N/A N=33

Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

Human Immunodeficiency Virus-Infection

Bottom Line

View on ClinicalTrials.gov: NCT01153269 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2011

Primary outcome: Primary: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters — 64; 69 U/liter

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Lopinavir/Ritonavir (Kaletra) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters	52; 53	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY Viral Load	1.5	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—
PRIMARY CD4 Cell Count	525	—

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.

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

View full record on ClinicalTrials.gov →

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.