Mapping the Human HIV Chronobiome

Healthy Clinical Trial

Official title:

Mapping the Human Immunodeficiency Virus Chronobiome, (HIV)

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03133559
• Other study ID #: 825626
• Status: Suspended
• Start date: April 19, 2017
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hiv

Intervention

Other:
• Observational
We will use a deep phenotyping approach to collect multidimensional datasets from individuals infected with HIV compared to healthy controls to define circadian rhythm disruptions associated with HIV infection.

Locations

Country	Name	City	State
United States	Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-of-day fluctuations in core clock gene expression	Relative expression normalized to housekeeping genes (GAPDH, ACTB) plotted by time of day (morning, afternoon, evening, night with target times of 08:00, 14:00, 20:00, 02:00 +/- 1 hour)	48 hours
Secondary	Variance explained [R^2 values]	To evaluate the linear relationships between every pairwise combination of variables in the integrated dataset, the R^2, or coefficient of determination, will be calculated for each pair using linear regression. A heat map of the proportion of variance in each variable (e.g. mobility, light exposure, systolic blood pressure) explained by each other variable will then be constructed to allow an integrative exploration of these data. This approach allows to integrate multiple measurements with different units of measure. The measurements include communication (number of phone calls and text messages), mobility (miles traveled), light exposure, blood pressure, heart rate, heart rate variability, sleep/wake times, body core temperature, multiomics outputs (abundance of metabolites, proteins, microbiota) and markers of cellular and inflammatory function and disease state (HIV infection).	48 hours
Secondary	Variance explained [R^2 values]	To evaluate the linear relationships between every pairwise combination of variables in the integrated dataset, the R^2, or coefficient of determination, will be calculated for each pair using linear regression. A heat map of the proportion of variance in each variable (e.g. mobility, light exposure, systolic blood pressure) explained by each other variable will then be constructed to allow an integrative exploration of these data. This approach allows to integrate multiple measurements with different units of measure. The measurements include communication (number of phone calls and text messages), mobility (miles traveled), light exposure, and sleep/wake times.	up to 4 months