Human Immunodeficiency Virus Infection
Conditions
Keywords
Kaletra, Lopinavir (LPV)/Ritonavir (RTV), Human Immunodeficiency Virus (HIV) infection
Brief summary
This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug: 1. Incidence and conditions of occurrence of adverse reactions in the clinical setting 2. Factors that may affect the safety and effectiveness of Kaletra (QD)
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
Exclusion criteria
* Participants with a history of hypersensitivity to any ingredient of this drug. * Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions | Up to 60 Months | Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Adverse Drug Reactions | Up to 60 Months | Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Serious Adverse Events | Up to 60 Months | A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above. |
| Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | — |
| Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | — |
| Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL. |
| Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL. |
| Number of Participants in Each CDC Classification Category of HIV-infection Over Time | Up to Month 60 after first dose of Lopinavir/Ritonavir | CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease. |
| Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL. |
| Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir | Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
| Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy | Up to 60 Months | Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. |
Countries
Japan
Participant flow
Pre-assignment details
Survey forms were collected from 236 patients. 16 participants completed treatment with Lopinavir/Ritonavir tablets before the start of enrollment in this study and were excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Lopinavir/Ritonavir Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated | 220 |
| Total | 220 |
Baseline characteristics
| Characteristic | Lopinavir/Ritonavir |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 10.1 |
| Presence/Absence of Previous Treatment of HIV-Infection Absent | 10 participants |
| Presence/Absence of Previous Treatment of HIV-Infection Present | 210 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 99 / 220 |
| serious Total, serious adverse events | 20 / 220 |
Outcome results
Primary
Number of Adverse Drug Reactions
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lopinavir/Ritonavir | Number of Adverse Drug Reactions | 124 number of adverse drug reaction |
Primary
Percentage of Participants With Adverse Drug Reactions
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lopinavir/Ritonavir | Percentage of Participants With Adverse Drug Reactions | 37.73 percentage of participants |
Secondary
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 0 Months (n=4) | 654.5 cells/mm^3 | Standard Deviation 280.4 |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 60 Months (n=0) | NA cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 3 Months (n=1) | 657.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 6 Months (n=1) | 835.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 9 Months (n=2) | 713.5 cells/mm^3 | Standard Deviation 82.7 |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 12 Months (n=2) | 878.5 cells/mm^3 | Standard Deviation 229.8 |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 24 Months (n=0) | NA cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 36 Months (n=0) | NA cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 48 Months (n=0) | NA cells/mm^3 | — |
Secondary
Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 6 Months (n=1) | 190.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 9 Months (n=0) | NA cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 12 Months (n=1) | 104.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 24 Months (n=3) | 184.3 cells/mm^3 | Standard Deviation 225.4 |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 36 Months (n=2) | 330.0 cells/mm^3 | Standard Deviation 200.8 |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 48 Months (n=1) | 474.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 60 Months (n=1) | 377.0 cells/mm^3 | — |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 0 Months (n=6) | 144.5 cells/mm^3 | Standard Deviation 130.9 |
| Lopinavir/Ritonavir | Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 3 Months (n=0) | NA cells/mm^3 | — |
Secondary
Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation
For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 0 Months (n=6) | 5.2 Log10 copies/mL | Standard Deviation 0.8 |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 3 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 6 Months (n=1) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 9 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 36 Months (n=2) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 48 Months (n=1) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 60 Months (n=1) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 12 Months (n=1) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation | Use Duration: 24 Months (n=3) | 3.4 Log10 copies/mL | Standard Deviation 1.3 |
Secondary
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 0 Months (n=4) | 2.6 Log10 copies/mL | Standard Deviation 0 |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 9 Months (n=2) | 2.6 Log10 copies/mL | Standard Deviation 0 |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 12 Months (n=2) | 2.6 Log10 copies/mL | Standard Deviation 0 |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 24 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 36 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 48 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 60 Months (n=0) | NA Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 3 Months (n=1) | 2.6 Log10 copies/mL | — |
| Lopinavir/Ritonavir | Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation | Use Duration: 6 Months (n=1) | 2.6 Log10 copies/mL | — |
Secondary
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.
