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 @ 5:12 AM
Ignite Modification Date:
2025-12-25 @ 5:12 AM
NCT ID:
NCT02146027
Eligibility Criteria:
Inclusion Criteria:
* Male or female HIV-1 infected patients aged between 18 and 60 years.
* Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
* No change in antiretroviral therapy in the last six months or intended change in the next 12 weeks.
* Availability for the study procedures during the study period.
* Giving informed consent to participate in the study
Exclusion Criteria:
* Diagnosis of any concomitant infections or diseases that might affect immunity or natural history of HIV-1 infection including active Hepatitis B infection, Hepatitis C infection, diabetes mellitus, neoplasias and autoimmune diseases.
* Use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents.
* History of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc.
* Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).
* Unable to safely store the study product at home in the conditions recommended by the manufacturer.
* Any other condition that might interfere with the study procedure according to the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02146027
Study Brief:
Protocol Section:
NCT02146027