N/A
N=2,288
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
HIV-1 Patients
Bottom Line
View on ClinicalTrials.gov: NCT01379703 ↗Enrolled (actual)
2,288
Serious AEs
2.0%
Results posted
Sep 2011
Primary outcome: Primary: CD4 Count — 229.9; 208.8; 246.8 cells per mm³
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD4 Count |
229.9; 208.8; 246.8 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Changes in CD4 Count |
429.7; 222.2 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Viral Load |
2.35; -1.95 | — |
| PRIMARY Laboratory Parameter Blood Glucose |
4.87; 4.89; 4.85; 4.92; 4.87; 4.99 | — |
| PRIMARY Laboratory Parameter Transaminases |
38.9; 36.8; 41.4; 35.2; 34.8; 36.0 | — |
| PRIMARY Laboratory Parameter Lipids |
4.37; 4.48; 4.28; 4.96; 5.07; 4.89 | — |
| SECONDARY Reasons for Discontinuation of Lopinavir/Ritonavir |
352; 239; 20; 17; 7; 6 | — |
| SECONDARY Reasons for Discontinuation of Lopinavir/Ritonavir |
352; 239; 20; 17; 7; 6 | — |
| SECONDARY Compliance With Lopinavir/Ritonavir |
616; 578; 12 | — |
| SECONDARY Compliance With Lopinavir/Ritonavir |
616; 578; 12 | — |
| SECONDARY Adverse Events Observed on Treatment With Lopinavir/Ritonavir. |
260; 175; 78 | — |
Summary
KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.
The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.
The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.
Eligibility Criteria
Inclusion Criteria
Patients infected by HIV-1 infection who are either:
- Antiretroviral treatment (ART) naive or
- Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
- Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).
A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.
Exclusion Criteria
- Treatment with drugs at risk for interactions with lopinavir/ritonavir
- Uncontrolled AIDS defining disease
- Two or more previous Protease inhibitors (PIs)
- Participation in another study or clinical trial
Data sourced from ClinicalTrials.gov (NCT01379703). 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.