Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William Shearer, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00253695
First received: November 10, 2005
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

This study is a first step in approaching the gap existing between understanding sleep abnormalities, alterations in sleep-regulating cytokines and HIV-1 disease regulating cytokines, and abnormal higher cortical function.


Condition Intervention
Sleep
HIV Infections
Device: Wrist Actigraphy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Studies in HIV+ Older Children/Adolescents

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Association of cytokines, sleep patterns, and neurocognitive function in youth with HIV. [ Time Frame: 11/2005 - 02/2009 ] [ Designated as safety issue: No ]
    Observational study only


Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 90
Study Start Date: July 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Wrist Actigraphy
    Wrist actigraph will record participants' sleeping patterns.
Detailed Description:

BACKGROUND:

In the growing number of HIV infected youth and young adults, it is important to study the effects of HAART treatment on sleep patterns and related neurocognitive and psychosocial function.

DESIGN NARRATIVE (including primary and secondary outcomes):

Using validated sleep questionnaires and actigraphy measurements, overnight polysomnography (PSG, sleep study) will assess the degree of abnormal sleeping patterns and daytime sleepiness in HIV infected children and HIV uninfected children (control group).

The following peripheral blood levels will be measured over a 24-hour period, at multiple time points, in all participants: TNF-alphaRI and IL-6 (sleep-regulating cytokines); IFN-gamma and IL-12 (cytotoxic or TH1 cytokines); and IL-10 and IL-1RA (inflammatory or TH2 cytokines). This will help to determine the association between alterations in sleep-regulating cytokines and HIV disease progression (CD4+ T-cell count, HIV-1 RNA level).

Neurocognitive and neuropsychological tests will be performed on all participants to determine if there is an association between lack of normal sleeping habits, alterations in sleep-regulating cytokines and HIV-1 disease progression cytokines, and neurocognitive/neuropsychological performance.

Computer analysis of electroencephalography (EEG) will be performed during wakefulness and all stages of sleep to determine if greater disease severity, sleepiness, sleep disruption, and neurocognitive impairment is associated with increased amounts of slow activity. Improvement in these related factors will be associated with normalizations of these parameters. For some of these quantitative measures, the findings may be more significant for particular brain regions; for example, frontal regions in the case of attention problems.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

HIV-infected children with and without asthma.

Criteria

Inclusion Criteria:

HIV Group

  • HIV-1 infection

Control Group

  • Family members and friends of HIV-1 infected children

Exclusion Criteria:

HIV Group

  • Pregnancy

Control Group

  • Pregnancy
  • Asthma
  • Sleep apnea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253695

Locations
United States, Texas
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: William Shearer, MD, PhD Texas Children's Hospital/Baylor College of Medicine
  More Information

Publications:
Foster SB, Paul ME, Glaze DG, Reuben JM, Harris LL, Cohen EN, Lee B-N, Kozinetz CA, Schwarzwald HL, Kline MW, Jackson CD, Loeb AJ, Frerking PR, Brouwers PY, Shearer WT. Viremia is associated with sleep disturbances, neurocognitive disorders and cytokine dysregulation in pediatric HIV infection. J Allergy Clin Immunol 2007;119;S232.
Fletcher CV, DeVille JG, Samson PM , Moye, Jr. JH, Church JA, Spiegel HML, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JS, Shearer WT, for the Pediatric AIDS Clinical Trials Group Protocol 351 Study Group. Non-linear pharmacokinetics of high-dose recombinant fusion protein CD4-IgG2 (PRO542) observed in HIV-1-infected children. J Allergy Clin Immunol 2007;119:747-750.

Responsible Party: William Shearer, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00253695     History of Changes
Other Study ID Numbers: 1317, R01HL079533
Study First Received: November 10, 2005
Last Updated: March 26, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014