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 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT04863066
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 to 70 years
2. HIV-1 infection by confirmed test;
3. Receiving antiviral treatment ≥ 1 years;
4. Current CD4+ T cell count \> 350 cells/μl;
5. HIV-1 RNA levels of \< 50 copies/ml for at least a year;
6. Patients who agrees to use two effective methods of contraception to avoid pregnancy during the study period.
7. Patients who sign the informed consent form prior to inclusion in the study.
Exclusion Criteria:
1. Patients with concomitant HAV, HBV, HCV, HDV, HEV, EBV, CMV or syphilis infection;
2. A history of AIDS-related opportunistic infections and tumors within 1 year prior to enrollment;
3. A History of corticosteroids or immunosuppressive drugs for autoimmune diseases by physicians within the last 2 years;
4. Participants with clinically significant laboratory abnormalities as follows:
* Hemoglobin ≤ 10 gm/dl (female), \<11g/dl (male)
* Absolute neutrophil count ≤ 1×10\^9/L
* Platelet count ≤100×10\^9/L
* Alanine aminotransferase (ALT)≥ 2.5 x ULN
* Aspartate aminotransferase (AST) ≥ 2.5 x ULN
* Total bilirubin \> 1.5 ULN
* Serum creatinine \>110 μmol/L
* International normalized ratio (INR) \>1.5 or activated partial thromboplastin time (APTT) \>45 s
5. Patients with severe psychiatric illness, drugs or alcohol abuse;
6. A woman who is in pregnancy or lactation;
7. A history of central nervous system disease, such as cerebral hemorrhage, dementia, epilepsy and autoimmune diseases;
8. Patients with a non-AIDS-related serious underlying disease;
9. Patients who participate in another clinical study currently which may affect the results of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04863066
Study Brief:
Protocol Section:
NCT04863066