N/A
Completed N=3,049
Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
Source: ClinicalTrials.gov NCT01097655 ↗Enrolled (actual)
3,049
Serious AEs
2.6%
Results posted
May 2017
Primary outcomePrimary: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count — 99.8; 133.3; 160.5; 185.9 cells/μL
Summary
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count |
99.8; 133.3; 160.5; 185.9; 213.6; 228.4 | — |
| PRIMARY Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load |
-1.90; -2.53; -2.83; -2.89; -2.89; -2.93 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with HIV infection
- Patients that will be treated with Kaletra tablets independent from their participation in this study
Exclusion Criteria
- Hypersensitivity against Kaletra or other ingredients
- Severe liver insufficiency
- No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
- Patients who received more than 1 protease inhibitor during their therapy history
Data sourced from ClinicalTrials.gov (NCT01097655). 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.