NCT00001448

Brief Summary

The main objectives of this study are: 1) to determine whether various levels of severity of oral candidiasis (thrush) in the child are associated with different levels of speech production, feeding skills, and self-concept, and 2) to assess the effect of the reduction of oral thrush over time on the speech function, feeding skills, and self-concept in HIV-infected patients who already are receiving various antifungal medications for treatment of their thrush (Note: Decisions regarding antifungal therapy are made completely independent from this study). Children with HIV disease, ages 6-21 years, who have oral thrush are eligible to paricipate in the study. The child and his/her parent will be asked to complete a variety of measures at specific time intervals over approximately one month during visits to the National Institutes of Health for treatment on other protocols. First, a nurse will rate the location and severity of thrush in the child's mouth. Then the parent will complete questionnaires assessing the effect of oral thrush on the child's feeding and speech skills and everyday functioning. Finally, the child will be administered a brief speech and oral-motor evaluation and will complete some questionnaires about how the thrush affects his/her day-to-day activities and self-concept. The results of this study may help to better understand the cause of expressive language deficits observed in some children with HIV infection. More specifically, it will determine if any speech and feeding problems of HIV-infected children are associated with oral thrush. Learning more about the impact of oral thrush on the speech, feeding, and the self-concept of children with HIV disease may be used for parent and patient education and to develop rehabilitative recommendations to benefit HIV-infected patients with oral thrush.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

July 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Antifungal TherapyArticulationBehaviorExpressive LanguageThrush

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Children and adolescents with HIV infection, ages 6 through 21 years of age, who are treated in other protocols at the Pediatric Branch of the National Cancer Institute (NCI) and have oral candidiasis as determined by the Pediatric Nurse Practitioners, are eligible to participate in this study. Children and adolescents with infections or diseases other than candidiasis affecting the oral cavity as determined by the PNP's during the physical exam will be excluded from the study. Furthermore, patients who are identified by the speech pathologist to have oro-facial structural and/or functional abnormalities that cause a significant disturbance in speech, voice, or swallowing will be excluded. Children will also not be able t participate in the study if they cannot understand the measures, even if the questions are read to them, which will be determined by the Neuropsychology staff.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Epstein LG, Sharer LR, Oleske JM, Connor EM, Goudsmit J, Bagdon L, Robert-Guroff M, Koenigsberger MR. Neurologic manifestations of human immunodeficiency virus infection in children. Pediatrics. 1986 Oct;78(4):678-87.

    PMID: 2429248BACKGROUND
  • Pressman H. Communication disorders and dysphagia in pediatric AIDS. ASHA. 1992 Jan;34(1):45-7. No abstract available.

    PMID: 1540256BACKGROUND
  • Wolters PL, Brouwers P, Moss HA, Pizzo PA. Differential receptive and expressive language functioning of children with symptomatic HIV disease and relation to CT scan brain abnormalities. Pediatrics. 1995 Jan;95(1):112-9.

    PMID: 7770287BACKGROUND

MeSH Terms

Conditions

Candidiasis, OralFeeding and Eating DisordersHIV InfectionsSpeech DisordersBehavior

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsMouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

August 1, 1995

Study Completion

June 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-07

Locations