Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
Usage, dosing, tolerability, and effectiveness of Kaletra tablets in Human Immunodeficiency Virus-infected patients.
Human Immunodeficiency Virus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||PMOS: Kaletra Tolerability|
- Effectiveness Analysis: Cluster of differentiation 4 (CD4 count) [ Time Frame: Baseline, week 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 ] [ Designated as safety issue: No ]
- Effectiveness Analysis: Viral load [ Time Frame: Baseline, week 4, 12, 24, 36, 48, 60, 72, 84 , 96, 108, 120, 132 and 144 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Group A, HIV-infected patients
Group A: treatment-naïve patients starting with KALETRA tablets
Group B, HIV-infected patients
Group B: patients receiving their first Protease Inhibitor-containing regimen (apart from KALETRA) or any Non Nucleoside Reverse Transcriptase Inhibitor-containing regimen before starting with KALETRA tablets.
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra tablet. In some patients the study is to show the impact of changing therapy to Kaletra tablet from other regimens on tolerability.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097655
Show 109 Study Locations
|Study Director:||Bianca Wittig, MD||AbbVie Deutschland GmbH & Co. KG, Medical Department|