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Trial record 7 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

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ClinicalTrials.gov Identifier: NCT01328158
Recruitment Status : Completed
First Posted : April 4, 2011
Results First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus Infection
Enrollment 236
Recruitment Details  
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.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Period Title: Overall Study
Started 220
Completed 220
Not Completed 0
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Baseline Participants 220
Hide Baseline Analysis Population Description
All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 220 participants
43.6  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants
Female
15
   6.8%
Male
205
  93.2%
Presence/Absence of Previous Treatment of HIV-Infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 220 participants
Absent 10
Present 210
1.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: percentage of participants
37.73
2.Primary Outcome
Title Number of Adverse Drug Reactions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: number of adverse drug reaction
124
3.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Male (n=205) 79
Female (n=15) 4
4.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
Absence of pregnancy (n=10) 3
Presence of pregnancy (n=5) 1
5.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
≤ 14 Years (n=0) 0
15 Years to ≤ 29 Years (n=10) 3
30 Years to ≤ 49 Years (n=158) 62
50 years to ≤ 64 Years (n=43) 15
≥ 65 Years (n=8) 3
Unknown/Undescribed (n=1) 0
6.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Inpatient (n=2) 1
Outpatient (n=191) 74
Switching between Inpatient and Outpatient (n=27) 8
7.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=10) 1
Present (n=210) 82
8.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Japanese (n=204) 74
Other (n=16) 9
9.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Blood Product (n=17) 5
Mother-to-Child Transmission (n=0) 0
Medical Accident (n=0) 0
Other (n=179) 70
Unknown/Undescribed (n=24) 8
10.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
≤ 1 Year (n=0) 0
1 Year to ≤ 2 Years (n=0) 0
2 Years to ≤ 3 Years (n=2) 0
3 Years to ≤ 4 Years (n=1) 0
4 Years to ≤ 5 Years (n=2) 1
>5 Years (n=10) 6
Unknown/Undescribed (n=205) 76
11.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=77) 24
Present (n=137) 56
Unknown/Undescribed (n=6) 3
12.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=135) 41
Present (n=67) 35
Unknown/Undescribed (n=18) 7
13.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=52) 14
Present (n=168) 69
14.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=217) 82
Present (n=3) 1
15.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=159) 60
Present (n=61) 23
Hepatitis Present (n=49) 18
16.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=203) 78
Haemophilia A: Present (n=11) 4
Haemophilia B: Present (n=6) 1
17.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Without Hepatitis C (n=3) 0
With Hepatitis C (n=14) 5
18.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
A (n=9) 2
B (n=0) 0
C (n=5) 0
P-0 (n=0) 0
P-1 (n=0) 0
P-2 (n=0) 0
Unknown/Undescribed (n=206 81
19.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
2 Tabs × 2 Times/Day (n=156) 63
4 Tabs × 1 Time/Day (n=56) 17
2 × 2 Changing to 4 x 1 Tabs x Times/Day (n=5) 1
Switch Between 2x2 and 4x1 Tabs x Times/Day (n=0) 0
Other (3 Tabs x 2 Times as Other Daily Dose) (n=2) 2
Unknown/Undescribed (n=1) 0
20.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
< Lopinavir 800/Ritonavir 200 mg (n=0) 0
Lopinavir 800/Ritonavir 200 mg (n=217) 81
> Lopinavir 800/Ritonavir 200 mg (n=3) 2
21.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
≤ 30 Days (n=5) 1
31 Days to ≤ 180 Days (n=27) 13
181 Days to ≤ 364 Days (n=19) 9
≥ 365 Days (n=168) 60
Unknown/Undescribed (n=1) 0
22.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=0) 0
Present (n=220) 83
23.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=206) 76
Present (n=14) 7
24.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
NRTIs (n=214 81
NNRTIs (n=9) 6
Integrase Inhibitors (n=11) 3
CCR5 Inhibitors (n=0) 0
25.Secondary Outcome
Title Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
Absent (n=104) 29
Present (n=116) 54
26.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 220
Measure Type: Number
Unit of Measure: participants
20
27.Secondary Outcome
Title Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation
Hide Description [Not Specified]
Time Frame Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Use Duration: 0 Months (n=6) 144.5  (130.9)
Use Duration: 3 Months (n=0) NA [1]   (NA)
Use Duration: 6 Months (n=1) 190.0 [2]   (NA)
Use Duration: 9 Months (n=0) NA [1]   (NA)
Use Duration: 12 Months (n=1) 104.0 [2]   (NA)
Use Duration: 24 Months (n=3) 184.3  (225.4)
Use Duration: 36 Months (n=2) 330.0  (200.8)
Use Duration: 48 Months (n=1) 474.0 [2]   (NA)
Use Duration: 60 Months (n=1) 377.0 [2]   (NA)
[1]
No data available for assessment.
