Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet
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ClinicalTrials.gov Identifier: NCT01097655 |
Recruitment Status
:
Completed
First Posted
: April 2, 2010
Results First Posted
: May 23, 2017
Last Update Posted
: May 23, 2017
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Condition or disease |
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Human Immunodeficiency Virus |
Study Type : | Observational |
Actual Enrollment : | 3049 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |

Group/Cohort |
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HIV-infected Participants
HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups:
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- Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count [ Time Frame: Baseline (Week 0) to Week 144 ]Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
- Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load [ Time Frame: Baseline (Week 0) to Week 144 ]Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.
- Prevalence of Adverse Events (Weeks 0-144), Per Event [ Time Frame: Weeks 0 to 144 ]Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
- Prevalence of Adverse Events (Weeks 0-144), Per Participant [ Time Frame: Weeks 0 to 144 ]Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
- Community sample; HIV-infected patients
- For Belgium: AIDS references centers (probability sample)
Inclusion Criteria:
- Patients with HIV 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 who received more than 1 protease inhibitor during their therapy history

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097655
Study Director: | Sandra Bloch, MD | AbbVie Deutschland GmbH & Co. KG, Medical Department |
Additional Information:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01097655 History of Changes |
Other Study ID Numbers: |
P06-131 |
First Posted: | April 2, 2010 Key Record Dates |
Results First Posted: | May 23, 2017 |
Last Update Posted: | May 23, 2017 |
Last Verified: | May 2017 |
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Tablets Infection Non Nucleoside Reverse Transcriptase Inhibitor Tolerability |
Viral load Human immunodeficiency Virus Effectiveness Treatment-naïve |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Reverse Transcriptase Inhibitors |
Lopinavir Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |