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Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Human Immunodeficiency Virus Infection

Phase: N/A

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Susumu Adachi, MD, Study Director, Affiliation: AbbVie G.K.

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)

Clinical Details

Official title: Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Percentage of Participants With Adverse Drug Reactions

Number of Adverse Drug Reactions

Secondary outcome:

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs

Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs

Number of Participants With Serious Adverse Events

Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation

Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation

Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation

Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation

Number of Participants in Each CDC Classification Category of HIV-infection Over Time

Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants

Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Site Reference ID/Investigator# 57629, Fukuoka-shi, Japan

Site Reference ID/Investigator# 57630, Hiroshima-shi, Japan

Site Reference ID/Investigator# 57631, Hokkaido, Japan

Site Reference ID/Investigator# 57628, Kitakyushu-shi, Japan

Site Reference ID/Investigator# 57638, Kurashiki-shi, Japan

Site Reference ID/Investigator# 57634, Kyoto, Japan

Site Reference ID/Investigator# 57625, Nagoya-shi, Japan

Site Reference ID/Investigator# 57626, Nagoya-shi, Japan

Site Reference ID/Investigator# 57637, Niigata, Japan

Site Reference ID/Investigator# 57632, Nishinomiya-shi, Japan

Site Reference ID/Investigator# 57639, Osaka-shi, Japan

Site Reference ID/Investigator# 57640, Osaka, Japan

Site Reference ID/Investigator# 57636, Sendai-shi, Japan

Site Reference ID/Investigator# 48722, Tokyo, Japan

Site Reference ID/Investigator# 57641, Tokyo, Japan

Site Reference ID/Investigator# 57643, Tokyo, Japan

Site Reference ID/Investigator# 57644, Tokyo, Japan

Site Reference ID/Investigator# 57645, Tokyo, Japan

Site Reference ID/Investigator# 57646, Tokyo, Japan

Site Reference ID/Investigator# 57647, Tokyo, Japan

Site Reference ID/Investigator# 57648, Tokyo, Japan

Site Reference ID/Investigator# 57650, Tokyo, Japan

Site Reference ID/Investigator# 57633, Yokohama-shi, Japan

Additional Information

Starting date: June 2011
Last updated: December 12, 2014

Page last updated: August 23, 2015

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