N/A
Completed N=33
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
Source: ClinicalTrials.gov NCT01153269 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters — 64; 69 U/liter
Summary
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters |
52; 53 | — |
| PRIMARY Viral Load |
1.5 | — |
| PRIMARY CD4 Cell Count |
525 | — |
Eligibility Criteria
Inclusion Criteria
- Patients infected by HIV-1 and HBV or HCV
- Age ≥18 years
- Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen
Exclusion Criteria
- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
Data sourced from ClinicalTrials.gov (NCT01153269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.