Status:
COMPLETED
Natural History Study of HIV Acquired in Infancy or Childhood
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HIV Infections
Eligibility:
All Genders
6+ years
Brief 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 ...
Detailed Description
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 understan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 22 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00924365
Start Date
February 1 2007
End Date
April 22 2014
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892