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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT02362503
Eligibility Criteria:
Inclusion Criteria:
* Men and non-pregnant women with chronic HIV-1 infection
* Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
* Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
* Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
* Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
* Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort
Exclusion Criteria:
* Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
* HIV-2 infection
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 7 x ULN
* Alkaline Phosphatase \> 5 x ULN
* Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02362503
Study Brief:
Protocol Section:
NCT02362503