Trial record 13 of 22 for:    " July 04, 2007":" August 03, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00503633
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : June 23, 2010
Information provided by:
University of California, San Francisco

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

Condition or disease
HIV Infections

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.

Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Insomnia and Fatigue in HIV/AIDS
Study Start Date : March 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue HIV/AIDS

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with HIV

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00503633

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

Responsible Party: Kathryn A. Lee, PhD, University of California, San Francisco Identifier: NCT00503633     History of Changes
Other Study ID Numbers: SAG
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: June 23, 2010
Last Verified: June 2010

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Signs and Symptoms