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Trial record 2 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

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ClinicalTrials.gov Identifier: NCT00262522
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : August 20, 2009
Last Update Posted : February 6, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus Infections
Intervention Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Enrollment 664
Recruitment Details Subjects were enrolled at 131 sites in 19 countries.
Pre-assignment Details Of the 672 subjects randomized, 8 discontinued from the study prior to receiving study drug due to withdrawal of consent (3), acute illness (2), lost to follow-up (1), other (1), and required prohibited medication (1).
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8)
Hide Arm/Group Description lopinavir/ritonavir 800/200 mg once daily (QD) tablet lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC) lopinavir/ritonavir 400/100 mg twice daily (BID) tablet lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Period Title: Study Start Through 8 Weeks
Started 167 166 166 165
Completed 163 161 155 160
Not Completed 4 5 11 5
Reason Not Completed
Adverse Event             1             2             3             1
Withdrawal by Subject             1             1             3             0
Lost to Follow-up             1             2             3             2
Noncompliance             0             0             2             2
Death             1             0             0             0
Period Title: Study Start Through 48 Weeks
Started 333 [1] 0 [2] 331 [1] 0 [3]
Completed 284 0 276 0
Not Completed 49 0 55 0
Reason Not Completed
Adverse Event             16             0             10             0
Withdrawal by Subject             10             0             11             0
Lost to Follow-up             8             0             14             0
Noncompliance             3             0             8             0
Death             2             0             1             0
Virologic failure             2             0             4             0
Relocated, Needed to take twice daily             8             0             7             0
[1]
Number of subjects who started the study, not the number who completed the first 8 weeks.
[2]
After Week 8, these subjects received the tablet formulation once daily through the end of study.
[3]
After Week 8, these subjects received the tablet formulation twice daily through the end of study.
Period Title: Study Start Through 96 Weeks
Started 333 [1] 0 [2] 331 [1] 0 [3]
Completed 256 0 254 0
Not Completed 77 0 77 0
Reason Not Completed
Adverse Event             20             0             16             0
Withdrawal by Subject             15             0             13             0
Lost to Follow-up             19             0             18             0
Noncompliance             6             0             11             0
Death             2             0             2             0
Virologic failure             5             0             8             0
Relocated, Needed to take twice daily             10             0             9             0
[1]
Number of subjects who started the study, not the number who completed the first 48 weeks.
[2]
After Week 8, these subjects received the tablet formulation once daily through the end of study.
[3]
After Week 8, these subjects received the tablet formulation twice daily through the end of study.
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8) Total
Hide Arm/Group Description lopinavir/ritonavir 800/200 mg once daily (QD) tablet lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC) lopinavir/ritonavir 400/100 mg twice daily (BID) tablet lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC) Total of all reporting groups
Overall Number of Baseline Participants 167 166 166 165 664
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 166 participants 166 participants 165 participants 664 participants
38.7  (9.80) 38.2  (9.63) 38.3  (9.69) 39.5  (10.31) 38.7  (9.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 166 participants 166 participants 165 participants 664 participants
Female
36
  21.6%
31
  18.7%
39
  23.5%
38
  23.0%
144
  21.7%
Male
131
  78.4%
135
  81.3%
127
  76.5%
127
  77.0%
520
  78.3%
CD4+ T Cell Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 167 participants 166 participants 166 participants 165 participants 664 participants
209.9  (125.10) 222.6  (127.37) 226.4  (136.64) 202.9  (139.57) 215.5  (132.34)
[1]
Measure Description: For once daily (QD) soft gel capsule (SGC), N=165.
Plasma HIV-1 RNA Level  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 167 participants 166 participants 166 participants 165 participants 664 participants
4.92  (0.64) 4.94  (0.67) 5.04  (0.68) 5.06  (0.64) 4.99  (0.66)
1.Primary Outcome
Title Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received at least 1 dose of study drug.
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8)
Hide Arm/Group Description:
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Overall Number of Participants Analyzed 167 166 166 165
Measure Type: Number
Unit of Measure: Percentage of Subjects
49.1 54.8 44.6 49.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r 800/200 mg QD Tablet, LPV/r 800/200 mg QD SGC (Through Week 8), LPV/r 400/100 mg BID Tablet, LPV/r 400/100 mg BID SGC (Through Week 8)
Comments Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.100
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8)
Hide Arm/Group Description:
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Overall Number of Participants Analyzed 333 0 331 0
Measure Type: Number
Unit of Measure: Percentage of Subjects
77.2 75.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
Comments The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.
Statistical Test of Hypothesis P-Value 0.715
Comments [Not Specified]
Method normal approx. to the binomial distr.
