Natural History Study of HIV Acquired in Infancy or Childhood
|First Received Date ICMJE||June 17, 2009|
|Last Updated Date||January 24, 2017|
|Start Date ICMJE||February 1, 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00924365 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Natural History Study of HIV Acquired in Infancy or Childhood|
|Official Title ICMJE||A Natural History Study of HIV Acquired in Infancy or Childhood|
-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.
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.
To explore the clinical features and impact of HIV infection and antiretroviral therapy in an HIV-infected pediatric cohort.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||April 22, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
HIV negative participants
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:
Some subjects may be excluded from receiving contrast but will have a non-contrast cardiac CT. Exclusion from receiving contrast include:
Some subjects may receive the cardiac CT but will be excluded from receiving beta-blocker. Exclusion criteria for receiving beta-blocker include:
|Ages||6 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00924365|
|Other Study ID Numbers ICMJE||070087
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 22, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP