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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
  Purpose

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


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Insomnia and Fatigue in HIV/AIDS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Biospecimen Retention:   Samples With DNA

blood


Enrollment: 350
Study Start Date: March 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with HIV

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503633

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Kathryn A Lee, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Kathryn A. Lee, PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00503633     History of Changes
Other Study ID Numbers: SAG
Study First Received: July 17, 2007
Last Updated: June 22, 2010
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
sleep disorders
genetics

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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

ClinicalTrials.gov processed this record on May 21, 2013