HIV Clinical Trial
— CHRONOSOfficial title:
Circadian HIV RNA Oscillations and Outcomes of Stress
NCT number | NCT02895087 |
Other study ID # | U19AI096109 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | January 2018 |
Verified date | October 2021 |
Source | University of Melbourne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Despite advances in AntiRetroviral Therapy (ART) leading to a rapid control of the HIV virus in individuals affected, HIV can persist indefinitely and there is no cure. The HIV virus has been shown to have a unique ability to hide within the human gene inside human cells and in tissues, remaining 'silent' and rapidly reactivate 'waking up" if ART is stopped. There are a number of ways to measure the silent HIV reservoir, including a common research-based laboratory test called Cell-Associated UnSpliced (CA-US) HIV RNA. This is an early marker of the HIV virus waking up. It is often used to test how well new drugs developed to eliminate the silent virus might work. This study is examining whether the diurnal variation (daily rhythm) and/or stress can affect CA-US HIV RNA levels in individuals diagnosed with HIV and receiving ART.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 25 Years to 55 Years |
Eligibility | Inclusion Criteria: - Male - HIV + - On suppressive ART > 3 years - Undetectable viral load, documented in past 3 months - English speaking - Have regular sleeping habits (~ 6 - 8 hours a night) [Cohort 1] - Do not do shift-work [Cohort 1] - Have not had any transcontinental travel in the last month [Cohort 1] Exclusion Criteria: - Known sleep disorder, Addison's disease, diabetes or thyroid/pituitary/adrenal/splenic disorder (note: corrected hypothyroid disorder may be allowed if recent Thyroid Stimulating Hormone (TSH) results are within normal limits); - Current cancer (radiation, chemo or surgery within past year); - Recent anemia - Medications that affect study outcomes, including Automatic Nervous System (ANS) measurement: Use of immunomodulation drugs (e.g. Interleukin 21, prednisone, growth hormone, tacrolimus, methotrexate; or other medications used in autoimmune disorders such as lupus, rheumatoid arthritis, Crohn's disease, MS) - Steroids including; corticosteroids (including regular use of inhaled/nasal steroids for severe/chronic asthma or allergies), testosterone, or anabolic steroids - Beta-blockers - Certain psychiatric medications including regular use of medium or long-acting benzodiazepines or other anxiolytics/sedatives (note: occasional use of short-acting anxiolytics or sleep meds okay); - Disulfiram or experimental Latent Retroviral Activation (LRA) use - Psychiatric conditions including current major depression or severe anxiety disorder; bipolar disorder; schizophrenia; current PTSD; or severe Attention Deficit Hyperactivity Disorder (ADHD) - Alcohol use > 14 drinks/week, or daily use of any recreational drug other than marijuana (participant must be able abstain from alcohol and recreational drug use the day before and day of study visits) - BMI>34.9 - Pacemaker - General anesthesia in the past month - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Division of Infectious Diseases | Milwaukee | Wisconsin |
United States | Osher Center, University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne | University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diurnal variation effects on HIV transcription | To determine if there are diurnal variations in cortisol and catecholamine in HIV transcription in latently-infected cells in HIV-infected participants on ART. | 24 hours | |
Primary | Stress Factor effects on HIV transcription | To determine the effects of stress-induced changes in cortisol and catecholamine on HIV transcription, in latently infected cells in HIV-infected participants on ART. | Baseline (visit 1) and visit 2 (approximately 1 - 7 days later) |
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