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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT02131233
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 positive
* Naïve to antiretroviral therapy including investigational antiretroviral agents
* Not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study
Exclusion Criteria:
* Use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence
* Has been treated for a viral infection other than HIV-1 (such as hepatitis B) with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine
* Has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir before the first dose of study drug
* Has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study
* Has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed)
* Requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as TUMS™, Maalox™ and Milk of Magnesia™
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs
* Has current, active diagnosis of acute hepatitis due to any cause
* Is pregnant, breastfeeding, or expecting to conceive during the study
* Female participant expecting to donate eggs or male participant expecting to donate sperm during the study
* Is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02131233
Study Brief:
Protocol Section:
NCT02131233