Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01328158
First received: April 1, 2011
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
This study of Kaletra tablets will be conducted to clarify the following with regard to treatment with this drug:
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Lopinavir
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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
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# 57636 | |
| Miyagi, 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# 57640 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 57639 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 57645 | |
| Ota-ku, Tokyo, Japan | |
| Site Reference ID/Investigator# 57644 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 57650 | |
| Tokyo, 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# 57646 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 57647 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 57648 | |
| 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: | April 12, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AbbVie:
|
Human Immunodeficiency Virus infection |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Virus Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013