Mapping the Human HIV Chronobiome



Status:Active, not recruiting
Conditions:Healthy Studies, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:25 - 50
Updated:2/14/2019
Start Date:April 19, 2017
End Date:August 2021

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Individuals infected with HIV have a high risk of developing metabolic comorbidities not
traditionally associated with the immune dysregulation and deficiency associated with HIV
infection and AIDS. Many of these comorbidities in HIV uninfected individuals have been
linked to a disordered circadian clock function. The study investigators will further
evaluate the circadian clock in HIV infection as a mechanism underlying the metabolic
dysregulation in this population.


Inclusion Criteria:

- Cohort 1: Diagnosis of HIV infection with CD4+ counts <500 cells/mm3 while untreated;

- Cohort 2: Diagnosis of HIV infection with CD4+ counts <300 cells/mm3 on ARV;

- Cohort 3: Volunteers must be in good health as based on medical history, physical
examination, vital signs, and laboratory tests as deemed by PI;

- Volunteers are capable of giving informed consent;

- 25-50 years of age;

- Own a smartphone which installs the remote sensing applications;

- Non-smoking;

- Male subjects only if feasible during recruitment; and

- In case female volunteers are invited to enroll: non-pregnant, female subjects must
consent to a urine pregnancy test.

- Females of child bearing potential will be asked to use a medically accepted method of
birth control (such as oral contraceptives, intra-uterine device (IUD), or condom with
spermicide) while you participate in the study.

- The use of contraception will NOT be required for male participants.

Exclusion Criteria:

- Recent travel across more than two (2) time zones (within the past month);

- Planned travel across more than two (2) time zones during the planned study
activities;

- Volunteers with irregular work hours, e.g. night shifts or becoming a parent;

- Use of illicit drugs;

- High dose vitamins (Vitamin A, Vitamin C, Vitamin E, Beta Carotene, Folic Acid and
Selenium), alcohol and any over-the counter NSAID in the (2) two weeks before the
start of the 48 hour deep phenotyping period (Females who are taking birth control
pills can continue so for the duration of this study).;

- History of abdominal surgery;

- Subjects, who have received an experimental drug, used an experimental medical device
within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8
weeks prior to screening;

- Subjects with any abnormal laboratory value or physical finding that according to the
investigator may interfere with interpretation of the study results, be indicative of
an underlying disease state, or compromise the safety of a potential subject.

- Women who are breastfeeding.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Carsten Skarke, M.D.
Phone: 215-662-4652
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mi
from
Philadelphia, PA
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