and less than 65 if
irregular

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Rohan Hazra, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

070087

NCT ID:

NCT00924365

Start Date:

February 2007

Completion Date:

Related Keywords:

  • HIV Infections
  • Children
  • AIDS
  • Toxicity
  • Development
  • Puberty
  • HIV
  • Pediatrics
  • HIV Infections
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892