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:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT02473367
Eligibility Criteria:
Inclusion Criteria:
* Is HIV positive
* Is on a stable raltegravir-containing (400 mg every 12hr) antiretroviral (ARV) regimen for at least 1 month prior to study entry, with no changes, including dose adjustments; and agrees to maintain their current ARV therapy throughout the study.
* Be male, or a non-pregnant and non-breast feeding female at least 18 years of age at the pre-trial (screening)
* Has a Body Mass Index (BMI) =\< 32 kg/m\^2
Exclusion Criteria:
* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases (excluding HIV)
* Has a history of gastric bypass surgery
* Has a history of cancer (malignancy)
* Has a history of chronic diarrhea within approximately 3 months prior to the pre-trial visit
* Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-trial visit
* Has participated in another investigational trial within 4 weeks prior to the pre-trial visit
* Is currently taking rifampin or atazanavir or is unable to refrain from the use of 1) any proton pump inhibitor from two weeks prior to the study through the completion of Period 4, and 2) any H2-blockers, over-the-counter antacids, calcium supplements or multivitamins from one week prior to the study through the completion of Period 4
* Consumes greater than 3 glasses of alcoholic beverages or distilled spirits per day
* Consumes greater than 6 servings of coffee, tea, cola, energy-drinks, or other caffeinated beverages per day
* Is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02473367
Study Brief:
Protocol Section:
NCT02473367