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects responding
Estimated Value 1.3
Confidence Interval 95%
-5.1 to 7.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame Week 96 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8)
Hide Arm/Group Description:
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Overall Number of Participants Analyzed 333 0 331 0
Measure Type: Number
Unit of Measure: Percentage of Subjects
64.9 69.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
Comments The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.
Statistical Test of Hypothesis P-Value 0.249
Comments [Not Specified]
Method normal approx. to the binomial distr.
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of subjects responding
Estimated Value -4.3
Confidence Interval 95%
-11.5 to 2.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Hide Description [Not Specified]
Time Frame Week 96 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who received at least 1 dose of study drug and who had CD4+ T cell counts available at both the Baseline Visit and Week 96.
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 800/200 mg QD SGC (Through Week 8) LPV/r 400/100 mg BID Tablet LPV/r 400/100 mg BID SGC (Through Week 8)
Hide Arm/Group Description:
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
Overall Number of Participants Analyzed 333 0 331 0
Mean (Standard Error)
Unit of Measure: cells/microliter
238.4  (10.02) 254.0  (10.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.269
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LPV/r 800/200 mg QD Tablet LPV/r 400/100 mg BID Tablet
Hide Arm/Group Description lopinavir/ritonavir 800/200 mg once daily (QD) tablet lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
All-Cause Mortality
LPV/r 800/200 mg QD Tablet LPV/r 400/100 mg BID Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LPV/r 800/200 mg QD Tablet LPV/r 400/100 mg BID Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   37/333 (11.11%)   50/331 (15.11%) 
Blood and lymphatic system disorders     
Anemia  1  1/333 (0.30%)  0/331 (0.00%) 
Febrile neutropenia  1  0/333 (0.00%)  1/331 (0.30%) 
Lymphadenopathy  1  0/333 (0.00%)  1/331 (0.30%) 
Lymphatic disorder  1  1/333 (0.30%)  0/331 (0.00%) 
Neutropenia  1  0/333 (0.00%)  2/331 (0.60%) 
Cardiac disorders     
Atrioventricular block  1  0/333 (0.00%)  1/331 (0.30%) 
Cardiac failure  1  0/333 (0.00%)  1/331 (0.30%) 
Palpitations  1  1/333 (0.30%)  0/331 (0.00%) 
Endocrine disorders     
Cushing's syndrome  1  1/333 (0.30%)  0/331 (0.00%) 
Hypothyroidism  1  1/333 (0.30%)  0/331 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/333 (0.00%)  1/331 (0.30%) 
Abdominal pain  1  0/333 (0.00%)  2/331 (0.60%) 
Appendicitis perforated  1  1/333 (0.30%)  0/331 (0.00%) 
Diarrhea  1  0/333 (0.00%)  1/331 (0.30%) 
Enterocolitis  1  1/333 (0.30%)  1/331 (0.30%) 
Food poisoning  1  0/333 (0.00%)  1/331 (0.30%) 
Gastrointestinal obstruction  1  0/333 (0.00%)  1/331 (0.30%) 
Inguinal hernia  1  1/333 (0.30%)  0/331 (0.00%) 
Intestinal obstruction  1  0/333 (0.00%)  1/331 (0.30%) 
Nausea  1  0/333 (0.00%)  2/331 (0.60%) 
Esophagitis  1  1/333 (0.30%)  0/331 (0.00%) 
Peritonitis  1  1/333 (0.30%)  0/331 (0.00%) 
Small intestinal obstruction  1  1/333 (0.30%)  0/331 (0.00%) 
Umbilical hernia  1  0/333 (0.00%)  1/331 (0.30%) 
General disorders     
Chills  1  0/333 (0.00%)  1/331 (0.30%) 
Death  1  0/333 (0.00%)  2/331 (0.60%) 
Malaise  1  0/333 (0.00%)  1/331 (0.30%) 
Pyrexia  1  2/333 (0.60%)  6/331 (1.81%) 
Hepatobiliary disorders     
Cholangitis  1  0/333 (0.00%)  1/331 (0.30%) 