Time frame: Up to Month 60 after first dose of Lopinavir/Ritonavir
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category A After Treatment | 4 participants |
| Lopinavir/Ritonavir | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category B After Treatment | 0 participants |
| Lopinavir/Ritonavir | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category Unknown After Treatment | 5 participants |
| Lopinavir/Ritonavir | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category C After Treatment | 0 participants |
| Lopinavir/Ritonavir: Baseline CDC Category C | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category B After Treatment | 0 participants |
| Lopinavir/Ritonavir: Baseline CDC Category C | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category Unknown After Treatment | 2 participants |
| Lopinavir/Ritonavir: Baseline CDC Category C | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category C After Treatment | 3 participants |
| Lopinavir/Ritonavir: Baseline CDC Category C | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category A After Treatment | 0 participants |
| Lopinavir/Ritonavir: Baseline CDC Category Unknown | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category A After Treatment | 39 participants |
| Lopinavir/Ritonavir: Baseline CDC Category Unknown | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category B After Treatment | 9 participants |
| Lopinavir/Ritonavir: Baseline CDC Category Unknown | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category C After Treatment | 36 participants |
| Lopinavir/Ritonavir: Baseline CDC Category Unknown | Number of Participants in Each CDC Classification Category of HIV-infection Over Time | CDC Category Unknown After Treatment | 122 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | 2 Tabs × 2 Times/Day (n=156) | 63 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | 4 Tabs × 1 Time/Day (n=56) | 17 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | 2 × 2 Changing to 4 x 1 Tabs x Times/Day (n=5) | 1 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | Switch Between 2x2 and 4x1 Tabs x Times/Day (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | Other (3 Tabs x 2 Times as Other Daily Dose) (n=2) | 2 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir | Unknown/Undescribed (n=1) | 0 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | ≥ 65 Years (n=8) | 3 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | ≤ 14 Years (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | 15 Years to ≤ 29 Years (n=10) | 3 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | 30 Years to ≤ 49 Years (n=158) | 62 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | 50 years to ≤ 64 Years (n=43) | 15 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age | Unknown/Undescribed (n=1) | 0 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | A (n=9) | 2 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | P-0 (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | Unknown/Undescribed (n=206 | 81 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | B (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | C (n=5) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | P-1 (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment | P-2 (n=0) | 0 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | ≤ 1 Year (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | 1 Year to ≤ 2 Years (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | 2 Years to ≤ 3 Years (n=2) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | 3 Years to ≤ 4 Years (n=1) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | 4 Years to ≤ 5 Years (n=2) | 1 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | >5 Years (n=10) | 6 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration | Unknown/Undescribed (n=205) | 76 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender | Male (n=205) | 79 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender | Female (n=15) | 4 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia | Absent (n=203) | 78 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia | Haemophilia A: Present (n=11) | 4 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia | Haemophilia B: Present (n=6) | 1 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C | Without Hepatitis C (n=3) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C | With Hepatitis C (n=14) | 5 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient | Inpatient (n=2) | 1 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient | Outpatient (n=191) | 74 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient | Switching between Inpatient and Outpatient (n=27) | 8 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir | < Lopinavir 800/Ritonavir 200 mg (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir | Lopinavir 800/Ritonavir 200 mg (n=217) | 81 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir | > Lopinavir 800/Ritonavir 200 mg (n=3) | 2 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy | Unknown/Undescribed (n=18) | 7 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy | Absent (n=135) | 41 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy | Present (n=67) | 35 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs | Absent (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs | Present (n=220) | 83 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments | Absent (n=206) | 76 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments | Present (n=14) | 7 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases | Absent (n=52) | 14 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases | Present (n=168) | 69 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs | Absent (n=104) | 29 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs | Present (n=116) | 54 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder | Absent (n=159) | 60 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder | Present (n=61) | 23 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder | Hepatitis Present (n=49) | 18 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder | Absent (n=217) | 82 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder | Present (n=3) | 1 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History | Present (n=137) | 56 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History | Absent (n=77) | 24 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History | Unknown/Undescribed (n=6) | 3 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy | Absence of pregnancy (n=10) | 3 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy | Presence of pregnancy (n=5) | 1 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection | Absent (n=10) | 1 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection | Present (n=210) | 82 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races | Japanese (n=204) | 74 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races | Other (n=16) | 9 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Mother-to-Child Transmission (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Medical Accident (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Other (n=179) | 70 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Unknown/Undescribed (n=24) | 8 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection | Blood Product (n=17) | 5 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs | NNRTIs (n=9) | 6 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs | CCR5 Inhibitors (n=0) | 0 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs | NRTIs (n=214 | 81 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs | Integrase Inhibitors (n=11) | 3 participants |
Secondary
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | ≤ 30 Days (n=5) | 1 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | 31 Days to ≤ 180 Days (n=27) | 13 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | 181 Days to ≤ 364 Days (n=19) | 9 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | ≥ 365 Days (n=168) | 60 participants |
| Lopinavir/Ritonavir | Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir | Unknown/Undescribed (n=1) | 0 participants |
Secondary
Number of Participants With Serious Adverse Events
A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.
Time frame: Up to 60 Months
Population: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lopinavir/Ritonavir | Number of Participants With Serious Adverse Events | 20 participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 3 Months (n=1) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 6 Months (n=1) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 48 Months (n=0) | NA percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 60 Months (n=0) | NA percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 0 Months (n=4) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 9 Months (n=2) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 12 Months (n=2) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 24 Months (n=0) | NA percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants | At 36 Months (n=0) | NA percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants
Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Time frame: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Population: Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 12 Months (n=1) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 24 Months (n=3) | 66.7 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 36 Months (n=2) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 48 Months (n=1) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 0 Months (n=6) | 0.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 3 Months (n=0) | NA percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 6 Months (n=1) | 100.0 percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | AT 9 Months (n=0) | NA percentage of participants |
| Lopinavir/Ritonavir | Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants | At 60 Months (n=1) | 100.0 percentage of participants |