N/A
Completed N=60
Kaletra: Therapy With Double Protease Inhibitors
Source: ClinicalTrials.gov NCT01075191 ↗Enrolled (actual)
60
Serious AEs
6.2%
Results posted
Oct 2012
Primary outcomePrimary: Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL — 8.6; 26.2; 40.0; 56.3 percentage of participants
Summary
Therapy with lopinavir/ritonavir (Kaletra) and one other protease inhibitor in Human Immunodeficiency Virus participants
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL |
8.6; 26.2; 40.0; 56.3; 69.1; 65.9 | — |
| SECONDARY Change From Baseline in Absolute CD4 Cell Count |
312.0; 48.2; 115.7; 124.5; 122.6; 129.0 | — |
| SECONDARY Change From Baseline in Relative CD4 Cell Count |
16.8; 1.4; 2.8; 4.1; 4.9; 4.9 | — |
| SECONDARY Change From Baseline in Absolute CD8 Cell Count |
1180.8; 109; 195; 66; -59; -105 | — |
| SECONDARY Change From Baseline in Relative CD8 Cell Count |
60.4; -2.2; -2.1; -7.1; -8.2; -8.6 | — |
| SECONDARY Change From Baseline in CD4/CD8 T-cell Ratio |
0.3; 0.1; 0.1; 0.1; 0.2; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with Human Immunodeficiency Virus infection
- Participants on lopinavir/ritonavir (Kaletra) and one other protease inhibitor
Exclusion Criteria
- Hypersensitivity against lopinavir, ritonavir or other ingredients
- Severe liver insufficiency
- No concomitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Data sourced from ClinicalTrials.gov (NCT01075191). 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.