Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Caps... | NCT00262522

NCT00262522

ID	Type	Description	Link
2005-001430-32	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
LPV/r 800/200 mg QD Tablet	Experimental	Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg QD SGC (Through Week 8)	Experimental	Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg BID Tablet	Active Comparator	Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg BID SGC (Through Week 8)	Active Comparator	Drug: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)	Drug	LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks		Week 8
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48		Week 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96		Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts		Week 96 (End of Study)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Daniel E Cohen, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 823		Phoenix	Arizona	85006	United States
Site Reference ID/Investigator# 846

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
FG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
BG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
BG002	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
BG003	LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038.7± 9.80 BG00138.2± 9.63 BG00238.3± 9.69 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00036 BG00131 BG002

CD4+ T Cell Count

For once daily (QD) soft gel capsule (SGC), N=165.

Mean

Standard Deviation

cells/mm3

Title

Denominators

Categories

Title	Measurements
	BG000209.9± 125.10 BG001222.6± 127.37

Plasma HIV-1 RNA Level

Mean

Standard Deviation

log10 copies/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.92± 0.64 BG0014.94± 0.67 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks

All randomized subjects who received at least 1 dose of study drug.

Posted

Number

Percentage of Subjects

Week 8

ID	Title	Description
OG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
OG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
OG002	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
OG003	LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Units	Counts
Participants	OG000167 OG001166 OG002166 OG003

Title

Denominators

Categories

Title	Measurements
	OG00049.1 OG00154.8 OG00244.6 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002 OG003	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.	Cochran-Mantel-Haenszel		>0.100							95						No	Superiority or Other

Primary

Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48

Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.

Posted

Number

Percentage of Subjects

Week 48

ID	Title	Description
OG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
OG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
OG002	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
OG003	LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Secondary

Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96

Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.

Posted

Number

Percentage of Subjects

Week 96 (End of Study)

ID	Title	Description
OG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
OG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
OG002	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
OG003	LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Secondary

Mean Change From Baseline to Week 96 in CD4+ T Cell Counts

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.

Posted

Mean

Standard Error

cells/microliter

Week 96 (End of Study)

ID	Title	Description
OG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet
OG001	LPV/r 800/200 mg QD SGC (Through Week 8)	lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
OG002	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
OG003	LPV/r 400/100 mg BID SGC (Through Week 8)	lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LPV/r 800/200 mg QD Tablet	lopinavir/ritonavir 800/200 mg once daily (QD) tablet			37	333	292	333
EG001	LPV/r 400/100 mg BID Tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet			50	331	287	331

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Lymphatic disorder	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Atrioventricular block	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Cardiac failure	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Palpitations	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Hypothyroidism	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Appendicitis perforated	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Esophagitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Chills	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Death	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Malaise	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected333 at risk EG0016 affected331 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Immune reconstitution syndrome	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Abdominal infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Anogenital warts	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Appendicitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Bronchopneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Gangrene	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Infected skin ulcer	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Malaria	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Meningitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Meningitis tuberculous	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Perichondritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected333 at risk EG0011 affected331 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Rectal abscess	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected333 at risk EG0011 affected331 at risk
Sepsis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Syphilis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0012 affected331 at risk
Typhoid fever	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Viral infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Blood urine present	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Creatinine renal clearance decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Neutrophil count decreased	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0012 affected331 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Hepatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Non-Hodgkin's lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Convulsion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Loss of consciousness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Reversible ischemic neurological deficit	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Subarachnoid hemorrhage	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0012 affected331 at risk
Blighted ovum	Pregnancy, puerperium and perinatal conditions	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Depression	Pregnancy, puerperium and perinatal conditions	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Drug dependence	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Panic attack	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Psychotic disorder	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Suicide attempt	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Renal failure	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0011 affected331 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Erythema multiform	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Granuloma skin	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected333 at risk EG0010 affected331 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Idiopathic capillaritis	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Abortion induced	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0002 affected333 at risk EG0014 affected331 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Hypotension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected333 at risk EG0011 affected331 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00026 affected333 at risk EG00128 affected331 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00022 affected333 at risk EG00116 affected331 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000210 affected333 at risk EG001197 affected331 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected333 at risk EG0019 affected331 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00017 affected333 at risk EG00127 affected331 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000105 affected333 at risk EG00184 affected331 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00046 affected333 at risk EG00146 affected331 at risk
Asthenia	General disorders	MedDRA 11.0	Systematic Assessment	EG00025 affected333 at risk EG00118 affected331 at risk
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG00045 affected333 at risk EG00137 affected331 at risk
Influenza like illness	General disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected333 at risk EG00119 affected331 at risk
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG00028 affected333 at risk EG00129 affected331 at risk
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00029 affected333 at risk EG00126 affected331 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 affected333 at risk EG00119 affected331 at risk
Influenza	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00028 affected333 at risk EG00124 affected331 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00058 affected333 at risk EG00161 affected331 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00019 affected333 at risk EG00117 affected331 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00029 affected333 at risk EG00125 affected331 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected333 at risk EG00119 affected331 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected333 at risk EG00123 affected331 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected333 at risk EG00115 affected331 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected333 at risk EG00117 affected331 at risk
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00044 affected333 at risk EG00133 affected331 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected333 at risk EG00118 affected331 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected333 at risk EG00119 affected331 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00024 affected333 at risk EG00127 affected331 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00032 affected333 at risk EG00136 affected331 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected333 at risk EG00121 affected331 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected333 at risk EG00114 affected331 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00027 affected333 at risk EG00132 affected331 at risk

ID	Term
D061466	Lopinavir
D019438	Ritonavir
D013607	Tablets
D002214	Capsules
C558899	lopinavir-ritonavir drug combination

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D004304	Dosage Forms
D004364	Pharmaceutical Preparations