Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT03133559
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT03133559
Study Brief:
Protocol Section:
NCT03133559