Clinical trial NCT03133559: Mapping the Human HIV Chronobiome
Official title: Mapping the Human Immunodeficiency Virus Chronobiome, (HIV)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hiv
Healthy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: patients infected with HIV off antiretroviral therapy;

Cohort 2: patients infected with HIV experiencing virologic control, but with blunted immunologic recovery;

Cohort 3: matched healthy volunteers.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time-of-day fluctuations in core clock gene expression
timeFrame: 48 hours
Secondary outcomes:
measure: Variance explained [R^2 values]
timeFrame: 48 hours
measure: Variance explained [R^2 values]
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Carsten Skarke, MD
role: PRINCIPAL_INVESTIGATOR
References: