Trial Outcomes & Findings for 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 (NCT NCT00262522)
NCT ID: NCT00262522
Last Updated: 2012-02-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
664 participants
Primary outcome timeframe
Week 8
Results posted on
2012-02-06
Participant Flow
Subjects were enrolled at 131 sites in 19 countries.
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).
Participant milestones
| Measure |
LPV/r 800/200 mg QD Tablet
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Study Start Through 8 Weeks
STARTED
|
167
|
166
|
166
|
165
|
|
Study Start Through 8 Weeks
COMPLETED
|
163
|
161
|
155
|
160
|
|
Study Start Through 8 Weeks
NOT COMPLETED
|
4
|
5
|
11
|
5
|
|
Study Start Through 48 Weeks
STARTED
|
333
|
0
|
331
|
0
|
|
Study Start Through 48 Weeks
COMPLETED
|
284
|
0
|
276
|
0
|
|
Study Start Through 48 Weeks
NOT COMPLETED
|
49
|
0
|
55
|
0
|
|
Study Start Through 96 Weeks
STARTED
|
333
|
0
|
331
|
0
|
|
Study Start Through 96 Weeks
COMPLETED
|
256
|
0
|
254
|
0
|
|
Study Start Through 96 Weeks
NOT COMPLETED
|
77
|
0
|
77
|
0
|
Reasons for withdrawal
| Measure |
LPV/r 800/200 mg QD Tablet
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Study Start Through 8 Weeks
Adverse Event
|
1
|
2
|
3
|
1
|
|
Study Start Through 8 Weeks
Withdrawal by Subject
|
1
|
1
|
3
|
0
|
|
Study Start Through 8 Weeks
Lost to Follow-up
|
1
|
2
|
3
|
2
|
|
Study Start Through 8 Weeks
Noncompliance
|
0
|
0
|
2
|
2
|
|
Study Start Through 8 Weeks
Death
|
1
|
0
|
0
|
0
|
|
Study Start Through 48 Weeks
Adverse Event
|
16
|
0
|
10
|
0
|
|
Study Start Through 48 Weeks
Withdrawal by Subject
|
10
|
0
|
11
|
0
|
|
Study Start Through 48 Weeks
Lost to Follow-up
|
8
|
0
|
14
|
0
|
|
Study Start Through 48 Weeks
Noncompliance
|
3
|
0
|
8
|
0
|
|
Study Start Through 48 Weeks
Death
|
2
|
0
|
1
|
0
|
|
Study Start Through 48 Weeks
Virologic failure
|
2
|
0
|
4
|
0
|
|
Study Start Through 48 Weeks
Relocated, Needed to take twice daily
|
8
|
0
|
7
|
0
|
|
Study Start Through 96 Weeks
Adverse Event
|
20
|
0
|
16
|
0
|
|
Study Start Through 96 Weeks
Withdrawal by Subject
|
15
|
0
|
13
|
0
|
|
Study Start Through 96 Weeks
Lost to Follow-up
|
19
|
0
|
18
|
0
|
|
Study Start Through 96 Weeks
Noncompliance
|
6
|
0
|
11
|
0
|
|
Study Start Through 96 Weeks
Death
|
2
|
0
|
2
|
0
|
|
Study Start Through 96 Weeks
Virologic failure
|
5
|
0
|
8
|
0
|
|
Study Start Through 96 Weeks
Relocated, Needed to take twice daily
|
10
|
0
|
9
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
LPV/r 800/200 mg QD Tablet
n=167 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
n=166 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
n=166 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
n=165 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
Total
n=664 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
38.7 years
STANDARD_DEVIATION 9.80 • n=93 Participants
|
38.2 years
STANDARD_DEVIATION 9.63 • n=4 Participants
|
38.3 years
STANDARD_DEVIATION 9.69 • n=27 Participants
|
39.5 years
STANDARD_DEVIATION 10.31 • n=483 Participants
|
38.7 years
STANDARD_DEVIATION 9.85 • n=36 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
144 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=93 Participants
|
135 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
127 Participants
n=483 Participants
|
520 Participants
n=36 Participants
|
|
CD4+ T Cell Count
|
209.9 cells/mm3
STANDARD_DEVIATION 125.10 • n=93 Participants
|
222.6 cells/mm3
STANDARD_DEVIATION 127.37 • n=4 Participants
|
226.4 cells/mm3
STANDARD_DEVIATION 136.64 • n=27 Participants
|
202.9 cells/mm3
STANDARD_DEVIATION 139.57 • n=483 Participants
|
215.5 cells/mm3
STANDARD_DEVIATION 132.34 • n=36 Participants
|
|
Plasma HIV-1 RNA Level
|
4.92 log10 copies/mL
STANDARD_DEVIATION 0.64 • n=93 Participants
|
4.94 log10 copies/mL
STANDARD_DEVIATION 0.67 • n=4 Participants
|
5.04 log10 copies/mL
STANDARD_DEVIATION 0.68 • n=27 Participants
|
5.06 log10 copies/mL
STANDARD_DEVIATION 0.64 • n=483 Participants
|
4.99 log10 copies/mL
STANDARD_DEVIATION 0.66 • n=36 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All randomized subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
LPV/r 800/200 mg QD Tablet
n=167 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
n=166 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
n=166 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
n=165 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
|
49.1 Percentage of Subjects
|
54.8 Percentage of Subjects
|
44.6 Percentage of Subjects
|
49.7 Percentage of Subjects
|
PRIMARY outcome
Timeframe: Week 48Population: Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
LPV/r 800/200 mg QD Tablet
n=333 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
n=331 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
|
77.2 Percentage of Subjects
|
—
|
75.8 Percentage of Subjects
|
—
|
SECONDARY outcome
Timeframe: Week 96 (End of Study)Population: Intent-to-treat noncompleters considered failures (ITT, NC=F); all randomized subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
LPV/r 800/200 mg QD Tablet
n=333 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
n=331 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
|
64.9 Percentage of Subjects
|
—
|
69.2 Percentage of Subjects
|
—
|
SECONDARY outcome
Timeframe: Week 96 (End of Study)Population: 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.
Outcome measures
| Measure |
LPV/r 800/200 mg QD Tablet
n=333 Participants
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 800/200 mg QD SGC (Through Week 8)
lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
|
LPV/r 400/100 mg BID Tablet
n=331 Participants
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
LPV/r 400/100 mg BID SGC (Through Week 8)
lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
|
|---|---|---|---|---|
|
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
|
238.4 cells/microliter
Standard Error 10.02
|
—
|
254.0 cells/microliter
Standard Error 10.00
|
—
|
Adverse Events
LPV/r 800/200 mg QD Tablet
Serious events: 37 serious events
Other events: 292 other events
Deaths: 0 deaths
LPV/r 400/100 mg BID Tablet
Serious events: 50 serious events
Other events: 287 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LPV/r 800/200 mg QD Tablet
n=333 participants at risk
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 400/100 mg BID Tablet
n=331 participants at risk
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.30%
1/333
|
0.00%
0/331
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/333
|
0.30%
1/331
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/333
|
0.30%
1/331
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.30%
1/333
|
0.00%
0/331
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/333
|
0.60%
2/331
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/333
|
0.30%
1/331
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/333
|
0.30%
1/331
|
|
Cardiac disorders
Palpitations
|
0.30%
1/333
|
0.00%
0/331
|
|
Endocrine disorders
Cushing's syndrome
|
0.30%
1/333
|
0.00%
0/331
|
|
Endocrine disorders
Hypothyroidism
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/333
|
0.60%
2/331
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Enterocolitis
|
0.30%
1/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/333
|
0.30%
1/331
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/333
|
0.60%
2/331
|
|
Gastrointestinal disorders
Esophagitis
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Peritonitis
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.30%
1/333
|
0.00%
0/331
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/333
|
0.30%
1/331
|
|
General disorders
Chills
|
0.00%
0/333
|
0.30%
1/331
|
|
General disorders
Death
|
0.00%
0/333
|
0.60%
2/331
|
|
General disorders
Malaise
|
0.00%
0/333
|
0.30%
1/331
|
|
General disorders
Pyrexia
|
0.60%
2/333
|
1.8%
6/331
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/333
|
0.30%
1/331
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/333
|
0.30%
1/331
|
|
Hepatobiliary disorders
Cytolytic hepatitis
|
0.30%
1/333
|
0.00%
0/331
|
|
Immune system disorders
Hypersensitivity
|
0.30%
1/333
|
0.00%
0/331
|
|
Immune system disorders
Immune reconstitution syndrome
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Abdominal infection
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Appendicitis
|
0.30%
1/333
|
0.30%
1/331
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Cellulitis
|
0.30%
1/333
|
0.30%
1/331
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Gangrene
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Gastroenteritis
|
0.30%
1/333
|
0.30%
1/331
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Influenza
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Lower respiratory tract infection
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Malaria
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Meningitis
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Meningitis tuberculous
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Perichondritis
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Pneumonia
|
0.60%
2/333
|
0.30%
1/331
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/333
|
0.60%
2/331
|
|
Infections and infestations
Rectal abscess
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Respiratory tract infection
|
0.60%
2/333
|
0.30%
1/331
|
|
Infections and infestations
Sepsis
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Sinusitis
|
0.30%
1/333
|
0.00%
0/331
|
|
Infections and infestations
Syphilis
|
0.30%
1/333
|
0.60%
2/331
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/333
|
0.30%
1/331
|
|
Infections and infestations
Viral infection
|
0.00%
0/333
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/333
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/333
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.30%
1/333
|
0.00%
0/331
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/333
|
0.30%
1/331
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.30%
1/333
|
0.00%
0/331
|
|
Investigations
Blood urine present
|
0.00%
0/333
|
0.30%
1/331
|
|
Investigations
Creatinine renal clearance decreased
|
0.30%
1/333
|
0.00%
0/331
|
|
Investigations
Neutrophil count decreased
|
0.30%
1/333
|
0.00%
0/331
|
|
Metabolism and nutrition disorders
Anorexia
|
0.30%
1/333
|
0.00%
0/331
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/333
|
0.60%
2/331
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/333
|
0.30%
1/331
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.30%
1/333
|
0.00%
0/331
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/333
|
0.30%
1/331
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/333
|
0.60%
2/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
0.00%
0/333
|
0.30%
1/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.30%
1/333
|
0.00%
0/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.30%
1/333
|
0.00%
0/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/333
|
0.30%
1/331
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/333
|
0.30%
1/331
|
|
Nervous system disorders
Convulsion
|
0.30%
1/333
|
0.00%
0/331
|
|
Nervous system disorders
Dizziness
|
0.30%
1/333
|
0.30%
1/331
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/333
|
0.30%
1/331
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/333
|
0.30%
1/331
|
|
Nervous system disorders
Reversible ischemic neurological deficit
|
0.00%
0/333
|
0.30%
1/331
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/333
|
0.30%
1/331
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/333
|
0.60%
2/331
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.30%
1/333
|
0.00%
0/331
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/333
|
0.30%
1/331
|
|
Pregnancy, puerperium and perinatal conditions
Depression
|
0.30%
1/333
|
0.30%
1/331
|
|
Psychiatric disorders
Drug dependence
|
0.30%
1/333
|
0.00%
0/331
|
|
Nervous system disorders
Panic attack
|
0.00%
0/333
|
0.30%
1/331
|
|
Nervous system disorders
Psychotic disorder
|
0.00%
0/333
|
0.30%
1/331
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/333
|
0.30%
1/331
|
|
Renal and urinary disorders
Calculus ureteric
|
0.30%
1/333
|
0.00%
0/331
|
|
Renal and urinary disorders
Hydronephrosis
|
0.30%
1/333
|
0.00%
0/331
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/333
|
0.30%
1/331
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/333
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/333
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.30%
1/333
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.30%
1/333
|
0.00%
0/331
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
1/333
|
0.30%
1/331
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.30%
1/333
|
0.00%
0/331
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/333
|
0.30%
1/331
|
|
Skin and subcutaneous tissue disorders
Erythema multiform
|
0.30%
1/333
|
0.00%
0/331
|
|
Skin and subcutaneous tissue disorders
Granuloma skin
|
0.30%
1/333
|
0.00%
0/331
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/333
|
0.30%
1/331
|
|
Skin and subcutaneous tissue disorders
Idiopathic capillaritis
|
0.00%
0/333
|
0.30%
1/331
|
|
Surgical and medical procedures
Abortion induced
|
0.60%
2/333
|
1.2%
4/331
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/333
|
0.30%
1/331
|
|
Vascular disorders
Hypotension
|
0.00%
0/333
|
0.30%
1/331
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/333
|
0.30%
1/331
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/333
|
0.30%
1/331
|
Other adverse events
| Measure |
LPV/r 800/200 mg QD Tablet
n=333 participants at risk
lopinavir/ritonavir 800/200 mg once daily (QD) tablet
|
LPV/r 400/100 mg BID Tablet
n=331 participants at risk
lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
26/333
|
8.5%
28/331
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
22/333
|
4.8%
16/331
|
|
Gastrointestinal disorders
Diarrhea
|
63.1%
210/333
|
59.5%
197/331
|
|
Gastrointestinal disorders
Dyspepsia
|
6.3%
21/333
|
2.7%
9/331
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
17/333
|
8.2%
27/331
|
|
Gastrointestinal disorders
Nausea
|
31.5%
105/333
|
25.4%
84/331
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
46/333
|
13.9%
46/331
|
|
General disorders
Asthenia
|
7.5%
25/333
|
5.4%
18/331
|
|
General disorders
Fatigue
|
13.5%
45/333
|
11.2%
37/331
|
|
General disorders
Influenza like illness
|
2.7%
9/333
|
5.7%
19/331
|
|
General disorders
Pyrexia
|
8.4%
28/333
|
8.8%
29/331
|
|
Infections and infestations
Bronchitis
|
8.7%
29/333
|
7.9%
26/331
|
|
Infections and infestations
Gastroenteritis
|
2.7%
9/333
|
5.7%
19/331
|
|
Infections and infestations
Influenza
|
8.4%
28/333
|
7.3%
24/331
|
|
Infections and infestations
Nasopharyngitis
|
17.4%
58/333
|
18.4%
61/331
|
|
Infections and infestations
Sinusitis
|
5.7%
19/333
|
5.1%
17/331
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
29/333
|
7.6%
25/331
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
5.4%
18/333
|
5.7%
19/331
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.4%
18/333
|
6.9%
23/331
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
21/333
|
4.5%
15/331
|
|
Nervous system disorders
Dizziness
|
4.8%
16/333
|
5.1%
17/331
|
|
Nervous system disorders
Headache
|
13.2%
44/333
|
10.0%
33/331
|
|
Psychiatric disorders
Anxiety
|
3.9%
13/333
|
5.4%
18/331
|
|
Psychiatric disorders
Depression
|
5.4%
18/333
|
5.7%
19/331
|
|
Psychiatric disorders
Insomnia
|
7.2%
24/333
|
8.2%
27/331
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
32/333
|
10.9%
36/331
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
14/333
|
6.3%
21/331
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
18/333
|
4.2%
14/331
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.1%
27/333
|
9.7%
32/331
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER