Study to Explore Natural Daily Variation and Impact of Stress in HIV Levels
Completed
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT02895087
- Run by
- University of Melbourne
- People needed
- 40
- Starts
- 2015-03-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 25 and older, up to 55. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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]
You may not qualify if…
- 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
Where it is running
- Osher Center, University of California San Francisco — San Francisco, California, United States
- Division of Infectious Diseases — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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