HIV InfectionsNCT00000759
Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and neurological battery. Scaling of instruments to allow measurement of functions from infancy to early adulthood; establish reliability and validity of the new instruments developed for the NIMH Neurodevelopmental Battery. Read more about this study
- Who is it for?
- Ages 3 months to 8 years
- Conditions the study is for
- HIV Infections
- How many people
- 675 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 3 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must have:
- AS PER AMENDMENT 10/24/96:
- Signed, informed consent from a parent or legal guardian for patients under 18 years of age.
- HIV-Infected Group: Documentation of HIV infection from a state-licensed lab as follows: Children > one month of age:
- Documentation of current or prior enrollment in an investigational drug therapy or other research protocol in which the protocol inclusion criteria specify HIV infection OR laboratory evidence of vertically transmitted HIV infection as demonstrated on two separate peripheral blood samples by either a positive viral culture (blood or cerebrospinal fluid) OR detectably serum p24 antigen OR positive HIV-DNA PCR.
- Children >= 18 months of age:
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- Fulfillment of above criteria OR >= 2 positive tests for HIV antibody (two different specimens) determined by a federally-licensed test kit for detection of antibody, confirmed by an independent supplemental test.
- Documentation of presumption of maternal HIV infection at or prior to the birth of the child.
- HIV-Exposed, Uninfected Group: Children < 18 months of age:
- At least two negative tests for direct detection of HIV (viral culture and/or antigen detection and/or PCR assay and normal immunologic function.
- Children >= 18 months of age:
- Negative serological test by an FDA-licensed test kit for detection of HIV antibody performed on a specimen obtained at >= 18 months of age.
- Documentation of presence of maternal HIV infection at or prior to the birth of the child.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- AS PER AMENDMENT 10/24/96:
- Central nervous system (CNS) disorders including poorly controlled seizure disorder while on anticonvulsant therapy, evidence of neuroimaging abnormality resulting from a traumatic brain injury or major congenital malformations associated with CNS dysfunction.
- Genetic diseases including:
- inborn errors of metabolism, inherited genetic diseases that would compromise CNS function, chromosomal disorder that would compromise CNS function, cystic fibrosis, muscular dystrophy, sickle cell anemia.
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- Juvenile onset diabetes.
- Organ transplant recipients.
- Deafness or blindness.
- Concurrent Medication:
- Excluded:
- Intrathecal or intraventricular chemotherapy.
- Concurrent Treatment:
- Excluded:
- Cranial or spinal radiation therapy.
- Patients with the following prior conditions are excluded:
- Traumatic brain injury with loss of consciousness of > 24 hours and/or skull fracture.
- Prematurity including:
- intraventricular hemorrhage > grade 2, requirement for mechanical ventilation for > 28 days, seizures or another perinatal brain injury history including history of hydrocephaly.
- Prior Medication:
- Excluded:
- Intrathecal or intraventricular chemotherapy.
- Prior Treatment:
- Excluded:
- Cranial or spinal radiation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and neurological battery. Scaling of instruments to allow measurement of functions from infancy to early adulthood; establish reliability and validity of the new instruments developed for the NIMH Neurodevelopmental Battery. Downward extension of cognitive domains into infancy and early childhood. To describe and compare outcomes when assessing level of development versus rate of change. Describe and compare the outcomes from a global assessment of neurodevelopment (e.g., a standardized I.Q. score) versus discrete assessments (e.g., functional domains such as motor or language skills). Develop guidelines for multicultural neuropsychological and neurological assessment within a clinical trials design. Describe the nature of impaired developmental abilities and course of the disease in infants and children.
The assessment of children who sustain central nervous system (CNS) insult requires approaches that differ in several ways from adult-based assessment. The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development.
Read the detailed description
The assessment of children who sustain central nervous system (CNS) insult requires approaches that differ in several ways from adult-based assessment. The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development.
This study will be conducted as a nested substudy within ACTG 152. AS PER AMENDMENT 10/24/97: ACTG 188 was originally a nested study within ACTG 152, a three-arm clinical drug trial, but, due to recruitment limitations, expanded to include other protocol and non-protocol children with HIV-1 infection.
It will include 225 HIV-infected patients from ACTG 152, as well as an additional 450 non-infected participants recruited for two comparison groups, one consisting of seronegative infants and children with perinatal exposure to HIV and a second group without perinatal exposure to HIV. AS PER AMENDMENT 10/24/96: Patients in the HIV-unexposed and uninfected group are discontinued from the study and remaining patients are reassigned to two new age groups: 3 months to 41 months and 30 days or 42 months to 9 years, 11 months, 30 days. Patients 33 months or older but less than 42 months are discontinued from the study, those patients less than 33 months at the time of enrollment are graduated from the study at the age of 42 months.
A neurological assessment battery will evaluate the following domains: growth, sensory, tone, motor, posture, locomotion, hand use, deep tendon reflexes, abnormal movements, language, and behavior. Participants will be asked to do different kinds of activities such as talking, listening, and drawing, and to play games that involve walking, jumping, concentration, and memory. All participants will be assessed at clinic visits and followed for 72 weeks. AS PER AMENDMENT 10/23/97: A modified version of the neurological battery will be discontinued from interim follow-up evaluations and will be administered one last time as part of the exit evaluation.
- Conditions
- HIV Infections
- Keywords
- Central Nervous System Diseases, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases
- Medical subject headings
- HIV Infections, Central Nervous System Diseases, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- Observational model
- Natural history
- Enrolment
- 675 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Wilson B, Study chairFletcher J, Study chairBelman A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000759
- Sponsor's protocol ID
- ACTG 188
- Status last verified
- Jun 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
- ClinicalTrials.gov ID
- NCT00000759
- Acronym / sponsor ID
- ACTG 188
- Conditions
- HIV Infections
- Keywords
- Central Nervous System Diseases, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- First posted
- 31 Aug 2001 (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.
AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and neurological battery. Scaling of instruments to allow measurement of functions from infancy to early adulthood; establish reliability and validity of the new instruments developed for the NIMH Neurodevelopmental Battery. Downward extension of cognitive domains into infancy and early childhood. To describe and compare outcomes when assessing level of development versus rate of change. Describe and compare the outcomes from a global assessment of neurodevelopment (e.g., a standardized I.Q. score) versus discrete assessments (e.g., functional domains such as motor or language skills). Develop guidelines for multicultural neuropsychological and neurological assessment within a clinical trials design. Describe the nature of impaired developmental abilities and course of the disease in infants and children.
The assessment of children who sustain central nervous system (CNS) insult requires approaches that differ in several ways from adult-based assessment. The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development.
Detailed description
The assessment of children who sustain central nervous system (CNS) insult requires approaches that differ in several ways from adult-based assessment. The rapid changes that occur in the developing CNS as well as in behavior reflect underlying processes of growth and development.
This study will be conducted as a nested substudy within ACTG 152. AS PER AMENDMENT 10/24/97: ACTG 188 was originally a nested study within ACTG 152, a three-arm clinical drug trial, but, due to recruitment limitations, expanded to include other protocol and non-protocol children with HIV-1 infection.
It will include 225 HIV-infected patients from ACTG 152, as well as an additional 450 non-infected participants recruited for two comparison groups, one consisting of seronegative infants and children with perinatal exposure to HIV and a second group without perinatal exposure to HIV. AS PER AMENDMENT 10/24/96: Patients in the HIV-unexposed and uninfected group are discontinued from the study and remaining patients are reassigned to two new age groups: 3 months to 41 months and 30 days or 42 months to 9 years, 11 months, 30 days. Patients 33 months or older but less than 42 months are discontinued from the study, those patients less than 33 months at the time of enrollment are graduated from the study at the age of 42 months.
A neurological assessment battery will evaluate the following domains: growth, sensory, tone, motor, posture, locomotion, hand use, deep tendon reflexes, abnormal movements, language, and behavior. Participants will be asked to do different kinds of activities such as talking, listening, and drawing, and to play games that involve walking, jumping, concentration, and memory. All participants will be assessed at clinic visits and followed for 72 weeks. AS PER AMENDMENT 10/23/97: A modified version of the neurological battery will be discontinued from interim follow-up evaluations and will be administered one last time as part of the exit evaluation.
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 3 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Signed, informed consent from a parent or legal guardian for patients under 18 years of age.
- HIV-Infected Group: Documentation of HIV infection from a state-licensed lab as follows: Children > one month of age:
- Documentation of current or prior enrollment in an investigational drug therapy or other research protocol in which the protocol inclusion criteria specify HIV infection OR laboratory evidence of vertically transmitted HIV infection as demonstrated on two separate peripheral blood samples by either a positive viral culture (blood or cerebrospinal fluid) OR detectably serum p24 antigen OR positive HIV-DNA PCR.
- Fulfillment of above criteria OR >= 2 positive tests for HIV antibody (two different specimens) determined by a federally-licensed test kit for detection of antibody, confirmed by an independent supplemental test.
- Documentation of presumption of maternal HIV infection at or prior to the birth of the child.
Key exclusion criteria (25 listed)
- Central nervous system (CNS) disorders including poorly controlled seizure disorder while on anticonvulsant therapy, evidence of neuroimaging abnormality resulting from a traumatic brain injury or major congenital malformations associated with CNS dysfunction.
- Genetic diseases including:
- inborn errors of metabolism, inherited genetic diseases that would compromise CNS function, chromosomal disorder that would compromise CNS function, cystic fibrosis, muscular dystrophy, sickle cell anemia.
- Juvenile onset diabetes.
- Organ transplant recipients.
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 24 Jun 2005.
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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.
Wilson B study chair
Fletcher J study chair
Belman A study chair
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 Institute of Allergy and Infectious Diseases (NIAID) 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 13 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 24 Jun 2005. 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?
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 24 Jun 2005.