Cholelithiasis  1  0/333 (0.00%)  1/331 (0.30%) 
Cytolytic hepatitis  1  1/333 (0.30%)  0/331 (0.00%) 
Immune system disorders     
Hypersensitivity  1  1/333 (0.30%)  0/331 (0.00%) 
Immune reconstitution syndrome  1  0/333 (0.00%)  1/331 (0.30%) 
Infections and infestations     
Abdominal infection  1  1/333 (0.30%)  0/331 (0.00%) 
Anogenital warts  1  0/333 (0.00%)  1/331 (0.30%) 
Appendicitis  1  1/333 (0.30%)  1/331 (0.30%) 
Bronchopneumonia  1  0/333 (0.00%)  1/331 (0.30%) 
Cellulitis  1  1/333 (0.30%)  1/331 (0.30%) 
Clostridium difficile colitis  1  0/333 (0.00%)  1/331 (0.30%) 
Gangrene  1  0/333 (0.00%)  1/331 (0.30%) 
Gastroenteritis  1  1/333 (0.30%)  1/331 (0.30%) 
Infected skin ulcer  1  0/333 (0.00%)  1/331 (0.30%) 
Influenza  1  1/333 (0.30%)  0/331 (0.00%) 
Lower respiratory tract infection  1  1/333 (0.30%)  0/331 (0.00%) 
Malaria  1  0/333 (0.00%)  1/331 (0.30%) 
Meningitis  1  1/333 (0.30%)  0/331 (0.00%) 
Meningitis tuberculous  1  1/333 (0.30%)  0/331 (0.00%) 
Perichondritis  1  1/333 (0.30%)  0/331 (0.00%) 
Pneumonia  1  2/333 (0.60%)  1/331 (0.30%) 
Pneumonia bacterial  1  0/333 (0.00%)  1/331 (0.30%) 
Pyelonephritis  1  0/333 (0.00%)  2/331 (0.60%) 
Rectal abscess  1  1/333 (0.30%)  0/331 (0.00%) 
Respiratory tract infection  1  2/333 (0.60%)  1/331 (0.30%) 
Sepsis  1  0/333 (0.00%)  1/331 (0.30%) 
Sinusitis  1  1/333 (0.30%)  0/331 (0.00%) 
Syphilis  1  1/333 (0.30%)  2/331 (0.60%) 
Typhoid fever  1  0/333 (0.00%)  1/331 (0.30%) 
Viral infection  1  0/333 (0.00%)  1/331 (0.30%) 
Injury, poisoning and procedural complications     
Anastomotic ulcer  1  0/333 (0.00%)  1/331 (0.30%) 
Back injury  1  0/333 (0.00%)  1/331 (0.30%) 
Facial bones fracture  1  1/333 (0.30%)  0/331 (0.00%) 
Meniscus lesion  1  0/333 (0.00%)  1/331 (0.30%) 
Traumatic fracture  1  1/333 (0.30%)  0/331 (0.00%) 
Investigations     
Blood urine present  1  0/333 (0.00%)  1/331 (0.30%) 
Creatinine renal clearance decreased  1  1/333 (0.30%)  0/331 (0.00%) 
Neutrophil count decreased  1  1/333 (0.30%)  0/331 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/333 (0.30%)  0/331 (0.00%) 
Dehydration  1  1/333 (0.30%)  2/331 (0.60%) 
Hypokalemia  1  0/333 (0.00%)  1/331 (0.30%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc degeneration  1  1/333 (0.30%)  0/331 (0.00%) 
Myalgia  1  0/333 (0.00%)  1/331 (0.30%) 
Rhabdomyolysis  1  0/333 (0.00%)  2/331 (0.60%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hepatic adenoma  1  0/333 (0.00%)  1/331 (0.30%) 
Non-Hodgkin's lymphoma  1  1/333 (0.30%)  0/331 (0.00%) 
Non-Hodgkin's lymphoma recurrent  1  1/333 (0.30%)  0/331 (0.00%) 
Squamous cell carcinoma  1  0/333 (0.00%)  1/331 (0.30%) 
Uterine leiomyoma  1  0/333 (0.00%)  1/331 (0.30%) 
Nervous system disorders     
Convulsion  1  1/333 (0.30%)  0/331 (0.00%) 
Dizziness  1  1/333 (0.30%)  1/331 (0.30%) 
Grand mal convulsion  1  0/333 (0.00%)  1/331 (0.30%) 
Loss of consciousness  1  0/333 (0.00%)  1/331 (0.30%) 
Reversible ischemic neurological deficit  1  0/333 (0.00%)  1/331 (0.30%) 
Subarachnoid hemorrhage  1  0/333 (0.00%)  1/331 (0.30%) 
Panic attack  1  0/333 (0.00%)  1/331 (0.30%) 
Psychotic disorder  1  0/333 (0.00%)  1/331 (0.30%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/333 (0.00%)  2/331 (0.60%) 
Blighted ovum  1  1/333 (0.30%)  0/331 (0.00%) 
Premature separation of placenta  1  0/333 (0.00%)  1/331 (0.30%) 
Depression  1  1/333 (0.30%)  1/331 (0.30%) 
Psychiatric disorders     
Drug dependence  1  1/333 (0.30%)  0/331 (0.00%) 
Suicide attempt  1  0/333 (0.00%)  1/331 (0.30%) 
Renal and urinary disorders     
Calculus ureteric  1  1/333 (0.30%)  0/331 (0.00%) 
