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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

April 1, 2011
January 16, 2014
June 2011
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01328158 on ClinicalTrials.gov Archive Site
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Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Drug Use Investigation of Kaletra Tablets (QD) on Patients With HIV-infection

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
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Human Immunodeficiency Virus Infection
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Kaletra
those with an exposure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

- Not specified

Both
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No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01328158
P12-760
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AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Yo Hoshino AbbVie G.K.
AbbVie
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP