Study to Explore Natural Daily Variation and Impact of Stress in HIV Levels
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 25 - 55 |
| Updated: | 3/29/2019 |
| Start Date: | March 2015 |
| End Date: | December 2019 |
Circadian HIV RNA Oscillations and Outcomes of Stress
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.
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.
Undetectable or low circulating levels of HIV virus in blood are the result of people who
have been diagnosed with a HIV-infection and who have adhered to a HIV AntiRetroviral Therapy
(ART) regimen. However, the ART has not eradicated the virus from the body and individuals
who cease ART can rapidly revert from a well-controlled state to showing high levels of HIV
virus in the blood. 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 [or
wake up] if ART is stopped. Efforts are underway to explore novel ways to entirely eradicate
HIV from individuals, so that people who are HIV-infected can stop treatment and still have
undetectable HIV viral load and remain well despite not being on HIV treatment.
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 reactivating. It is often used to test how well new drugs
developed to eliminate the silent virus might work.
Recently as investigators involved in another clinical study, an unexpected observation was
noted in a group of HIV study participants on ART between the CA-US HIV RNA levels and time
of blood collection. Levels of CA-US HIV RNA appeared to be lower when blood samples were
collected earlier in the morning. However, at the time of this observation, as investigators
were unable to establish whether this discrepancy could be due to (i) the diurnal variation
or (ii) unknown stress factors that may have been experienced by the study participants. It
has previously been demonstrated that individuals with untreated HIV infection there is a
variation in HIV RNA levels and the time of day. However, the effects of external factors
such as time of day or stresses on CA-US HIV RNA levels in individuals while on ART have not
been previously examined.
This study hopes to explore and answer the questions (i) Does the diurnal variation play a
role in regulating the levels of CA-US HIV RNA in blood of individuals diagnosed with HIV and
receiving ART and (ii) Does stress affect the levels of CA-US HIV RNA.
Understanding some factors that affect levels of CA-US HIV RNA may provide a new perspective
on ways to eliminate the silent virus.
have been diagnosed with a HIV-infection and who have adhered to a HIV AntiRetroviral Therapy
(ART) regimen. However, the ART has not eradicated the virus from the body and individuals
who cease ART can rapidly revert from a well-controlled state to showing high levels of HIV
virus in the blood. 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 [or
wake up] if ART is stopped. Efforts are underway to explore novel ways to entirely eradicate
HIV from individuals, so that people who are HIV-infected can stop treatment and still have
undetectable HIV viral load and remain well despite not being on HIV treatment.
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 reactivating. It is often used to test how well new drugs
developed to eliminate the silent virus might work.
Recently as investigators involved in another clinical study, an unexpected observation was
noted in a group of HIV study participants on ART between the CA-US HIV RNA levels and time
of blood collection. Levels of CA-US HIV RNA appeared to be lower when blood samples were
collected earlier in the morning. However, at the time of this observation, as investigators
were unable to establish whether this discrepancy could be due to (i) the diurnal variation
or (ii) unknown stress factors that may have been experienced by the study participants. It
has previously been demonstrated that individuals with untreated HIV infection there is a
variation in HIV RNA levels and the time of day. However, the effects of external factors
such as time of day or stresses on CA-US HIV RNA levels in individuals while on ART have not
been previously examined.
This study hopes to explore and answer the questions (i) Does the diurnal variation play a
role in regulating the levels of CA-US HIV RNA in blood of individuals diagnosed with HIV and
receiving ART and (ii) Does stress affect the levels of CA-US HIV RNA.
Understanding some factors that affect levels of CA-US HIV RNA may provide a new perspective
on ways to eliminate the silent virus.
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
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