Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study) - Full Text View

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00503633

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

MedlinePlus related topics: AIDS Sleep Disorders

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

blood

Enrollment:	350
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2008

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 400 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:	University of California, San Francisco ( Kathryn A. Lee, PhD )
Study ID Numbers:	R01-MH074358
Study First Received:	July 17, 2007
Last Updated:	January 2, 2008
ClinicalTrials.gov Identifier:	NCT00503633 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by University of California, San Francisco:

sleep disorders
genetics

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Fatigue
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Sleep Disorders
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009