HivHCBNCT03133559
Mapping the Human HIV Chronobiome
An observational study of Hiv and Healthy, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Observational
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to Aug 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Being tested
- Observational
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients infected with HIV off antiretroviral therapy Receives: Other: Observational | |
| Cohort 2 | Patients infected with HIV experiencing virologic control, but with blunted immunologic recovery Receives: Other: Observational | |
| Cohort 3 | Matched healthy volunteers Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours
Secondary outcomes (2)
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).
Measured: 48 hours
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.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start19 Apr 2017
- Primary completionFeb 2028 (estimated)
- Study completionAug 2029 (estimated)
Why it stopped: Protocol Modification is pending
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Skarke, MD, University of Pennsylvania
- Investigators
- Carsten Skarke, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133559
- Sponsor's protocol ID
- 825626
- Acronym
- HCB
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2016
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: To be determined
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Human Immunodeficiency Virus Chronobiome, (HIV)
- ClinicalTrials.gov ID
- NCT03133559
- Acronym / sponsor ID
- HCB / 825626
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Protocol Modification is pending
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: ObservationalPatients infected with HIV off antiretroviral therapy |
| Cohort 2 | – | Other: ObservationalPatients infected with HIV experiencing virologic control, but with blunted immunologic recovery |
| Cohort 3 | – | Other: ObservationalMatched healthy volunteers |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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).;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalWe 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. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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)
2 secondary outcomes
Variance explained [R^2 values]
Time frame: 48 hours
Variance explained [R^2 values]
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. To be determined
Related trials for Hiv
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skarke, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Healthy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-of-day fluctuations in core clock gene expression (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.