Mapping the Human HIV Chronobiome

NCT ID: NCT03133559

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2029-08-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

Patients infected with HIV off antiretroviral therapy

Observational

Intervention Type: 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 2

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

Observational

Intervention Type: 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 3

Matched healthy volunteers

Observational

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Carsten Skarke, MD

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carsten Skarke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

825626

Identifier Type: -

Identifier Source: org_study_id