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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT03846206
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years of age;
* To sign voluntary informed consent;
* Male or female patients with a negative pregnancy test before inclusion in the study;
* Proven HIV infection (with HIV-1 positive antibodies);
* Patient should be on stable treatment with cART for at least 1 year
* The mean of all CD4 measurements during the year prior to the initiation of cART should be equal to greater than 350 cells / mm3
* The number of CD4 + at the time of recruitment must be equal to or greater than 500 cells / mm3;
* HIV viral load should be undetectable at least 6 months prior to study inclusion, and less determinations (occasional blips above the undetectable level are allowed).
Exclusion Criteria:
* Acquired Immunodeficiency Syndrome.
* Active opportunistic diseases.
* Patients coinfected with HCV or HBV
* Coagulopathy
* Renal insufficiency (creatinine\> 1.5 mg / dL)
* Pregnancy or breastfeeding
* Inability to sign informed consent
* Active opportunistic infections, or any active infection or cancer within 30 days prior to the screening visit;
* Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gammaglobulins or chemotherapy within 90 days prior to the screening visit;
* Use of anticoagulant medication;
* Use of any type of experimental medication during the 90 days prior to study entry;
* Uncontrolled psychiatric disorder;
* Patients with uncontrolled active autoimmune diseases;
* Usual use of antibiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03846206
Study Brief:
Protocol Section:
NCT03846206