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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT00148759
Eligibility Criteria:
Inclusion Criteria:
* Age greater or equal to 18 years
* Diagnosis of HIV infection as previously established by HIV Enzyme-Linked Immunosorbent Assay (ELISA) test and confirmed by Western blot analysis.
* Must have been taking LPV/r as part of an antiretroviral regimen at a dose of 400/100 mg orally twice per day for at least 3 months.
* Recent (within last 90 days) HIV-RNA copies must be less than 400 copies/ml
Exclusion Criteria:
* Hepatic abnormality: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST) or total bilirubin (TBR) ≥ 3 x upper limit of normal
* Renal insufficiency: serum creatinine ≥ 2 mg/dl
* Co-infection with hepatitis B and/or C viruses
* Pregnant or breastfeeding
* Use of concurrent medications known to affect lopinavir or ritonavir concentrations significantly.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00148759
Study Brief:
Protocol Section:
NCT00148759