[2]
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
28.Secondary Outcome
Title Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation
Hide Description [Not Specified]
Time Frame Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Use Duration: 0 Months (n=4) 654.5  (280.4)
Use Duration: 3 Months (n=1) 657.0 [1]   (NA)
Use Duration: 6 Months (n=1) 835.0 [1]   (NA)
Use Duration: 9 Months (n=2) 713.5  (82.7)
Use Duration: 12 Months (n=2) 878.5  (229.8)
Use Duration: 24 Months (n=0) NA [2]   (NA)
Use Duration: 36 Months (n=0) NA [2]   (NA)
Use Duration: 48 Months (n=0) NA [2]   (NA)
Use Duration: 60 Months (n=0) NA [2]   (NA)
[1]
Standard Deviation cannot be calculated as CD4 cell count is available for 1 subject only.
[2]
No data available for assessment.
29.Secondary Outcome
Title Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Use Duration: 0 Months (n=6) 5.2  (0.8)
Use Duration: 3 Months (n=0) NA [1]   (NA)
Use Duration: 6 Months (n=1) 2.6 [2]   (NA)
Use Duration: 9 Months (n=0) NA [1]   (NA)
Use Duration: 12 Months (n=1) 2.6 [2]   (NA)
Use Duration: 24 Months (n=3) 3.4  (1.3)
Use Duration: 36 Months (n=2) 2.6 [2]   (NA)
Use Duration: 48 Months (n=1) 2.6 [2]   (NA)
Use Duration: 60 Months (n=1) 2.6 [2]   (NA)
[1]
No data available for assessment.
[2]
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
30.Secondary Outcome
Title Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Use Duration: 0 Months (n=4) 2.6  (0.0)
Use Duration: 3 Months (n=1) 2.6 [1]   (NA)
Use Duration: 6 Months (n=1) 2.6 [1]   (NA)
Use Duration: 9 Months (n=2) 2.6  (0.0)
Use Duration: 12 Months (n=2) 2.6  (0.0)
Use Duration: 24 Months (n=0) NA [2]   (NA)
Use Duration: 36 Months (n=0) NA [2]   (NA)
Use Duration: 48 Months (n=0) NA [2]   (NA)
Use Duration: 60 Months (n=0) NA [2]   (NA)
[1]
Standard Deviation cannot be calculated as HIV-RNA value is available for 1 subject only.
[2]
No data available for assessment.
31.Secondary Outcome
Title Number of Participants in Each CDC Classification Category of HIV-infection Over Time
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Lopinavir/Ritonavir: Baseline CDC Category A Lopinavir/Ritonavir: Baseline CDC Category C Lopinavir/Ritonavir: Baseline CDC Category Unknown
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 9 5 206
Measure Type: Number
Unit of Measure: participants
CDC Category A After Treatment 4 0 39
CDC Category B After Treatment 0 0 9
CDC Category C After Treatment 0 3 36
CDC Category Unknown After Treatment 5 2 122
32.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
At 0 Months (n=6) 0.0
At 3 Months (n=0) NA [1] 
At 6 Months (n=1) 100.0
AT 9 Months (n=0) NA [1] 
At 12 Months (n=1) 100.0
At 24 Months (n=3) 66.7
At 36 Months (n=2) 100.0
At 48 Months (n=1) 100.0
At 60 Months (n=1) 100.0
[1]
No data available for assessment.
33.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description:
Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of participants
At 0 Months (n=4) 100.0
At 3 Months (n=1) 100.0
At 6 Months (n=1) 100.0
At 9 Months (n=2) 100.0
At 12 Months (n=2) 100.0
At 24 Months (n=0) NA [1] 
At 36 Months (n=0) NA [1] 
At 48 Months (n=0) NA [1] 
At 60 Months (n=0) NA [1] 
[1]
No data available for assessment.
Time Frame Up to 60 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lopinavir/Ritonavir
Hide Arm/Group Description Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
All-Cause Mortality
Lopinavir/Ritonavir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lopinavir/Ritonavir
Affected / at Risk (%)
Total   20/220 (9.09%) 
Cardiac disorders   
CARDIAC FAILURE * 1  1/220 (0.45%) 
Eye disorders   
CATARACT * 1  1/220 (0.45%) 
Gastrointestinal disorders   
INGUINAL HERNIA * 1  1/220 (0.45%) 
LARGE INTESTINE POLYP * 1  1/220 (0.45%) 
Hepatobiliary disorders   
BILIARY COLIC * 1  1/220 (0.45%) 
Immune system disorders   
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME * 1  1/220 (0.45%) 
Infections and infestations   
AMOEBIASIS * 1  1/220 (0.45%) 
CHRONIC HEPATITIS C * 1  1/220 (0.45%) 
LYMPH NODE TUBERCULOSIS * 1  1/220 (0.45%) 
PULMONARY TUBERCULOSIS * 1  1/220 (0.45%) 
MYCOBACTERIUM AVIUM COMPLEX INFECTION * 1  1/220 (0.45%) 
ENTERITIS INFECTIOUS * 1  1/220 (0.45%) 
HEPATITIS VIRUS-ASSOCIATED NEPHROPATHY * 1  1/220 (0.45%) 
HERPES ZOSTER MENINGITIS * 1  1/220 (0.45%) 
Musculoskeletal and connective tissue disorders   
OSTEONECROSIS * 1  2/220 (0.91%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ANAL CANCER * 1  1/220 (0.45%) 
HEPATIC CANCER * 1  1/220 (0.45%) 
Pregnancy, puerperium and perinatal conditions   
THREATENED LABOUR * 1  1/220 (0.45%) 
Renal and urinary disorders   
NEPHROLITHIASIS * 1  1/220 (0.45%) 
Respiratory, thoracic and mediastinal disorders   
PNEUMOTHORAX * 1  1/220 (0.45%) 
Surgical and medical procedures   
ABORTION INDUCED * 1  1/220 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lopinavir/Ritonavir
Affected / at Risk (%)
Total   99/220 (45.00%) 
Blood and lymphatic system disorders   
ANAEMIA * 1  2/220 (0.91%) 
Cardiac disorders   
CONGESTIVE CARDIOMYOPATHY * 1  1/220 (0.45%) 
Ear and labyrinth disorders   
DEAFNESS * 1  1/220 (0.45%) 
TINNITUS * 1  1/220 (0.45%) 
Endocrine disorders   
BASEDOW'S DISEASE * 1  1/220 (0.45%) 
HYPERTHYROIDISM * 1  1/220 (0.45%) 
Eye disorders   
CONJUNCTIVITIS ALLERGIC * 1  1/220 (0.45%) 
CORNEAL EROSION * 1  1/220 (0.45%) 
CHORIORETINOPATHY * 1  1/220 (0.45%) 
Gastrointestinal disorders   
ABDOMINAL PAIN * 1  1/220 (0.45%) 
CONSTIPATION * 1  1/220 (0.45%) 
DIARRHOEA * 1  9/220 (4.09%) 
GASTRITIS * 1  1/220 (0.45%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  2/220 (0.91%) 
NAUSEA * 1  1/220 (0.45%) 
General disorders   
PYREXIA * 1  1/220 (0.45%) 
Hepatobiliary disorders   
HEPATIC FUNCTION ABNORMAL * 1  4/220 (1.82%) 
HYPERBILIRUBINAEMIA * 1  1/220 (0.45%) 
LIVER DISORDER * 1  6/220 (2.73%) 
DRUG-INDUCED LIVER INJURY * 1  1/220 (0.45%) 
Infections and infestations   
SYPHILIS * 1  2/220 (0.91%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED * 1  1/220 (0.45%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/220 (0.45%) 
BETA 2 MICROGLOBULIN URINE INCREASED * 1  17/220 (7.73%) 