Hydronephrosis  1  1/333 (0.30%)  0/331 (0.00%) 
Renal failure  1  0/333 (0.00%)  1/331 (0.30%) 
Renal failure acute  1  1/333 (0.30%)  0/331 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/333 (0.30%)  0/331 (0.00%) 
Dyspnea  1  1/333 (0.30%)  0/331 (0.00%) 
Pleuritic pain  1  1/333 (0.30%)  0/331 (0.00%) 
Pulmonary embolism  1  1/333 (0.30%)  1/331 (0.30%) 
Sinus congestion  1  1/333 (0.30%)  0/331 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/333 (0.00%)  1/331 (0.30%) 
Erythema multiform  1  1/333 (0.30%)  0/331 (0.00%) 
Granuloma skin  1  1/333 (0.30%)  0/331 (0.00%) 
Hyperhidrosis  1  0/333 (0.00%)  1/331 (0.30%) 
Idiopathic capillaritis  1  0/333 (0.00%)  1/331 (0.30%) 
Surgical and medical procedures     
Abortion induced  1  2/333 (0.60%)  4/331 (1.21%) 
Vascular disorders     
Deep vein thrombosis  1  0/333 (0.00%)  1/331 (0.30%) 
Hypotension  1  0/333 (0.00%)  1/331 (0.30%) 
Jugular vein thrombosis  1  0/333 (0.00%)  1/331 (0.30%) 
Subclavian vein thrombosis  1  0/333 (0.00%)  1/331 (0.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.9%
LPV/r 800/200 mg QD Tablet LPV/r 400/100 mg BID Tablet
Affected / at Risk (%) Affected / at Risk (%)
Total   292/333 (87.69%)   287/331 (86.71%) 
Gastrointestinal disorders     
Abdominal pain  1  26/333 (7.81%)  28/331 (8.46%) 
Abdominal pain upper  1  22/333 (6.61%)  16/331 (4.83%) 
Diarrhea  1  210/333 (63.06%)  197/331 (59.52%) 
Dyspepsia  1  21/333 (6.31%)  9/331 (2.72%) 
Flatulence  1  17/333 (5.11%)  27/331 (8.16%) 
Nausea  1  105/333 (31.53%)  84/331 (25.38%) 
Vomiting  1  46/333 (13.81%)  46/331 (13.90%) 
General disorders     
Asthenia  1  25/333 (7.51%)  18/331 (5.44%) 
Fatigue  1  45/333 (13.51%)  37/331 (11.18%) 
Influenza like illness  1  9/333 (2.70%)  19/331 (5.74%) 
Pyrexia  1  28/333 (8.41%)  29/331 (8.76%) 
Infections and infestations     
Bronchitis  1  29/333 (8.71%)  26/331 (7.85%) 
Gastroenteritis  1  9/333 (2.70%)  19/331 (5.74%) 
Influenza  1  28/333 (8.41%)  24/331 (7.25%) 
Nasopharyngitis  1  58/333 (17.42%)  61/331 (18.43%) 
Sinusitis  1  19/333 (5.71%)  17/331 (5.14%) 
Upper respiratory tract infection  1  29/333 (8.71%)  25/331 (7.55%) 
Metabolism and nutrition disorders     
Hypercholesterolemia  1  18/333 (5.41%)  19/331 (5.74%) 
Hypertriglyceridemia  1  18/333 (5.41%)  23/331 (6.95%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  21/333 (6.31%)  15/331 (4.53%) 
Nervous system disorders     
Dizziness  1  16/333 (4.80%)  17/331 (5.14%) 
Headache  1  44/333 (13.21%)  33/331 (9.97%) 
Psychiatric disorders     
Anxiety  1  13/333 (3.90%)  18/331 (5.44%) 
Depression  1  18/333 (5.41%)  19/331 (5.74%) 
Insomnia  1  24/333 (7.21%)  27/331 (8.16%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  32/333 (9.61%)  36/331 (10.88%) 
Pharyngolaryngeal pain  1  14/333 (4.20%)  21/331 (6.34%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  18/333 (5.41%)  14/331 (4.23%) 
Rash  1  27/333 (8.11%)  32/331 (9.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Provide ABBOTT at least thirty (30) days prior to submission for review, ABBOTT shall return comments within thirty (30) days of receipt of draft. Proposed draft shall be delayed an additional sixty (60) days in addition to the Review Period
Results Point of Contact
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Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00262522     History of Changes
Other Study ID Numbers: M05-730
2005-001430-32 ( EudraCT Number )
First Submitted: December 5, 2005
First Posted: December 7, 2005
Results First Submitted: July 9, 2009
Results First Posted: August 20, 2009
Last Update Posted: February 6, 2012