Sleep, HIV Disease Progression, and Function in HIV Infected Children and Adolescents - Full Text View

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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:

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

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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

William Shearer, MD, PhD

Texas Children's Hospital/Baylor College of Medicine

More Information

Publications:

Foster SB, Paul ME, Kozinetz CA, Macias CG, Shearer WT. Prevalence of asthma in children and young adults with HIV infection. J Allergy Clin Immunol. 2007 Mar;119(3):750-2. No abstract available.

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.

Alvarez JA, Scully RE, Miller TL, Armstrong FD, Constine LS, Friedman DL, Lipshultz SE. Long-term effects of treatments for childhood cancers. Curr Opin Pediatr. 2007 Feb;19(1):23-31.

Armstrong FD. Neurodevelopment and chronic illness: Mechanisms of disease and treatment. Ment Retard Dev Disabil Res Rev. 2006;12(3):168-73. Review.

Fisher SD, Miller TL, Lipshultz SE. Impact of HIV and highly active antiretroviral therapy on leukocyte adhesion molecules, arterial inflammation, dyslipidemia, and atherosclerosis. Atherosclerosis. 2006 Mar;185(1):1-11. Epub 2005 Nov 16. Review.

Kozinetz CA, Matusa R, Hacker CS. Biologic and social determinants of sequelae and long-term survival of pediatric HIV in Romania. Ann Epidemiol. 2006 Aug;16(8):593-9. Epub 2006 Jan 23.

Lewis DE, Gross KL, Diez MM, Martinez ML, Lukefahr HN, Kozinetz CA, Arduino RC. CD8 apoptosis may be a predictor of T cell number normalization after immune reconstitution in HIV. J Transl Med. 2007 Jan 30;5:9.

Macias CG, Caviness AC, Sockrider M, Brooks E, Kronfol R, Bartholomew LK, Abramson S, Shearer W. The effect of acute and chronic asthma severity on pediatric emergency department utilization. Pediatrics. 2006 Apr;117(4 Pt 2):S86-95.

Shearer WT, DeVille JG, Samson PM, Moye JH Jr, Fletcher CV, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Olson WC. Susceptibility of pediatric HIV-1 isolates to recombinant CD4-IgG2 (PRO 542) and humanized mAb to the chemokine receptor CCR5 (PRO 140). J Allergy Clin Immunol. 2006 Aug;118(2):518-21. Epub 2006 May 19. No abstract available.

Pacheco SE, McIntosh K, Lu M, Mofenson LM, Diaz C, Foca M, Frederick M, Handelsman E, Hayani K, Shearer WT; Women and Infants Transmission Study. Effect of perinatal antiretroviral drug exposure on hematologic values in HIV-uninfected children: An analysis of the women and infants transmission study. J Infect Dis. 2006 Oct 15;194(8):1089-97. Epub 2006 Sep 11.

Williamson MP, McCormick TG, Nance CL, Shearer WT. Epigallocatechin gallate, the main polyphenol in green tea, binds to the T-cell receptor, CD4: Potential for HIV-1 therapy. J Allergy Clin Immunol. 2006 Dec;118(6):1369-74. Epub 2006 Oct 13.

HIV Paediatric Prognostic Markers Collaborative Study. Predictive value of absolute CD4 cell count for disease progression in untreated HIV-1-infected children. AIDS. 2006 Jun 12;20(9):1289-94.

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 June 18, 2013