Drug Use Investigation of Kaletra

Abbott1,184 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,184

Conditions

Human Immunodeficiency Virus

Interventions

Lopinavir/ritonavir (Kaletra)DRUG

Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (29)

Site Reference ID/Investigator# 36516

Outcomes

Primary Outcomes

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.

Time frame: During the course of the survey period up to Year 8

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.

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

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.

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

Data from ClinicalTrials.gov

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