Mapping the Human HIV Chronobiome

NCT03133559 | Suspended

• 1 other identifier: 825626
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Variance explained [R^2 values]

  48 hours

• Variance explained [R^2 values]

  up to 4 months

Study Arms (3)

Cohort 1

Patients infected with HIV off antiretroviral therapy

Other: Observational

Cohort 2

Patients infected with HIV experiencing virologic control, but with blunted immunologic recovery

Other: Observational

Cohort 3

Matched healthy volunteers

Other: Observational

Interventions

Observational OTHER

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 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen = None for Cohort 1. Completed Cohort 1.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Carsten Skarke, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: April 28, 2017
• Study Start: April 19, 2017
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)