BLOOD BILIRUBIN INCREASED * 1  1/220 (0.45%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED * 1  1/220 (0.45%) 
BLOOD CREATININE INCREASED * 1  2/220 (0.91%) 
BLOOD TRIGLYCERIDES INCREASED * 1  13/220 (5.91%) 
BLOOD URIC ACID INCREASED * 1  3/220 (1.36%) 
C-REACTIVE PROTEIN INCREASED * 1  1/220 (0.45%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1  13/220 (5.91%) 
GLUCOSE URINE PRESENT * 1  1/220 (0.45%) 
HAEMOGLOBIN DECREASED * 1  1/220 (0.45%) 
LIPIDS ABNORMAL * 1  2/220 (0.91%) 
LOW DENSITY LIPOPROTEIN INCREASED * 1  1/220 (0.45%) 
RED BLOOD CELL COUNT DECREASED * 1  1/220 (0.45%) 
WHITE BLOOD CELL COUNT INCREASED * 1  1/220 (0.45%) 
PROTEIN URINE PRESENT * 1  2/220 (0.91%) 
TRANSAMINASES INCREASED * 1  1/220 (0.45%) 
BLOOD ALKALINE PHOSPHATASE INCREASED * 1  8/220 (3.64%) 
HEPATIC ENZYME INCREASED * 1  1/220 (0.45%) 
Metabolism and nutrition disorders   
DIABETES MELLITUS * 1  2/220 (0.91%) 
HYPERCHOLESTEROLAEMIA * 1  3/220 (1.36%) 
HYPERTRIGLYCERIDAEMIA * 1  22/220 (10.00%) 
HYPERURICAEMIA * 1  3/220 (1.36%) 
HYPOGLYCAEMIA * 1  1/220 (0.45%) 
DYSLIPIDAEMIA * 1  2/220 (0.91%) 
HYPERPHOSPHATASAEMIA * 1  4/220 (1.82%) 
LIPID METABOLISM DISORDER * 1  1/220 (0.45%) 
HYPERLIPIDAEMIA * 1  15/220 (6.82%) 
HYPO HDL CHOLESTEROLAEMIA * 1  1/220 (0.45%) 
Musculoskeletal and connective tissue disorders   
PAIN IN EXTREMITY * 1  1/220 (0.45%) 
POLYARTHRITIS * 1  1/220 (0.45%) 
OSTEOPENIA * 1  1/220 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
SKIN PAPILLOMA * 1  1/220 (0.45%) 
Nervous system disorders   
CERVICOBRACHIAL SYNDROME * 1  1/220 (0.45%) 
HEADACHE * 1  2/220 (0.91%) 
HYPOAESTHESIA * 1  1/220 (0.45%) 
SCIATICA * 1  1/220 (0.45%) 
Psychiatric disorders   
DEPRESSION * 1  5/220 (2.27%) 
INSOMNIA * 1  5/220 (2.27%) 
Renal and urinary disorders   
CALCULUS URETERIC * 1  1/220 (0.45%) 
CALCULUS URINARY * 1  1/220 (0.45%) 
NEPHROLITHIASIS * 1  1/220 (0.45%) 
RENAL DISORDER * 1  1/220 (0.45%) 
RENAL IMPAIRMENT * 1  5/220 (2.27%) 
Reproductive system and breast disorders   
GYNAECOMASTIA * 1  1/220 (0.45%) 
Respiratory, thoracic and mediastinal disorders   
ASTHMA * 1  2/220 (0.91%) 
RHINITIS ALLERGIC * 1  1/220 (0.45%) 
Skin and subcutaneous tissue disorders   
ACNE * 1  1/220 (0.45%) 
DERMATITIS * 1  1/220 (0.45%) 
PRURITUS * 1  1/220 (0.45%) 
RASH * 1  1/220 (0.45%) 
URTICARIA * 1  1/220 (0.45%) 
LIPODYSTROPHY ACQUIRED * 1  1/220 (0.45%) 
Vascular disorders   
HYPERTENSION * 1  2/220 (0.91%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: AbbVie Japan PMOS Desk
Organization: AbbVie (prior sponsor, Abbott)
Phone: +81-3-4577-1125
EMail: abvj-pmos@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01328158     History of Changes
Other Study ID Numbers: P12-760
First Submitted: April 1, 2011
First Posted: April 4, 2011
Results First Submitted: December 12, 2014
Results First Posted: December 22, 2014
Last Update Posted: December 22, 2014