Drug Use Investigation of Kaletra
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| ClinicalTrials.gov Identifier: NCT01076972 |
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Recruitment Status :
Completed
First Posted : February 26, 2010
Results First Posted : March 1, 2012
Last Update Posted : March 1, 2012
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Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
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Brief Summary:
This non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (Kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in Japan.
| Condition or disease | Intervention/treatment |
|---|---|
| Human Immunodeficiency Virus | Drug: Lopinavir/ritonavir (Kaletra) |
| Study Type : | Observational |
| Actual Enrollment : | 1184 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Drug Use Investigation of Kaletra |
| Study Start Date : | December 2000 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Lopinavir/ritonavir group
All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
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Drug: Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Other Names:
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Primary Outcome Measures :
- Total Number of Patients With Adverse Drug Reactions [ Time Frame: During the course of the survey period up to Year 8 ]Number of patients with adverse drug reactions, defined as adverse events for which the causal relationship with Kaletra was something other than "not related" by the investigator (i.e., "probable," "possible," or "unclear"), that occurred in ≥ 5% of patients. Adverse drug reactions are reported by preferred term and inclusive of all those reported at each visit. Although a patient may experience a particular preferred term more than once, each patient was counted only once for each preferred term.
- Cluster of Differentiation 4 Lymphocyte Count (CD4) [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]The evolution of patients' CD4-positive (CD4+) T-lymphocyte counts after starting treatment with Kaletra was assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ counts are reported as the number of CD4+ cells per cubic millimeter (cmm) and presented by the mean at each visit. Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of patients naive to previous antiretroviral treatment and those that were not who had CD4+ T-cell counts available for analysis at each study visit.
- Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit [ Time Frame: Baseline (Month 0), every 3 months thereafter up to Month 12 and every year thereafter up to Year 8 (Month 96) during the course of the survey period ]Number of HIV RNA copies per mL is presented by the mean per visit for patients that were naive to previous antiretroviral treatment and those that were not. HIV-RNA data reported as < 400 copies/mL were considered 399 copies/mL in calculations. The mean and standard deviation of HIV-RNA levels were thus calculated after logarithmic (base 10) transformation (log10 399 is 2.6). Only observed cases were included in analyses; no data were imputed. n = xx, xx is the number of treatment-naive, treatment-experienced participants who had CD4+ T-cell counts available for analysis at each study visit.
- Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents [ Time Frame: Baseline (Month 0) and following last treatment dose during the course of the survey period ]Number of patients in each CDC category at Baseline (last assessment within 30 days prior to first dose of Kaletra) and after treatment. CDC categories defined as: Category A (asymptomatic acute HIV infection), Category B (symptomatic HIV infection; not Categories A and C), Category C (acquired immunodeficiency syndrome [AIDS] indicator status), Class P-0 (children not confirmed for HIV infection), Class P-1 (children with asymptomatic HIV infection), or Class P-2 (children with symptomatic HIV infection).
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hospital
Criteria
Inclusion Criteria:
- All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.
Exclusion Criteria:
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Contraindications according to the Package Insert:
- Patients with a history of hypersensitivity to any ingredient of Kaletra
- Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01076972
Locations
Show 29 study locations
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Yo Hoshino | Abbott Japan Co.,Ltd |
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01076972 |
| Other Study ID Numbers: |
PMOS-JAP-00-001 |
| First Posted: | February 26, 2010 Key Record Dates |
| Results First Posted: | March 1, 2012 |
| Last Update Posted: | March 1, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Abbott:
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Human Immunodeficiency Virus |
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |