HIV study investigates link between virus and Body's daily rhythms
NCT ID NCT03133559
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how HIV might disrupt the body's internal clock, which could lead to health problems like diabetes and heart disease. Researchers will track gene activity at different times of day in 80 people with and without HIV. The goal is to understand why these issues are more common in people living with HIV.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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80 people
The number who actually took part.
- Started
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Apr 2017
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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25 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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