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

NCT01328158 | Completed Results

• 1 other identifier: P12-760
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 23

Brief 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. 1.Incidence and conditions of occurrence of adverse reactions in the clinical setting
2. 2.Factors that may affect the safety and effectiveness of Kaletra (QD)

Conditions

Human Immunodeficiency Virus Infection

Keywords

Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Drug Reactions

  Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".

  Up to 60 Months

• Number of Adverse Drug Reactions

  Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".

  Up to 60 Months

Secondary Outcomes (31)

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

  Up to 60 Months

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

  Up to 60 Months

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

  Up to 60 Months

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

  Up to 60 Months

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

  Up to 60 Months

Study Arms (1)

Lopinavir/Ritonavir

Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who receive Kaletra for the treatment of Human Immunodeficiency Virus infection per approved label

You may qualify if:

• \- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (23)

Site Reference ID/Investigator# 57629

Fukuoka, Japan

Location

Site Reference ID/Investigator# 57630

Hiroshima, Japan

Location

Site Reference ID/Investigator# 57631

Hokkaido, Japan

Location

Site Reference ID/Investigator# 57628

Kitakyushu-shi, Japan

Location

Site Reference ID/Investigator# 57638

Kurashiki-shi, Japan

Location

Site Reference ID/Investigator# 57634

Kyoto, Japan

Location

Site Reference ID/Investigator# 57625

Nagoya, Japan

Location

Site Reference ID/Investigator# 57626

Nagoya, Japan

Location

Site Reference ID/Investigator# 57637

Niigata, Japan

Location

Site Reference ID/Investigator# 57632

Nishinomiya-shi, Japan

Location

Site Reference ID/Investigator# 57639

Osaka, Japan

Location

Site Reference ID/Investigator# 57640

Osaka, Japan

Location

Site Reference ID/Investigator# 57636

Sendai, Japan

Location

Site Reference ID/Investigator# 48722

Tokyo, Japan

Location

Site Reference ID/Investigator# 57641

Tokyo, Japan

Location

Site Reference ID/Investigator# 57643

Tokyo, Japan

Location

Site Reference ID/Investigator# 57644

Tokyo, Japan

Location

Site Reference ID/Investigator# 57645

Tokyo, Japan

Location

Site Reference ID/Investigator# 57646

Tokyo, Japan

Location

Site Reference ID/Investigator# 57647

Tokyo, Japan

Location

Site Reference ID/Investigator# 57648

Tokyo, Japan

Location

Site Reference ID/Investigator# 57650

Tokyo, Japan

Location

Site Reference ID/Investigator# 57633

Yokohama, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: AbbVie Japan PMOS Desk
• Organization: AbbVie (prior sponsor, Abbott)

abvj-pmos@abbvie.com

+81-3-4577-1125

Study Officials

• Susumu Adachi, MD

  AbbVie G.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 4, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 22, 2014
• Results First Posted: December 22, 2014

Record last verified: 2014-12

Locations

JP (23)