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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT06799650
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed HIV infection;
2. Antiretroviral naive;
3. HIV Viral load \> 1.000;
4. CD4+ T cell counts \>350 cells/mm3;
5. Body weight \> 50 Kg;
6. Signed informed consent form.
Exclusion Criteria:
1. BMI \< 18.5 kg/m2 at screening;
2. Coinfection with HBV (HBsAg +) or HCV;
3. Any significant acute illness within one week before the first visit.
4. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening;
5. Active malignancy or malignancy in follow-up.
6. Changes in safety tests: neutrophil count \< 1,000 u/L; Hb \< 9.0 gm/dl; platelet count \< 75,000 u/L; creatinine \> 1.5 mg/dl, direct bilirubin \> 85 μmol/L, AST or ALT \> 2.5 X UNL;
7. Potential allergy or hypersensitivity to the components of the Gammora® formulation.
8. Participation in another clinical trial within 12 months before screening.
9. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06799650
Study Brief:
Protocol Section:
NCT06799650