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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02856269
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infection
* Age ≥18 years
* Zinc level ≤0.75 mg/L
* Receiving a stable antiretroviral regimen with no plans to change during study
* Documentation of an HIV-1 RNA level of ≤400 copies/mL
* No diarrhea or nausea/vomiting for the last month
Exclusion Criteria:
* Pregnancy/lactation
* Presence of inflammatory condition
* Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.
* Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs
* Known cardiovascular disease
* Uncontrolled diabetes
* Allergy or intolerance to zinc sulfate.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 2.5 x Upper limit of normal (ULN)
* Hemoglobin \< 9.0 g/dL
* glomerular filtration rate (GFR) \< 50 mL/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02856269
Study Brief:
Protocol Section:
NCT02856269