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:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01656564
First received: July 31, 2012
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.

Condition
HIV
Childhood
Natural History
Cardiac
ART

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Outcomes in Persons With HIV Acquired Early in Life

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: July 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656564

Contacts
Contact: Julia B Purdy, C.R.N.P. (301) 451-9109 purdyj@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01656564     History of Changes
Other Study ID Numbers: 120157, 12-I-0157
Study First Received: July 31, 2012
Last Updated: April 24, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
HIV
Pediatric
ART
Longitudinal
Outcomes

ClinicalTrials.gov processed this record on October 19, 2014