N/A
Completed N=502
Kaletra in Combination With Antiretroviral Agents
Source: ClinicalTrials.gov NCT01076179 ↗Enrolled (actual)
502
Serious AEs
6.0%
Results posted
May 2017
Primary outcomePrimary: Prevalence of Adverse Events (Weeks 0-144), Per Event — 13.8; 19.3; 1.0; 4.4 percentage of adverse events
Summary
The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Adverse Events (Weeks 0-144), Per Event |
13.8; 19.3; 1.0; 4.4; 1.6; 1.8 | — |
| PRIMARY Prevalence of Adverse Events (Weeks 0-144), Per Participant |
14.8; 17.8; 3.0; 7.2; 2.8; 2.8 | — |
| SECONDARY Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count |
54.0; 64.6; 78.8; 95.8; 107.4; 131.0 | — |
| SECONDARY Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, Modified Intent-to-Treat Analysis |
23.8; 36.5; 45.7; 53.1; 58.1; 62.7 | — |
| SECONDARY Percentage of Participants Achieving Absolute CD4 Cell Count Increases From Baseline of ≥ 100 Cells/μL at All Time Points, As Treated Analysis |
32.2; 32.5; 37.9; 43.8; 48.0; 50.5 | — |
| SECONDARY Time to CD4 Cell Count Increase From Baseline of ≥ 100/ Cells/μL |
56.1 | — |
| SECONDARY Number of Participants With Lopinavir (LPV) Resistance at Baseline |
155; 4 | — |
| SECONDARY Number of Participants With LPV Resistance During Follow-Up |
5; 1 | — |
| SECONDARY Number of Participants With Protease Inhibitor (PI) Resistance at Baseline |
142; 17 | — |
| SECONDARY Number of Participants With PI Resistance During Follow-Up |
5; 1 | — |
| SECONDARY Number of Participants With INI Resistance at Baseline |
8; 1 | — |
| SECONDARY Number of Participants With INI Resistance During Follow-Up |
0; 2 | — |
| SECONDARY Number of Participants With NNRTI Resistance at Baseline |
113; 46 | — |
| SECONDARY Number of Participants With NNRTI Resistance During Follow-Up |
5; 1 | — |
| SECONDARY Number of Participants With Nucleoside Analog Reverse-Transcriptase Inhibitor (NRTI) Resistance at Baseline |
96; 63 | — |
| SECONDARY Number of Participants With NRTI Resistance During Follow-Up |
4; 2 | — |
| SECONDARY Number of Participants With HIV-1 Coreceptor Tropism at Baseline |
74; 21; 13 | — |
| SECONDARY Number of Participants With HIV-1 Coreceptor Tropism During Follow-up |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18years of age
- Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
- HIV-1 infection
- Patients treated with KALETRA®, independent from their participation in this study
- Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study
Exclusion Criteria
- Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
- Severe liver insufficiency
- No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort
Data sourced from ClinicalTrials.gov (NCT01076179). 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.