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Drug Use Investigation of Kaletra

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ClinicalTrials.gov Identifier: NCT01076972
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : March 1, 2012
Last Update Posted : March 1, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date February 25, 2010
First Posted Date February 26, 2010
Results First Submitted Date December 9, 2011
Results First Posted Date March 1, 2012
Last Update Posted Date March 1, 2012
Study Start Date December 2000
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2012)
  • 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).
Original Primary Outcome Measures
 (submitted: February 25, 2010)
  • Evaluation of adverse event (occurrence of adverse event (yes or no), date of onset, diagnosis or definite symptom, details of symptom/course/intervention, seriousness, intensity, outcome, relationship to disease and drugs used) [ Time Frame: During survey period (every end of March) ]
  • Cluster of differentiation 4 lymphocyte count, number of Human Immunodeficiency Virus-ribo nucleic acid copies, Centers for Disease Control and Prevention classification [ Time Frame: During survey period (every end of March) ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Investigation of Kaletra
Official Title Drug Use Investigation of Kaletra
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospital
Condition Human Immunodeficiency Virus
Intervention Drug: Lopinavir/ritonavir (Kaletra)
Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
Other Names:
  • Lopinavir/ritonavir
  • Kaletra
Study Groups/Cohorts 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.
Intervention: Drug: Lopinavir/ritonavir (Kaletra)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 31, 2012)
1184
Original Actual Enrollment
 (submitted: February 25, 2010)
3887
Actual Study Completion Date December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01076972
Other Study ID Numbers PMOS-JAP-00-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators Not Provided
Investigators
Study Director: Yo Hoshino Abbott Japan Co.,Ltd
PRS Account Abbott
Verification Date January 2012