Human Immunodeficiency Virus
Conditions
Keywords
Tablets, Infection, Non Nucleoside Reverse Transcriptase Inhibitor, Tolerability, Viral load, Human immunodeficiency Virus, Effectiveness, Treatment-naïve
Brief summary
The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.
Detailed description
This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
Interventions
None listed
Sponsors
Veeda Clinical Research
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Adverse Events (Weeks 0-144), Per Event | 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 | 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'). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HIV-infected Participants HIV-infected participants starting with Kaletra tablets. | 3,039 |
| Total | 3,039 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Meet Inclusion Criteria | 8 |
| Overall Study | Subject Documented Twice | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | HIV-infected Participants |
|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 595 Participants |
| Sex: Female, Male Male | 2444 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 79 / 3,039 |
Outcome results
Primary
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count
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.
Time frame: Baseline (Week 0) to Week 144
Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 4 | 99.8 cells/μL | Standard Deviation 145.2 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 12 | 133.3 cells/μL | Standard Deviation 148.7 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 24 | 160.5 cells/μL | Standard Deviation 177.6 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 36 | 185.9 cells/μL | Standard Deviation 181.2 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 48 | 213.6 cells/μL | Standard Deviation 225.1 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 60 | 228.4 cells/μL | Standard Deviation 204.6 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 72 | 250.1 cells/μL | Standard Deviation 205.1 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 84 | 263.8 cells/μL | Standard Deviation 214.8 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 96 | 276.3 cells/μL | Standard Deviation 212.8 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 108 | 291.0 cells/μL | Standard Deviation 247.6 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 120 | 294.3 cells/μL | Standard Deviation 216.5 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 132 | 303.8 cells/μL | Standard Deviation 229.3 |
| HIV-infected Participants | Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count | Change at Week 144 | 316.1 cells/μL | Standard Deviation 228.2 |
Primary
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load
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.
Time frame: Baseline (Week 0) to Week 144
Population: Participants with an assessment at Baseline. Number analyzed=participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 84 | -2.92 log copies/mL | Standard Deviation 1.37 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 4 | -1.90 log copies/mL | Standard Deviation 0.97 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 12 | -2.53 log copies/mL | Standard Deviation 1.23 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 24 | -2.83 log copies/mL | Standard Deviation 1.35 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 36 | -2.89 log copies/mL | Standard Deviation 1.4 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 48 | -2.89 log copies/mL | Standard Deviation 1.41 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 60 | -2.93 log copies/mL | Standard Deviation 1.38 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 72 | -2.92 log copies/mL | Standard Deviation 1.36 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 96 | -2.93 log copies/mL | Standard Deviation 1.38 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 108 | -2.93 log copies/mL | Standard Deviation 1.39 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 120 | -2.92 log copies/mL | Standard Deviation 1.36 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 132 | -2.94 log copies/mL | Standard Deviation 1.36 |
| HIV-infected Participants | Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load | Change at Week 144 | -2.97 log copies/mL | Standard Deviation 1.34 |
Other Pre-specified
Prevalence of Adverse Events (Weeks 0-144), Per Event
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').
Time frame: Weeks 0 to 144
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Hypertriglyceridemia | 12.4 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Hypercholesterolemia | 19.3 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Low HDL Cholesterol | 0.5 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | High LDL Cholesterol | 2.3 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Hyperglycemia | 3.0 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Hyperbilirubinemia | 2.7 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Elevated AST | 3.5 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Elevated ALT | 4.1 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Elevated γGT | 7.3 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Elevated Alkaline Phosphatase | 3.1 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Stomatitis | 0.6 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Nausea | 4.2 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Vomiting | 1.5 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Diarrhea | 18.3 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Abdominal Pain | 2.9 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Mood Disorder | 5.0 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Neurocerebellar Disorder | 0.6 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Neurocontrol Disorder | 0.0 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Headache | 1.9 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Fatigue | 4.0 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Fever | 1.4 percentage of adverse events |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Event | Not Specified | 4.8 percentage of adverse events |
Other Pre-specified
Prevalence of Adverse Events (Weeks 0-144), Per Participant
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').
Time frame: Weeks 0 to 144
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Hypertriglyceridemia | 14.1 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Hypercholesterolemia | 16.3 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Low HDL Cholesterol | 1.6 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | High LDL Cholesterol | 4.0 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Hyperglycemia | 5.8 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Abdominal Pain | 8.0 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Hyperbilirubinemia | 3.9 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Elevated AST | 6.7 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Elevated ALT | 7.5 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Elevated γGT | 9.3 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Elevated Alkaline Phosphatase | 4.7 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Stomatitis | 2.0 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Nausea | 11.5 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Vomiting | 4.6 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Diarrhea | 32.7 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Mood Disorder | 9.0 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Neurocerebellar Disorder | 1.7 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Neurocontrol Disorder | 0.0 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Headache | 5.2 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Fatigue | 8.7 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Fever | 4.4 percentage of participants |
| HIV-infected Participants | Prevalence of Adverse Events (Weeks 0-144), Per Participant | Not Specified | 30.4 percentage of participants |