Mapping the Human HIV Chronobiome (HCB)

February 23, 2026 updated by: Carsten Skarke, MD, University of Pennsylvania

Mapping the Human Immunodeficiency Virus Chronobiome, (HIV)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1
Patients infected with HIV off antiretroviral therapy
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.
Cohort 2
Patients infected with HIV experiencing virologic control, but with blunted immunologic recovery
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.
Cohort 3
Matched healthy volunteers
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-of-day fluctuations in core clock gene expression
Time Frame: 48 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variance explained [R^2 values]
Time Frame: 48 hours
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
Variance explained [R^2 values]
Time Frame: up to 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carsten Skarke, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 825626

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be determined

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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