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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT04549467
Eligibility Criteria:
Inclusion Criteria:
1. Subject should be antiretroviral naïve (defined as \<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection).
2. Age ≥ 18 years
3. Screening plasma HIV-1 RNA ≥1000 c/mL
4. CD4 cell count nadir: any value
5. Effective contraception for women of childbearing potential.
6. Informed consent form signed by patient and investigator
Exclusion Criteria:
1. History of suicide ideation, intention or action.
2. Evidence of HBV infection based on the results of testing at Screening\* for HBV surface antigen (HBsAg), HBV core antibody (anti-HBc), HBV surface antibody (antiHBs or HBsAb), and HBV DNA as follows: Subjects positive for HBsAg are excluded; Subjects negative for anti-HBs and HBsAg but positive for anti-HBc and positive for HBV DNA are excluded.
3. Anticipated need for any HCV therapy during the first 48 weeks of the study.
4. Acute symptomatic HIV Infection.
5. Any active Opportunistic Infection (category C, CDC 2014).
6. Current pregnancy or breastfeeding.
7. No effective contraception for the women of childbearing.
8. Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening period to verify a result.
9. ALT (Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct bilirubinemia).
10. Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice).
11. Creatinine clearance of \<50 mL/min/1.73 m2 (Cockroft-Gault method).
12. History or presence of allergy to the trial drugs or their components.
13. Severe hepatic insufficiency (Child Pugh Class C).
14. Any available historical resistance test result.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04549467
Study Brief:
Protocol Section:
NCT04549467