Drug Use Investigation of Kaletra

Human Immunodeficiency Virus Clinical Trial

Official title:

Drug Use Investigation of Kaletra

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076972
• Other study ID #: PMOS-JAP-00-001
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: January 31, 2012
• Start date: December 2000
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients prescribed Kaletra for the treatment of HIV are eligible for this survey.

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Locations

Country	Name	City	State
Japan	Site Reference ID/Investigator# 36516	Aichi
Japan	Site Reference ID/Investigator# 36517	Aichi
Japan	Site Reference ID/Investigator# 36518	Chiba
Japan	Site Reference ID/Investigator# 36519	Fukuoka
Japan	Site Reference ID/Investigator# 36521	Fukuoka
Japan	Site Reference ID/Investigator# 36522	Hiroshima
Japan	Site Reference ID/Investigator# 36523	Hokkaido
Japan	Site Reference ID/Investigator# 36524	Hyogo
Japan	Site Reference ID/Investigator# 36525	Kanagawa
Japan	Site Reference ID/Investigator# 36526	Kyoto
Japan	Site Reference ID/Investigator# 36622	Miyagi
Japan	Site Reference ID/Investigator# 36623	Miyagi
Japan	Site Reference ID/Investigator# 36624	Niigata
Japan	Site Reference ID/Investigator# 36625	Okayama
Japan	Site Reference ID/Investigator# 36626	Osaka
Japan	Site Reference ID/Investigator# 36627	Osaka
Japan	Site Reference ID/Investigator# 36628	Shizuoka
Japan	Site Reference ID/Investigator# 36629	Tokyo
Japan	Site Reference ID/Investigator# 36630	Tokyo
Japan	Site Reference ID/Investigator# 36631	Tokyo
Japan	Site Reference ID/Investigator# 36632	Tokyo
Japan	Site Reference ID/Investigator# 36633	Tokyo
Japan	Site Reference ID/Investigator# 36634	Tokyo
Japan	Site Reference ID/Investigator# 36635	Tokyo
Japan	Site Reference ID/Investigator# 36636	Tokyo
Japan	Site Reference ID/Investigator# 36637	Tokyo
Japan	Site Reference ID/Investigator# 36638	Tokyo
Japan	Site Reference ID/Investigator# 36639	Tokyo
Japan	Site Reference ID/Investigator# 5342	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Patients With Adverse Drug Reactions	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.	During the course of the survey period up to Year 8	Yes
Primary	Cluster of Differentiation 4 Lymphocyte Count (CD4)	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.	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	No
Primary	Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit	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.	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	No
Primary	Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents	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).	Baseline (Month 0) and following last treatment dose during the course of the survey period	No