HIV InfectionsNCT00924365
Natural History Study of HIV Acquired in Infancy or Childhood
An observational study of HIV Infections, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 and development of these children. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2007to 22 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- HIV positive participants
- Known HIV disease, documented or believed to have been acquired during the first decade of life
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- 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
Who cannot join
- 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.
- 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.
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Natural History Study of HIV Acquired in Infancy or Childhood
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 and development of these children.
- Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships.
Read more
Objectives:
- To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young.
- To develop ways to improve the quality of life for these individuals.
Eligibility:
-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.
Design:
- Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following:
- Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat.
- Review of medical records and family history.
- Blood and urine tests, including pregnancy test in females who can bear children.
- DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body).
- Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities.
- Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function.
- Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar
Read the 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 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.
- Conditions
- HIV Infections
- Keywords
- Children, AIDS, Toxicity, Development, Puberty, HIV, Pediatrics, HIV Infections
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start1 Feb 2007
- Study completion22 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Rohan Hazra, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924365
- Sponsor's protocol ID
- 070087
- Other IDs
- 07-C-0087
- Status last verified
- 22 Apr 2014
- First submitted
- 17 Jun 2009
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
PubMed 11794218Abrams EJ, Weedon J, Bertolli J, Bornschlegel K, Cervia J, Mendez H, Lambert G, Singh T, Thomas P; New York City Pediatric Surveillance of Disease Consortium. Centers for Disease Control and Prevention. Aging cohort of perinatally human immunodeficiency virus-infected children in New York City. New York City Pediatric Surveillance of Disease Consortium. Pediatr Infect Dis J. 2001 May;20(5):511-7. doi: 10.1097/00006454-200105000-00008.
PubMed 11368109Belman AL, Ultmann MH, Horoupian D, Novick B, Spiro AJ, Rubinstein A, Kurtzberg D, Cone-Wesson B. Neurological complications in infants and children with acquired immune deficiency syndrome. Ann Neurol. 1985 Nov;18(5):560-6. doi: 10.1002/ana.410180509.
PubMed 3000281Unsal AB, Mattingly AS, Jones SE, Purdy JB, Reynolds JC, Kopp JB, Hazra R, Hadigan CM. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2896-2904. doi: 10.1210/jc.2017-00197.
PubMed 28531309Mattingly AS, Unsal AB, Purdy JB, Gharib AM, Rupert A, Kovacs JA, McAreavey D, Hazra R, Abd-Elmoniem KZ, Hadigan C. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults. Pediatr Infect Dis J. 2017 Jan;36(1):63-65. doi: 10.1097/INF.0000000000001354.
PubMed 27749650
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Natural History Study of HIV Acquired in Infancy or Childhood
- ClinicalTrials.gov ID
- NCT00924365
- Acronym / sponsor ID
- 070087
- Conditions
- HIV Infections
- Keywords
- Children, AIDS, Toxicity, Development, Puberty, HIV, Pediatrics, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Feb 2007
- Study completion
- 22 Apr 2014
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and development of these children.
- Because of their disease, many children with HIV face additional difficulties with their health, well-being and development, such as success in school and peer relationships.
Objectives:
- To better understand how HIV infection and the medicines used to treat it affect the growth and development of children, adolescents and young adults who have been infected since birth or when they were very young.
- To develop ways to improve the quality of life for these individuals.
Eligibility:
-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.
Design:
- Periodic evaluation of pubertal development; bone mineralization; body composition and fat distribution; liver, kidney and heart status; and behavioral, cognitive and academic or vocational outcome of the study group. Evaluations include the following:
- Physical examinations, including height and weight measurements and skin-fold thickness testing to measure body fat.
- Review of medical records and family history.
- Blood and urine tests, including pregnancy test in females who can bear children.
- DEXA scans (X-ray test to measure bone strength and how much fat, muscle and bone is in the body).
- Neuropsychological testing, including evaluation of language, thinking and problem-solving abilities.
- Magnetic resonance imaging (MRI): Test using a magnetic field and radio waves to examine brain structure and function.
- Oral glucose tolerance test: Blood sampling before and one time after the subject drinks a sugary solution to measure the body's ability to use sugar
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 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.
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- HIV positive participants
Key exclusion criteria (25 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 11794218Gortmaker SL, Hughes M, Cervia J, Brady M, Johnson GM, Seage GR 3rd, Song LY, Dankner WM, Oleske JM; Pediatric AIDS Clinical Trials Group Protocol 219 Team. Effect of combination therapy including protease inhibitors on mortality among children and adolescents infected with HIV-1. N Engl J Med. 2001 Nov 22;345(21):1522-8. doi: 10.1056/NEJMoa011157.
- Background: PubMed 11368109Abrams EJ, Weedon J, Bertolli J, Bornschlegel K, Cervia J, Mendez H, Lambert G, Singh T, Thomas P; New York City Pediatric Surveillance of Disease Consortium. Centers for Disease Control and Prevention. Aging cohort of perinatally human immunodeficiency virus-infected children in New York City. New York City Pediatric Surveillance of Disease Consortium. Pediatr Infect Dis J. 2001 May;20(5):511-7. doi: 10.1097/00006454-200105000-00008.
- Background: PubMed 3000281Belman AL, Ultmann MH, Horoupian D, Novick B, Spiro AJ, Rubinstein A, Kurtzberg D, Cone-Wesson B. Neurological complications in infants and children with acquired immune deficiency syndrome. Ann Neurol. 1985 Nov;18(5):560-6. doi: 10.1002/ana.410180509.
- Derived from this study: PubMed 28531309Unsal AB, Mattingly AS, Jones SE, Purdy JB, Reynolds JC, Kopp JB, Hazra R, Hadigan CM. Effect of Antiretroviral Therapy on Bone and Renal Health in Young Adults Infected With HIV in Early Life. J Clin Endocrinol Metab. 2017 Aug 1;102(8):2896-2904. doi: 10.1210/jc.2017-00197.
- Derived from this study: PubMed 27749650Mattingly AS, Unsal AB, Purdy JB, Gharib AM, Rupert A, Kovacs JA, McAreavey D, Hazra R, Abd-Elmoniem KZ, Hadigan C. T-cell Activation and E-selectin Are Associated With Coronary Plaque in HIV-infected Young Adults. Pediatr Infect Dis J. 2017 Jan;36(1):63-65. doi: 10.1097/INF.0000000000001354.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Hazra, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924365, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.