MedDataX Logo

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

NCT ID: NCT01328158

Last Updated: 2014-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Infection

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lopinavir/Ritonavir

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susumu Adachi, MD

Role: STUDY_DIRECTOR

AbbVie G.K.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 57629

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 57630

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 57631

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 57628

Kitakyushu-shi, , Japan

Site Status

Site Reference ID/Investigator# 57638

Kurashiki-shi, , Japan

Site Status

Site Reference ID/Investigator# 57634

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 57625

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 57626

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 57637

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 57632

Nishinomiya-shi, , Japan

Site Status

Site Reference ID/Investigator# 57639

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 57640

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 57636

Sendai, , Japan

Site Status

Site Reference ID/Investigator# 48722

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57641

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57643

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57644

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57645

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57646

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57647

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57648

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57650

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 57633

Yokohama, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

http://rxabbvie.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P12-760

Identifier Type: -

Identifier Source: org_study_id