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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01328158
First received: April 1, 2011
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This study of Kaletra 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

Condition
Human Immunodeficiency Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Kaletra Tablets (QD) on Patients With HIV-infection

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: at week 52 ] [ Designated as safety issue: Yes ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Kaletra

  • Cluster of differentiation 4 lymphocyte count, number of Human Immunodeficiency Virus-ribo nucleic acid copies, Centers for Disease Control and Prevention classification [ Time Frame: at week 52 ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Kaletra
those with an exposure

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who receive Kaletra for the treatment of Human Immunodeficiency Virus infection

Criteria

Inclusion Criteria:

- All patients who receive Kaletra for the treatment of Human Immunodeficiency Virus infection

Exclusion Criteria:

- Not specified

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328158

Locations
Japan
Site Reference ID/Investigator# 57629
Fukuoka, Japan
Site Reference ID/Investigator# 57630
Hiroshima, Japan
Site Reference ID/Investigator# 57631
Hokkaido, Japan
Site Reference ID/Investigator# 57628
Kitakyushu, Japan
Site Reference ID/Investigator# 57638
Kurashiki, Japan
Site Reference ID/Investigator# 57634
Kyoto, Japan
Site Reference ID/Investigator# 57625
Nagoya, Japan
Site Reference ID/Investigator# 57626
Nagoya, Japan
Site Reference ID/Investigator# 57637
Niigata, Japan
Site Reference ID/Investigator# 57632
Nishinomiya, Japan
Site Reference ID/Investigator# 57639
Osaka, Japan
Site Reference ID/Investigator# 57640
Osaka, Japan
Site Reference ID/Investigator# 57645
Ota-ku, Tokyo, Japan
Site Reference ID/Investigator# 57636
Sendai, Japan
Site Reference ID/Investigator# 48722
Tokyo, Japan
Site Reference ID/Investigator# 57648
Tokyo, Japan
Site Reference ID/Investigator# 57647
Tokyo, Japan
Site Reference ID/Investigator# 57650
Tokyo, Japan
Site Reference ID/Investigator# 57641
Tokyo, Japan
Site Reference ID/Investigator# 57646
Tokyo, Japan
Site Reference ID/Investigator# 57643
Tokyo, Japan
Site Reference ID/Investigator# 57644
Tokyo, Japan
Site Reference ID/Investigator# 57633
Yokohama, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Yo Hoshino AbbVie G.K.
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01328158     History of Changes
Other Study ID Numbers: P12-760
Study First Received: April 1, 2011
Last Updated: January 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Human Immunodeficiency Virus infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014