Completed

Assessment of Attentional Functioning in Children With HIV-1 Infection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: December 1995
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1995

Actual date on which the first participant was enrolled.

Children with symptomatic HIV-1 (Human Immunodeficiency Virus) infection are at increased risk for developing severely disabling neurological and neuropsychological deficits. HIV-1 related CNS (Central Nervous System) disease is a clinical syndrome, manifested by varying and sometimes discordant degrees of cognitive, motor and behavioral impairment. A continuum of clinical presentations attributed to the effects of HIV-1 infection on the CNS, ranging from apparently normal development, decreases in the rate of new learning to the loss of acquired skills have been observed. Two domains of psychological functioning appear most susceptible to the effects of HIV infection on the central nervous system in children: expressive behavior and attentional processes (Brouwers, et al, 1994). Attention deficits have been documented as a relative weakness on the "freedom from distractibility" subclass of IQ tests (Brouwers et al, 1989) and on behavior assessment (Moss et al, 1994). Attention, however, has many subcomponents such as focused attention, divided attention, vigilance, etc. Direct assessment of attentional functioning using reaction time has not yet been conducted and questions whether attentional components are differentially affected by the virus have not been addressed. The proposed study would assess different components of attentional functioning in children with HIV-1 disease. A quantitative and systematic method is developed that could complement the existing standardized instruments used for measuring attention and neurocognitive function in this population. Simple alerted visual reaction time will be measured with varying preparatory intervals, a two-choice reaction time in a go/no-go paradigm will be administered, and a continuous performance, divided reaction time test and an object decision task will be given. Performance on these measures will also be related to measures of brain structure and stage of HIV-1 disease.

NCT00001497
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesMental DisordersCentral Nervous System DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesNeurologic ManifestationsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAttention Deficit and Disruptive Behavior DisordersNeuromuscular ManifestationsNeurodevelopmental DisordersAttention Deficit Disorder with HyperactivityBrain DiseasesParalysisSpasmHIV Infections

Criteria

Children and adolescents with HIV infection ages 5-18. Have to be on another treatment protocol at the Division of Clinical Sciences, NCI. No children with non-HIV associated CNS compromise, such as for example resulting from head trauma, or genetic factors. No children with uncorrectable (20/20) vision.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Cancer Institute (NCI)

Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps
CompletedOne Study Center