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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT04144335
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection
* On continuous antiretroviral therapy for \> 12 months without any interruptions of greater than 14 consecutive days in the last 12 months
* Screening plasma HIV RNA levels \< 20 copies/mL on all available determinations in past 12 months (isolated single values ≥ 20 but \< 200 copies/mL will be allowed if they were preceded and followed by viral load determinations \< 20 copies/mL)
* Screening CD4+ T-cell count ≥ 400 cells/mm3
Exclusion Criteria:
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* Active or recent malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months; minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary
* Chronic liver disease defined as Class B and C on the Child-Pugh scale
* Active and poorly controlled atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following: (a) acute myocardial infarction, (b) acute coronary syndromes, (c) stable or unstable angina, (d) coronary or other arterial revascularization, (e) stroke, (f) transient ischemic attack (TIA), or (g) peripheral arterial disease grade IIa or greater
* History of AIDS-defining illness within the past 5 years
* History of potential immune-mediated medical conditions requiring concomitant treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment
* Exposure to any experimental therapies within 90 days of study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04144335
Study Brief:
Protocol Section:
NCT04144335