N/A
N=284
Evaluation of Kaletra Therapy Over the Long-term
Human Immunodeficiency Virus
Bottom Line
View on ClinicalTrials.gov: NCT01083810 ↗Enrolled (actual)
284
Serious AEs
5.6%
Results posted
Jul 2011
Primary outcome: Primary: Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs — 137; 68; 55; 122 Participants
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
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs |
137; 68; 55; 122; 68; 55 | — |
| SECONDARY Percentage of Patients With HIV-1 RNA <50 Copies/ml |
0; 3; 0; 7; 26; 5 | — |
| SECONDARY Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml |
1; 5; 0; 17; 15; 14 | — |
| SECONDARY Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml |
0; 3; 0; 18; 12; 19 | — |
| SECONDARY Percentage of Patients With HIV-1 RNA >500 Copies/ml |
99; 89; 100; 59; 46; 63 | — |
| SECONDARY Change in Absolute CD4 Cell Count [CD4+ Cells/µL] |
0; 0; 0; 140; 68; 131 | — |
Summary
Long term observation of patients under lopinavir/ritonavir containing therapy
Eligibility Criteria
Inclusion Criteria
- Patients infected by HIV-1
- Age greater than or equal to 18 years
Exclusion Criteria
- as described in SmPC (summary of product characteristics) at the time of prescription
Data sourced from ClinicalTrials.gov (NCT01083810). 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.