Trial Outcomes & Findings for Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection (NCT NCT01328158)
NCT ID: NCT01328158
Last Updated: 2014-12-22
Results Overview
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Recruitment status
COMPLETED
Target enrollment
236 participants
Primary outcome timeframe
Up to 60 Months
Results posted on
2014-12-22
Participant Flow
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.
Participant milestones
| Measure |
Lopinavir/Ritonavir
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|
|
Overall Study
STARTED
|
220
|
|
Overall Study
COMPLETED
|
220
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
Baseline characteristics by cohort
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
|
Presence/Absence of Previous Treatment of HIV-Infection
Absent
|
10 participants
n=5 Participants
|
|
Presence/Absence of Previous Treatment of HIV-Infection
Present
|
210 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Percentage of Participants With Adverse Drug Reactions
|
37.73 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..
Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as "Related", "Relationship cannot be ruled out", and "Unknown".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Adverse Drug Reactions
|
124 number of adverse drug reaction
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Male (n=205)
|
79 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Female (n=15)
|
4 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: 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.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=15 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Absence of pregnancy (n=10)
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Presence of pregnancy (n=5)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
≤ 14 Years (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
15 Years to ≤ 29 Years (n=10)
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
30 Years to ≤ 49 Years (n=158)
|
62 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
50 years to ≤ 64 Years (n=43)
|
15 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
≥ 65 Years (n=8)
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
Unknown/Undescribed (n=1)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Inpatient (n=2)
|
1 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Outpatient (n=191)
|
74 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Switching between Inpatient and Outpatient (n=27)
|
8 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Japanese (n=204)
|
74 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Other (n=16)
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Blood Product (n=17)
|
5 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Mother-to-Child Transmission (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Medical Accident (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Other (n=179)
|
70 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Unknown/Undescribed (n=24)
|
8 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
≤ 1 Year (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
1 Year to ≤ 2 Years (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
2 Years to ≤ 3 Years (n=2)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
3 Years to ≤ 4 Years (n=1)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
4 Years to ≤ 5 Years (n=2)
|
1 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
>5 Years (n=10)
|
6 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
Unknown/Undescribed (n=205)
|
76 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsParticipants 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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Absent (n=77)
|
24 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Present (n=137)
|
56 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Unknown/Undescribed (n=6)
|
3 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Absent (n=135)
|
41 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Present (n=67)
|
35 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Unknown/Undescribed (n=18)
|
7 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Absent (n=52)
|
14 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Present (n=168)
|
69 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Absent (n=217)
|
82 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Present (n=3)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Absent (n=159)
|
60 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Present (n=61)
|
23 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Hepatitis Present (n=49)
|
18 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Absent (n=203)
|
78 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Haemophilia A: Present (n=11)
|
4 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Haemophilia B: Present (n=6)
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=17 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
Without Hepatitis C (n=3)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
With Hepatitis C (n=14)
|
5 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
4 Tabs × 1 Time/Day (n=56)
|
17 participants
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
Unknown/Undescribed (n=1)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
2 Tabs × 2 Times/Day (n=156)
|
63 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
≤ 30 Days (n=5)
|
1 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
31 Days to ≤ 180 Days (n=27)
|
13 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
181 Days to ≤ 364 Days (n=19)
|
9 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
≥ 365 Days (n=168)
|
60 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
Unknown/Undescribed (n=1)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Absent (n=0)
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Present (n=220)
|
83 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
Absent (n=206)
|
76 participants
|
—
|
—
|
|
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 outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
NRTIs (n=214
|
81 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
NNRTIs (n=9)
|
6 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
Integrase Inhibitors (n=11)
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
CCR5 Inhibitors (n=0)
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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".
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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 outcome
Timeframe: Up to 60 MonthsPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=220 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
20 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=6 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=4 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 24 Months (n=0)
|
NA cells/mm^3
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 36 Months (n=0)
|
NA cells/mm^3
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 48 Months (n=0)
|
NA cells/mm^3
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 60 Months (n=0)
|
NA cells/mm^3
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=6 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
For subjects with plasma HIV-1 RNA quantified as \< 400 copies/mL, the result was recorded as 399 copies/mL.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=4 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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 0.0
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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
Standard Deviation NA
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 24 Months (n=0)
|
NA Log10 copies/mL
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 36 Months (n=0)
|
NA Log10 copies/mL
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 48 Months (n=0)
|
NA Log10 copies/mL
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
|
Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Use Duration: 60 Months (n=0)
|
NA Log10 copies/mL
Standard Deviation NA
No data available for assessment.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60 after first dose of Lopinavir/RitonavirPopulation: All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=9 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
n=5 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
n=206 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Category A After Treatment
|
4 participants
|
0 participants
|
39 participants
|
|
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Category B After Treatment
|
0 participants
|
0 participants
|
9 participants
|
|
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Category C After Treatment
|
0 participants
|
3 participants
|
36 participants
|
|
Number of Participants in Each CDC Classification Category of HIV-infection Over Time
CDC Category Unknown After Treatment
|
5 participants
|
2 participants
|
122 participants
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=6 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
|
—
|
—
|
|
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
No data available for assessment.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
No data available for assessment.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/RitonavirPopulation: Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
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.
Outcome measures
| Measure |
Lopinavir/Ritonavir
n=4 Participants
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category C
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
Lopinavir/Ritonavir: Baseline CDC Category Unknown
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|---|---|
|
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
No data available for assessment.
|
—
|
—
|
|
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
No data available for assessment.
|
—
|
—
|
|
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
No data available for assessment.
|
—
|
—
|
|
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
No data available for assessment.
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
Adverse Events
Lopinavir/Ritonavir
Serious events: 20 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lopinavir/Ritonavir
n=220 participants at risk
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|
|
Infections and infestations
AMOEBIASIS
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
CHRONIC HEPATITIS C
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
LYMPH NODE TUBERCULOSIS
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
MYCOBACTERIUM AVIUM COMPLEX INFECTION
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
HEPATITIS VIRUS-ASSOCIATED NEPHROPATHY
|
0.45%
1/220 • Up to 60 Months
|
|
Infections and infestations
HERPES ZOSTER MENINGITIS
|
0.45%
1/220 • Up to 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANAL CANCER
|
0.45%
1/220 • Up to 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER
|
0.45%
1/220 • Up to 60 Months
|
|
Immune system disorders
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME
|
0.45%
1/220 • Up to 60 Months
|
|
Eye disorders
CATARACT
|
0.45%
1/220 • Up to 60 Months
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.45%
1/220 • Up to 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
LARGE INTESTINE POLYP
|
0.45%
1/220 • Up to 60 Months
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.45%
1/220 • Up to 60 Months
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.91%
2/220 • Up to 60 Months
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.45%
1/220 • Up to 60 Months
|
|
Pregnancy, puerperium and perinatal conditions
THREATENED LABOUR
|
0.45%
1/220 • Up to 60 Months
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.45%
1/220 • Up to 60 Months
|
Other adverse events
| Measure |
Lopinavir/Ritonavir
n=220 participants at risk
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
|
|---|---|
|
Infections and infestations
SYPHILIS
|
0.91%
2/220 • Up to 60 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.45%
1/220 • Up to 60 Months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.91%
2/220 • Up to 60 Months
|
|
Endocrine disorders
BASEDOW'S DISEASE
|
0.45%
1/220 • Up to 60 Months
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.45%
1/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.91%
2/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
1.4%
3/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
10.0%
22/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
1.4%
3/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.45%
1/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.91%
2/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATASAEMIA
|
1.8%
4/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
LIPID METABOLISM DISORDER
|
0.45%
1/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
6.8%
15/220 • Up to 60 Months
|
|
Metabolism and nutrition disorders
HYPO HDL CHOLESTEROLAEMIA
|
0.45%
1/220 • Up to 60 Months
|
|
Psychiatric disorders
DEPRESSION
|
2.3%
5/220 • Up to 60 Months
|
|
Psychiatric disorders
INSOMNIA
|
2.3%
5/220 • Up to 60 Months
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.45%
1/220 • Up to 60 Months
|
|
Nervous system disorders
HEADACHE
|
0.91%
2/220 • Up to 60 Months
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.45%
1/220 • Up to 60 Months
|
|
Nervous system disorders
SCIATICA
|
0.45%
1/220 • Up to 60 Months
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.45%
1/220 • Up to 60 Months
|
|
Eye disorders
CORNEAL EROSION
|
0.45%
1/220 • Up to 60 Months
|
|
Eye disorders
CHORIORETINOPATHY
|
0.45%
1/220 • Up to 60 Months
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.45%
1/220 • Up to 60 Months
|
|
Ear and labyrinth disorders
TINNITUS
|
0.45%
1/220 • Up to 60 Months
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.45%
1/220 • Up to 60 Months
|
|
Vascular disorders
HYPERTENSION
|
0.91%
2/220 • Up to 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.91%
2/220 • Up to 60 Months
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.1%
9/220 • Up to 60 Months
|
|
Gastrointestinal disorders
GASTRITIS
|
0.45%
1/220 • Up to 60 Months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.91%
2/220 • Up to 60 Months
|
|
Gastrointestinal disorders
NAUSEA
|
0.45%
1/220 • Up to 60 Months
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
1.8%
4/220 • Up to 60 Months
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.45%
1/220 • Up to 60 Months
|
|
Hepatobiliary disorders
LIVER DISORDER
|
2.7%
6/220 • Up to 60 Months
|
|
Hepatobiliary disorders
DRUG-INDUCED LIVER INJURY
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.45%
1/220 • Up to 60 Months
|
|
Skin and subcutaneous tissue disorders
LIPODYSTROPHY ACQUIRED
|
0.45%
1/220 • Up to 60 Months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.45%
1/220 • Up to 60 Months
|
|
Musculoskeletal and connective tissue disorders
POLYARTHRITIS
|
0.45%
1/220 • Up to 60 Months
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.45%
1/220 • Up to 60 Months
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.45%
1/220 • Up to 60 Months
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.45%
1/220 • Up to 60 Months
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.45%
1/220 • Up to 60 Months
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.45%
1/220 • Up to 60 Months
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
2.3%
5/220 • Up to 60 Months
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.45%
1/220 • Up to 60 Months
|
|
General disorders
PYREXIA
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
BETA 2 MICROGLOBULIN URINE INCREASED
|
7.7%
17/220 • Up to 60 Months
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.91%
2/220 • Up to 60 Months
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
5.9%
13/220 • Up to 60 Months
|
|
Investigations
BLOOD URIC ACID INCREASED
|
1.4%
3/220 • Up to 60 Months
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.9%
13/220 • Up to 60 Months
|
|
Investigations
GLUCOSE URINE PRESENT
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
LIPIDS ABNORMAL
|
0.91%
2/220 • Up to 60 Months
|
|
Investigations
LOW DENSITY LIPOPROTEIN INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
PROTEIN URINE PRESENT
|
0.91%
2/220 • Up to 60 Months
|
|
Investigations
TRANSAMINASES INCREASED
|
0.45%
1/220 • Up to 60 Months
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
3.6%
8/220 • Up to 60 Months
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.45%
1/220 • Up to 60 Months
|
Additional Information
AbbVie Japan PMOS Desk
AbbVie (prior sponsor, Abbott)
Phone: +81-3-4577-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER