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Trial record 1 of 15 for:    12-I-0157
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Clinical Outcomes in Persons With HIV Acquired Early in Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01656564
First received: July 31, 2012
Last updated: November 11, 2014
Last verified: April 2014

July 31, 2012
November 11, 2014
July 2012
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To explore the clinical outcomes and the impact of HIV infection and antiretroviral therapy on a cohort with HIV infection acquired in early life. [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01656564 on ClinicalTrials.gov Archive Site
  • To evaluate the prevalence and the extent of cardiac abnormalities in this population compared to healthy controls using non-invasive MR and CT imaging [ Time Frame: Every 5 years ] [ Designated as safety issue: No ]
  • To identify long-term infectious and non-infectious complications of HIV and ART in this cohort [ Time Frame: Annually ]
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Clinical Outcomes in Persons With HIV Acquired Early in Life
Clinical Outcomes in Persons With HIV Acquired Early in Life

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 were infected with HIV before age 10.
  • 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.
  • Heart function tests and imaging studies, including ultrasound and echocardiograms, will be used to look more closely at the heart.
  • Treatment will not be provided as part of this study.

Background:

  • Antiretroviral therapy (ART) has altered the natural history of HIV disease in children.
  • Longterm 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 greater than 18 yrs of age who acquired HIV infection in early life.
  • Individuals previously enrolled in Protocol 07-C-0087 (A natural history study of HIV acquired in infancy or childhood) will be offered enrollment in this study.
  • Healthy volunteers without HIV (> 18 years of age) will serve as a control group.

Design:

- Annual evaluations of health status, immune function and other health parameters related to HIV infection will be conducted. In addition, a subset of participants will complete a detailed cardiac evaluation with imaging which may be repeated every 5 years.

Observational
Time Perspective: Prospective
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  • HIV
  • Childhood
  • Natural History
  • Cardiac
  • ART
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
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  • SUBJECT INCLUSION CRITERIA:

Previous enrollment in Protocol 07-C-0087, or

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, unless previously enrolled in Protocol 07-C-0087

Healthy volunteers

  • HIV negative, documented by a negative ELISA
  • Age greater than or equal to 18 years
  • Free of any major underlying medical disorder

For cardiac imaging sub-study:

Previous enrollment in Protocol 07-C-0087 or,

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

Healthy volunteers

  • HIV negative, verified by a negative ELISA
  • Age greater than or equal to 18

SUBJECT EXCLUSION CRITERIA:

-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 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 < 60 cc/min/1.73m(2).
  • Subjects with congenital cardiac disease history.

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

  • Age < 18 years
  • 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:

  • Creatinine value > 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 betablocker. 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 < 100 mmHg
  • Resting heart rate at the time of scan < 60 if regular and < 65 if irregular
Both
10 Years and older
Yes
Contact: Julia B Purdy, C.R.N.P. (301) 451-9109 purdyj@mail.nih.gov
United States
 
NCT01656564
120157, 12-I-0157
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP