Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Veeda Clinical Research
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01097655
First received: February 26, 2010
Last updated: February 20, 2015
Last verified: February 2015
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Purpose
Usage, dosing, tolerability, and effectiveness of Kaletra tablets in Human Immunodeficiency Virus-infected patients.
| Condition |
|---|
|
Human Immunodeficiency Virus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PMOS: Kaletra Tolerability |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
- Community sample; Human Immunodeficiency Virus-infected patients
- For Belgium: AIDS references centers (probability sample)
Criteria
Inclusion Criteria:
- Patients with Human Immunodeficiency Virus infection
- Patients that will be treated with KALETRA tablets, independent from their participation in this study
Exclusion Criteria:
- Hypersensitivity against Kaletra or other ingredients
- Severe liver insufficiency
- No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
- Patients that received more than 1 protease inhibitor during their therapy history are excluded
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097655
Show 109 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097655
Show 109 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Veeda Clinical Research
Investigators
| Study Director: | Bianca Wittig, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01097655 History of Changes |
| Other Study ID Numbers: | P06-131 |
| Study First Received: | February 26, 2010 |
| Last Updated: | February 20, 2015 |
| Health Authority: | Israel: Ministry of Health Belgium: Institutional Review Board Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AbbVie:
|
Viral load Tolerability Human immunodeficiency Virus Treatment-naïve |
Non Nucleoside Reverse Transcriptase Inhibitor Tablets Infection Effectiveness |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases |
Virus Diseases Reverse Transcriptase Inhibitors Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015