HIV InfectionsNCT00110331
Central Nervous System Disease in HIV-infected Children on HAART
An observational study of HIV Infections and Central Nervous System Diseases, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will examine how HIV affects the brain and nervous system, learning, and behavior in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on this treatment regimen develop significant… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Central Nervous System Diseases
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2005to 9 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Inability or unwillingness to provide informed consent for subjects greater than 18 years, and inability or unwillingness of one parent / legal guardian to provide consent for subjects less than 18 years.
- Clinically significant, unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator or Chairpersons would compromise the patient's ability to tolerate this study or is likely to interfere with the study procedures or results
- Lumbar Puncture Exclusion Criteria:
- Increased intracranial pressure (head imaging and neurologic examination to be performed prior to LP)
- Spinal cord lesion (to be screened by neurologic examination; spine imaging if clinically indicated)
- Platelet count less than 75,000/mm(3)
- Abnormal PT/PTT
- Focal suppuration at puncture site
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
This study will examine how HIV affects the brain and nervous system, learning, and behavior in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on this treatment regimen develop significant brain or nervous system problems, such as learning difficulties, attention problems, hyperactivity, and depression.
People who acquired HIV disease in the first decade of life and who have evidence of central nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease, major depression or psychosis) may be eligible for this study. Candidates are screened with a medical history, physical examination, neuropsychological testing and a CT scan of the head, if one has not been done within 12 months of entering the study.
Read more
Participants undergo the following tests and procedures:
- MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain images of the brain and detect changes in certain brain chemicals that may be affected by HIV infection. Both procedures are done at the same time. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 50 to 60 minutes, during which time the patient can communicate with the staff.
- Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to measure their memory, attention, language, problem-solving, academic, and motor skills and questionnaires to assess behavioral and emotional functioning, quality of life, and adherence to HIV medication. Parents are also asked to complete questionnaires assessing their child's behavioral and emotional functioning, quality of life, important life events, and adherence to HIV medication.
- Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. Some fluid is collected through the needle. Blood tests and a physical examination are done before the procedure to make sure it can be done as safely as possible. Patients may also be sedated to prevent any discomfort.
- Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years after the initial evaluation.
Some blood and spinal fluid samples from participants are stored for possible future studies related to HIV research
Read the detailed description
Background:
Highly active antiretroviral therapy (HAART) has altered the natural history of HIV disease in children.
A significant minority of HIV-infected children has evidence of ongoing CNS disease.
Specific markers for CNS disease, factors predictive of risk for neurological decline, and pathophysiologic mechanisms have not yet been identified in HIV-infected children.
Objective:
To explore the clinical features (neurological and psychiatric exams, neuropsychological evaluation, and neuroimaging), viral and neuroinflammatory factors, anatomic changes (brain MRI) and patterns of brain metabolites (1H-MRS) associated with HIV-related CNS disease in HIV-infected children in the HAART era.
Eligibility:
HIV disease acquired in the first decade of life.
Evidence of CNS disease (classification of encephalopathy or CNS compromise or diagnosis of ADHD, bipolar disease, major depression, or psychosis).
Design:
Serial neurologic and psychiatric examinations, neuropsychologic test, neuroimaging, and CSF sampling will be performed once a year for a total of 3 evaluations.
- Conditions
- HIV Infections, Central Nervous System Diseases
- Keywords
- Encephalopathy, Neuroimaging, Cognition, Neuroinflammation, Opportunistic Infections, HIV, Central Nervous System Disease, Bipolar Disorder, Attention Deficit Hyperactivity Disorder, ADHD, Major Depression, Psychosis
- Medical subject headings
- HIV Infections, Central Nervous System Diseases, Brain Diseases, Neuroinflammatory Diseases, Opportunistic Infections, Bipolar Disorder, Attention Deficit Disorder with Hyperactivity, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2005 (estimated)
- Study start3 May 2005
- Study completion9 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 21 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
- NCT00110331
- Sponsor's protocol ID
- 050150
- Other IDs
- 05-C-0150
- Status last verified
- 9 Sep 2014
- First submitted
- 5 May 2005
- Last updated
- 12 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 11794218Belman 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 3000281Tamula MA, Wolters PL, Walsek C, Zeichner S, Civitello L. Cognitive decline with immunologic and virologic stability in four children with human immunodeficiency virus disease. Pediatrics. 2003 Sep;112(3 Pt 1):679-84. doi: 10.1542/peds.112.3.679.
PubMed 12949303
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Nervous System Disease in HIV-infected Children on HAART
- ClinicalTrials.gov ID
- NCT00110331
- Acronym / sponsor ID
- 050150
- Conditions
- HIV Infections, Central Nervous System Diseases
- Keywords
- Encephalopathy, Neuroimaging, Cognition, Neuroinflammation, Opportunistic Infections, HIV, Central Nervous System Disease, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 3 May 2005
- Study completion
- 9 Sep 2014
- First posted
- 6 May 2005 (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.
This study will examine how HIV affects the brain and nervous system, learning, and behavior in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on this treatment regimen develop significant brain or nervous system problems, such as learning difficulties, attention problems, hyperactivity, and depression.
People who acquired HIV disease in the first decade of life and who have evidence of central nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease, major depression or psychosis) may be eligible for this study. Candidates are screened with a medical history, physical examination, neuropsychological testing and a CT scan of the head, if one has not been done within 12 months of entering the study.
Participants undergo the following tests and procedures:
- MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain images of the brain and detect changes in certain brain chemicals that may be affected by HIV infection. Both procedures are done at the same time. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 50 to 60 minutes, during which time the patient can communicate with the staff.
- Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to measure their memory, attention, language, problem-solving, academic, and motor skills and questionnaires to assess behavioral and emotional functioning, quality of life, and adherence to HIV medication. Parents are also asked to complete questionnaires assessing their child's behavioral and emotional functioning, quality of life, important life events, and adherence to HIV medication.
- Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the CSF circulates below the spinal cord. Some fluid is collected through the needle. Blood tests and a physical examination are done before the procedure to make sure it can be done as safely as possible. Patients may also be sedated to prevent any discomfort.
- Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years after the initial evaluation.
Some blood and spinal fluid samples from participants are stored for possible future studies related to HIV research
Detailed description
Background:
Highly active antiretroviral therapy (HAART) has altered the natural history of HIV disease in children.
A significant minority of HIV-infected children has evidence of ongoing CNS disease.
Specific markers for CNS disease, factors predictive of risk for neurological decline, and pathophysiologic mechanisms have not yet been identified in HIV-infected children.
Objective:
To explore the clinical features (neurological and psychiatric exams, neuropsychological evaluation, and neuroimaging), viral and neuroinflammatory factors, anatomic changes (brain MRI) and patterns of brain metabolites (1H-MRS) associated with HIV-related CNS disease in HIV-infected children in the HAART era.
Eligibility:
HIV disease acquired in the first decade of life.
Evidence of CNS disease (classification of encephalopathy or CNS compromise or diagnosis of ADHD, bipolar disease, major depression, or psychosis).
Design:
Serial neurologic and psychiatric examinations, neuropsychologic test, neuroimaging, and CSF sampling will be performed once a year for a total of 3 evaluations.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Inability or unwillingness to provide informed consent for subjects greater than 18 years, and inability or unwillingness of one parent / legal guardian to provide consent for subjects less than 18 years.
- Clinically significant, unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator or Chairpersons would compromise the patient's ability to tolerate this study or is likely to interfere with the study procedures or results
- Increased intracranial pressure (head imaging and neurologic examination to be performed prior to LP)
- Spinal cord lesion (to be screened by neurologic examination; spine imaging if clinically indicated)
- Platelet count less than 75,000/mm(3)
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 12 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 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.
- Background: PubMed 12949303Tamula MA, Wolters PL, Walsek C, Zeichner S, Civitello L. Cognitive decline with immunologic and virologic stability in four children with human immunodeficiency virus disease. Pediatrics. 2003 Sep;112(3 Pt 1):679-84. doi: 10.1542/peds.112.3.679.
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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 and Central Nervous System Diseases, 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 0 inclusion and 8 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 12 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 NCT00110331, which also lists 3 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 12 Dec 2019.