N/A
N=220
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Human Immunodeficiency Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01328158 ↗Enrolled (actual)
220
Serious AEs
9.1%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Participants With Adverse Drug Reactions — 37.73 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions |
37.73 | — |
| PRIMARY Number of Adverse Drug Reactions |
124 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender |
79; 4 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy |
3; 1 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age |
0; 3; 62; 15; 3; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient |
1; 74; 8 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection |
1; 82 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races |
74; 9 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection |
5; 0; 0; 70; 8 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration |
0; 0; 0; 0; 1; 6 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History |
24; 56; 3 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy |
41; 35; 7 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases |
14; 69 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder |
82; 1 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder |
60; 23; 18 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia |
78; 4; 1 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C |
0; 5 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir |
63; 17; 1; 0; 2; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir |
0; 81; 2 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir |
1; 13; 9; 60; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs |
0; 83 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments |
76; 7 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs |
81; 6; 3; 0 | — |
| SECONDARY Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs |
29; 54 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
20 | — |
| SECONDARY Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation |
144.5; NA; 190.0; NA; 104.0; 184.3 | — |
| SECONDARY Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation |
654.5; 657.0; 835.0; 713.5; 878.5; NA | — |
| SECONDARY Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation |
5.2; NA; 2.6; NA; 2.6; 3.4 | — |
| SECONDARY Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation |
2.6; 2.6; 2.6; 2.6; 2.6; NA | — |
| SECONDARY Number of Participants in Each CDC Classification Category of HIV-infection Over Time |
4; 0; 39; 0; 0; 9 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants |
0.0; NA; 100.0; NA; 100.0; 66.7 | — |
| SECONDARY Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants |
100.0; 100.0; 100.0; 100.0; 100.0; NA | — |
Summary
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:
1. Incidence and conditions of occurrence of adverse reactions in the clinical setting
2. Factors that may affect the safety and effectiveness of Kaletra (QD)
Eligibility Criteria
Inclusion Criteria
- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
Exclusion Criteria
- Participants with a history of hypersensitivity to any ingredient of this drug.
- Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
Data sourced from ClinicalTrials.gov (NCT01328158). 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.