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This single-arm, multi-center, Post-Marketing Surveillance study of Kaletra (lopinavir/ritonavir) was conducted in accordance with the approved Korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (HIV-1) infection.
Participants were observed for up to 48 weeks following the first dose of Kaletra. A follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. Clinical/immunological/virological/laboratory status, Kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HIV-1 infection | Participants treated with Kaletra (lopinavir/ritonavir 200 mg/50 mg and 100 mg/25 mg) tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose. | From the start of treatment until 30 days after the last dose, up to 52 weeks |
| Number of Participants Who Interrupted or Discontinued Kaletra Treatment | At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc). | Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment |
| Percentage of Participants With Viral Load Below 400 Copies/mL | Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Week 24 |
| Percentage of Participants With Viral Load Below 50 Copies/mL | Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Viral Load | This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated. | Week 24 & 48 |
| Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts |
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Inclusion Criteria:
Exclusion Criteria:
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general hospitals
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| Name | Affiliation | Role |
|---|---|---|
| SoRa Lee, MD | AbbVie Ltd. | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Main Surveillance | The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks. |
| FG001 | Long-term Surveillance | The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Surveillance: Safety Group |
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| Main Surveillance: Effectiveness Group |
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| Long-term Surveillance: Safety Group |
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| Long-term Surveillance: Effectiveness Gr |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Adverse events were recorded during the 48-week surveillance period and until 30 days following the last dose. | Participants with available data | Posted | Number | participants | From the start of treatment until 30 days after the last dose, up to 52 weeks |
|
From the start of treatment until 30 days after the last dose, up to 52 weeks
Adverse event(s) details, including the type of adverse event(s), onset/end date, severity, action taken, and relationship to the drug and the investigator's view on the adverse event(s) (whether it was related to the drug or not) were recorded during the 48-week surveillance period and until 30 days following the last dose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Surveillance | All participants who received at least one dose of Kaletra |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks. |
| From baseline to Weeks 24 and 48 |
| Percentage of Participants With Confirmed Viral Resistance | Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance. | From baseline through weeks 24 and 48 |
| Mean Time to Treatment Failure | Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48. | From baseline through weeks 24 and 48 |
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| years |
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| Sex/Gender, Customized | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Participants Who Interrupted or Discontinued Kaletra Treatment | At 24 and 48 weeks after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment, the investigator documented Kaletra status (on-going, permanently discontinued, lost to follow-up, etc). | Participants with available data | Posted | Number | participants | Weeks 24 and 48 after initiation of Kaletra treatment or upon permanent discontinuation of Kaletra treatment |
|
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| Primary | Percentage of Participants With Viral Load Below 400 Copies/mL | Blood samples were obtained from participants 24 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Participants with available data | Posted | Number | percentage of participants | Week 24 |
|
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| Secondary | Change From Baseline in Viral Load | This variable, change from baseline in viral load, was not included in the final protocol. Therefore, these data were not calculated. | Posted | Week 24 & 48 |
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| Secondary | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts | Blood samples were obtained from participants at baseline, 24, and 48 weeks after the start of Kaletra treatment and analyzed for CD4 cell counts. Change in CD4 cell counts in the main surveillance population was calculated by subtracting the value at baseline from the value at 24 weeks. Change in CD4 cell counts in the long-term surveillance population was calculated by subtracting the value at baseline from the value at 48 weeks. | Participants with available data | Posted | Mean | Standard Deviation | cells/mm˄3 | From baseline to Weeks 24 and 48 |
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| Secondary | Percentage of Participants With Confirmed Viral Resistance | Blood samples were obtained from participants at initiation of Kaletra treatment and follow up visits through weeks 24 and 48 and analyzed for genotypic viral resistance. | Participants with available data | Posted | Number | percentage of participants | From baseline through weeks 24 and 48 |
|
|
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| Secondary | Mean Time to Treatment Failure | Blood samples were obtained from participants at initiation of Kaletra treatment and at follow up visits through weeks 24 and 48 and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. Treatment failure was defined as HIV RNA level > 400 copies/mL at week 24 and HIV RNA level > 50 copies/mL at week 48. | Participants with available data | Posted | Mean | Standard Error | days | From baseline through weeks 24 and 48 |
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| Primary | Percentage of Participants With Viral Load Below 50 Copies/mL | Blood samples were obtained from participants 48 weeks after the start of Kaletra treatment, and analyzed for human immunodeficiency virus-1 (HIV-1) RNA levels. | Participants with available data | Posted | Number | percentage of participants | Week 48 |
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| 51 |
| 580 |
| 222 |
| 580 |
| EG001 | Long-term Surveillance | Participants who received Kaletra for more than 24 weeks | 39 | 479 | 169 | 479 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Liver disorder | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Disseminated tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Mycobacterial infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Spleen tuberculosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 17.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| < 0.0001 |
| 2-Sided |
| No |
| Superiority or Other |