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Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study) (SAG)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00503633
First received: July 17, 2007
Last updated: June 22, 2010
Last verified: June 2010
History of Changes

July 17, 2007
June 22, 2010
March 2005
May 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00503633 on ClinicalTrials.gov Archive Site
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Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study)
Biomarkers of Insomnia and Fatigue in HIV/AIDS

The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.

This study will characterize insomnia subtypes and identify genetic markers and metabolic parameters associated with these subtypes. The results will be useful in later developing interventions to improve sleep, reduce fatigue, and thereby enhance the quality of life of HIV-infected persons.

A cross-sectional sample of 350 subjects will be recruited to describe relationships between biomarkers and insomnia subtypes. The initial assessment will include:

  • wearing a wrist actigraph for 72 hours
  • providing a fasting blood sample
  • measuring blood pressure, height, weight, neck, waist, hip, and thigh
  • completing questionnaires
  • urine screening

Depending on the results of the initial assessment, approximately 200 subjects will be followed every month by telephone to assess symptoms and every 3 to 6 months with study visits similar to the initial assessment. Findings from this longitudinal part of the study will characterize the development of insomnia, fatigue, and daytime sleepiness over time in patients living with HIV.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood
Non-Probability Sample

Adults with HIV
HIV Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infection
  • Access to a telephone
  • Able to read and write English

Exclusion Criteria:

  • Current use of illicit drugs
  • Currently pregnant or within the previous 3 months
  • Working nightshift
  • Diagnosis of sleep apnea, narcolepsy, restless legs syndrome, or periodic limb movements, dementia, or psychotic illness
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00503633
SAG
No
Kathryn A. Lee, PhD, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Kathryn A Lee, PhD University of California, San Francisco
University of California, San Francisco
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP