HIV InfectionsSAGNCT00503633
Biomarkers of Insomnia and Fatigue in HIV/AIDS (Symptoms and Genetics Study)
An observational study of HIV Infections, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with HIV
Who may be able to join
- HIV infection
- Access to a telephone
- Able to read and write English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- sleep disorders, genetics
- Medical subject headings
- HIV Infections, Sleep Wake Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startMar 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Kathryn A Lee, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503633
- Sponsor's protocol ID
- SAG
- Acronym
- SAG
- Status last verified
- Jun 2010
- First submitted
- 17 Jul 2007
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Insomnia and Fatigue in HIV/AIDS
- ClinicalTrials.gov ID
- NCT00503633
- Acronym / sponsor ID
- SAG / SAG
- Conditions
- HIV Infections
- Keywords
- sleep disorders, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify biological markers, including genes, associated with sleep disturbance and other symptoms among people with HIV.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with HIV
Key inclusion criteria (3 listed)
- HIV infection
- Access to a telephone
- Able to read and write English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn A Lee, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2010.