Clinical trial NCT01076972: Drug Use Investigation of Kaletra
Official title: Drug Use Investigation of Kaletra
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 1184
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital

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.


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

Primary outcomes:
measure: Total Number of Patients With Adverse Drug Reactions
timeFrame: During the course of the survey period up to Year 8
measure: Cluster of Differentiation 4 Lymphocyte Count (CD4)
timeFrame: 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
measure: Mean Number of Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Copies Per Milliliter (mL) Using a Logarithmic (Base 10) Transformation at Each Visit
timeFrame: 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
measure: Number of Patients Included in Each Center for Disease Control and Prevention (CDC) Classification Category for HIV-infected Adults and Adolescents
timeFrame: Baseline (Month 0) and following last treatment dose during the course of the survey period
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 36516
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 36517
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 36518
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 36519
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 36521
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 36522
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 36523
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 36524
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 36525
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 36526
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 36622
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 36623
city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 36624
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 36625
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 36626
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 36627
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 36628
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36629
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36630
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36631
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36632
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36633
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36634
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36635
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36636
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36637
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36638
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36639
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 5342
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Yo Hoshino
role: STUDY_DIRECTOR
References: