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

NCT ID: NCT00253695

Last Updated: 2013-03-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Sleep; HIV Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Wrist Actigraphy

Wrist actigraph will record participants' sleeping patterns.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

William Shearer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Shearer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Children's Hospital/Baylor College of Medicine

Locations

Texas Children's Hospital/Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 17336620 (View on PubMed)

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.

Reference Type: BACKGROUND

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. doi: 10.1097/MOP.0b013e328013c89e.

Reference Type: BACKGROUND

PMID: 17224658 (View on PubMed)

Armstrong FD. Neurodevelopment and chronic illness: Mechanisms of disease and treatment. Ment Retard Dev Disabil Res Rev. 2006;12(3):168-73. doi: 10.1002/mrdd.20114.

Reference Type: BACKGROUND

PMID: 17061286 (View on PubMed)

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. doi: 10.1016/j.atherosclerosis.2005.09.025. Epub 2005 Nov 16.

Reference Type: BACKGROUND

PMID: 16297390 (View on PubMed)

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. doi: 10.1016/j.annepidem.2005.11.012. Epub 2006 Jan 23.

Reference Type: BACKGROUND

PMID: 16431133 (View on PubMed)

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. doi: 10.1186/1479-5876-5-9.

Reference Type: BACKGROUND

PMID: 17263884 (View on PubMed)

Lipshultz SE, Fisher SD, Sharma T, Milton A, Miller TL. HIV-associated cardiovascular disease. Dialogues in Cardiology 2007, in press.

Reference Type: BACKGROUND

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. doi: 10.1542/peds.2005-2000F.

Reference Type: BACKGROUND

PMID: 16777836 (View on PubMed)

Mitchell CD, Armstrong FD, Goodman KW, Cava A. Disclosure of HIV status to an infected child: medical, psychological, ethical, and legal perspectives in an era of "super-vertical" transmission. J Clin Ethics. 2008 Spring;19(1):43-52. No abstract available.

Reference Type: BACKGROUND

PMID: 18552052 (View on PubMed)

Nathan PC, Patel SK, Dilley K, Goldsby R, Harvey J, Jacobsen C, Kadan-Lottick N, McKinley K, Millham AK, Moore I, Okcu MF, Woodman CL, Brouwers P, Armstrong FD; Children's Oncology Group Long-term Follow-up Guidelines Task Force on Neurocognitive/Behavioral Complications After Childhood Cancer. Guidelines for identification of, advocacy for, and intervention in neurocognitive problems in survivors of childhood cancer: a report from the Children's Oncology Group. Arch Pediatr Adolesc Med. 2007 Aug;161(8):798-806. doi: 10.1001/archpedi.161.8.798.

Reference Type: BACKGROUND

PMID: 17679663 (View on PubMed)

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. doi: 10.1016/j.jaci.2006.03.028. Epub 2006 May 19. No abstract available.

Reference Type: BACKGROUND

PMID: 16890780 (View on PubMed)

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. doi: 10.1086/507645. Epub 2006 Sep 11.

Reference Type: BACKGROUND

PMID: 16991083 (View on PubMed)

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. doi: 10.1016/j.jaci.2006.08.016. Epub 2006 Oct 13.

Reference Type: BACKGROUND

PMID: 17157668 (View on PubMed)

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. doi: 10.1097/01.aids.0000232237.20792.68.

Reference Type: BACKGROUND

PMID: 16816558 (View on PubMed)

Fletcher CV, DeVille JG, Samson PM, Moye JH Jr, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Shearer WT; Pediatric AIDS Clinical Trials Group, Protocol 351 Study Group. Nonlinear pharmacokinetics of high-dose recombinant fusion protein CD4-IgG2 (PRO 542) observed in HIV-1-infected children. J Allergy Clin Immunol. 2007 Mar;119(3):747-50. doi: 10.1016/j.jaci.2006.10.045. No abstract available.

Reference Type: BACKGROUND

PMID: 17336619 (View on PubMed)

Foster SB, Lu M, Glaze DG, Reuben JM, Harris LL, Cohen EN, Lee BN, Zhao E, Paul ME, Schwarzwald H, McMullen-Jackson C, Clark C, Armstrong FD, Brouwers PY, Miller TL, Colin AA, Scott GB, Shahzeidi S, Willen EJ, Asthana D, Lipshultz SE, Thompson BW, Shearer WT. Associations of cytokines, sleep patterns, and neurocognitive function in youth with HIV infection. Clin Immunol. 2012 Jul;144(1):13-23. doi: 10.1016/j.clim.2012.04.004. Epub 2012 May 2.

Reference Type: RESULT

PMID: 22659030 (View on PubMed)

Other Identifiers

R01HL079533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1317

Identifier Type: -

Identifier Source: org_study_id