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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT05872659
Eligibility Criteria:
Inclusion Criteria:
* Confirmed HIV infection.
* ≥18 years old, gender unlimited.
* ≥12 months of continuous antiviral therapy and at least 2 viral loads (3 months or more apart) \< 50 Copies/mL at screening.
* The antiviral regimen was not changed in the 12 months prior to enrollment.
* CD4+T lymphocyte count \< 200 μL-1 in patients receiving antiviral therapy for more than 1 year and less than 2 years or \< 350 μL-1 in patients receiving antiviral therapy for ≥ 2 years.
* Understand and sign the informed consent.
Exclusion Criteria:
* Infection with other viruses: HBV-DNA positive, HCV RNA positive, anti-Hav IgM, anti-HDV IgM and anti-HEV IgM positive and ALT \>80 IU/L, anti-TP positive.
* Active and uncontrollable infection.
* Malignant tumor or tumor history.
* Complicated with abnormal function of heart, liver, lung, kidney and other major organs.
* When the laboratory test satisfies any item (WBC \< 3.5\*10\^9/L; PLT \< 80\*10\^9/L; HGB \< 100 g/L).
* Drug dependent.
* Pregnant and lactating women.
* Severe allergic constitution, or known allergy to the study drug and its components;
* Accepting immunosuppressants or other immunomodulators (including thymosin) or systemic cytotoxic agents within 6 months prior to screening.
* Participated in other clinical studies within 3 months prior to this study.
* patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05872659
Study Brief:
Protocol Section:
NCT05872659