Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00358917
• Collaborator: (none)
• Enrollment: 599
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 22.2

Study Details

Study Description

Brief Summary

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Infections	Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs); Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 599 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LPV/r 800/200 mg QD Tablet	Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs); LPV/r 800/200 mg once-daily (QD) tablet; Other Names: ABT-378 lopinavir/ritonavir Kaletra
Active Comparator: LPV/r 400/100 mg BID Tablet	Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs); LPV/r 400/100 mg twice-daily (BID) tablet; Other Names: ABT-378 lopinavir/ritonavir Kaletra

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm [Week 48 (End of Study)]

   A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.

Secondary Outcome Measures

1. Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48 [Week 48 (End of Study)]

2. Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts [Week 48 (End of Study)]

3. Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir [Week 48 (End of Study)]

   Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.

4. Percentage of Participants With New Primary Protease Mutations at Week 48 [Week 48 (End of Study)]

   Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.

• Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening and were not acutely ill.

• Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy

• Female subjects were nonpregnant and nonlactating.

Exclusion Criteria:

• Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams per deciliter.

• Subjects were excluded if screening laboratory analyses showed absolute neutrophil count <= 750 cells/microliter.

• Subjects were excluded if screening laboratory analyses showed platelet count <= 50,000 per cubic millimeter.

• Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of normal (ULN).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Information - Abbott (1-800-633-9110)	Abbott Park	Illinois	United States	60064

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Thomas J Podsadecki, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00358917
• Other Study ID Numbers: M06-802
• First Posted: Aug 1, 2006
• Last Update Posted: Apr 11, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Ritonavir; Lopinavir; Reverse Transcriptase Inhibitors

Study Results

Participant Flow

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet	lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
Period Title: Overall Study
STARTED	300	299
COMPLETED	234	230
NOT COMPLETED	66	69

Baseline Characteristics

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet	Total
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet	Total of all reporting groups
Overall Participants	300	299	599
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (9.22)	40.8 (8.63)	40.6 (8.92)
Sex: Female, Male (Count of Participants)
Female	103 34.3%	103 34.4%	206 34.4%
Male	197 65.7%	196 65.6%	393 65.6%
Received Prior Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) (participants) [Number]
Received Prior NNRTI	264 88%	241 80.6%	505 84.3%
Did Not Receive Prior NNRTI	36 12%	58 19.4%	94 15.7%
Received Prior Nucleoside/nucleotide Reverse Transcriptase Inhibitor (NRTI) (participants) [Number]
Received Prior NRTI	299 99.7%	297 99.3%	596 99.5%
Did Not Receive Prior NRTI	1 0.3%	2 0.7%	3 0.5%
Received Prior Protease Inhibitor (PI) (participants) [Number]
Received Prior PI	140 46.7%	136 45.5%	276 46.1%
Did Not Receive Prior PI	160 53.3%	163 54.5%	323 53.9%
Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Count (cells/microliter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/microliter]	239.3 (158.39)	268.3 (183.55)	253.9 (171.98)
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level (log10 copies/milliliter (mL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [log10 copies/milliliter (mL)]	4.26 (0.826)	4.26 (0.809)	4.26 (0.817)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
Description	A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.
Time Frame	Week 48 (End of Study)

Outcome Measure Data

Analysis Population Description

Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Measure Participants	300	299
Number [Percentage of Participants]	55.3 18.4%	51.8 17.3%

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 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) 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 (once daily [QD] minus twice daily [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	0.413
	Comments
	Method	normal approx. to binomial distribution
	Comments
Method of Estimation	Estimation Parameter	Diff. in Percentage of Subj. Responding
	Estimated Value	3.5
	Confidence Interval	() 95%; -4.5 to 11.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48
Time Frame	Week 48 (End of Study)

Outcome Measure Data

Analysis Population Description

Observed data analysis using all available Week 48 data from all randomized participants who received at least 1 dose of study drug.

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Measure Participants	225	223
Number [Percentage of Participants]	76.0 25.3%	72.2 24.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.389
	Comments
	Method	normal approx. to binomial distribution
	Comments
Method of Estimation	Estimation Parameter	Diff. in Percentage of Subj. Responding
	Estimated Value	3.8
	Confidence Interval	() 95%; -4.3 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts
Time Frame	Week 48 (End of Study)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and who had CD4+ T cell counts at both the Baseline Visit and Week 48.

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Measure Participants	195	193
Mean (Standard Error) [cells/microliter]	135.3 (9.03)	121.5 (9.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.281
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir
Description	Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.
Time Frame	Week 48 (End of Study)

Outcome Measure Data

Analysis Population Description

Dropouts-as-censored: participants were responders if they had HIV-1 RNA <50 copies/mL at Week 48. Participants who discontinued (d/c'd) while suppressed or w/o post baseline (BL) levels were excluded. Those d/c'd <Day 85 were excluded unless they had >=1 post BL level & didn't achieve a decrease >=1.0 log10 copies/mL, then they were nonresponders.

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
Measure Participants	255	250
Number [Percentage of Participants]	65.5 21.8%	61.6 20.6%

5. Secondary Outcome

Title	Percentage of Participants With New Primary Protease Mutations at Week 48
Description	Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).
Time Frame	Week 48 (End of Study)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug and had post baseline genotypic resistance assay results.

Arm/Group Title	LPV/r 800/200 mg QD Tablet	LPV/r 400/100 mg BID Tablet
Arm/Group Description	lopinavir/ritonavir 800/200 mg once daily (QD) tablet	lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
Measure Participants	75	77
Number [Percentage of Participants]	8.0 2.7%	15.6 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LPV/r 800/200 mg QD Tablet, LPV/r 400/100 mg BID Tablet
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.222
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	LPV/r 800/200 mg QD Tablet		LPV/r 400/100 mg BID Tablet
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LPV/r 800/200 mg QD Tablet		LPV/r 400/100 mg BID Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/300 (9%)		37/299 (12.4%)
Blood and lymphatic system disorders
Anaemia	2/300 (0.7%)		0/299 (0%)
Leukocytosis	1/300 (0.3%)		0/299 (0%)
Lymphadenopathy	0/300 (0%)		1/299 (0.3%)
Cardiac disorders
Angina pectoris	1/300 (0.3%)		0/299 (0%)
Cardiac failure congestive	0/300 (0%)		1/299 (0.3%)
Cardiogenic shock	1/300 (0.3%)		0/299 (0%)
Tricuspid valve incompetence	1/300 (0.3%)		0/299 (0%)
Gastrointestinal disorders
Abdominal distension	0/300 (0%)		1/299 (0.3%)
Abdominal pain	1/300 (0.3%)		0/299 (0%)
Diarrhoea	1/300 (0.3%)		1/299 (0.3%)
Gastritis	1/300 (0.3%)		0/299 (0%)
Inguinal hernia	0/300 (0%)		1/299 (0.3%)
Nausea	2/300 (0.7%)		1/299 (0.3%)
Vomiting	1/300 (0.3%)		1/299 (0.3%)
General disorders
Asthenia	0/300 (0%)		1/299 (0.3%)
Chest pain	1/300 (0.3%)		1/299 (0.3%)
Chills	1/300 (0.3%)		0/299 (0%)
Death	0/300 (0%)		2/299 (0.7%)
Oedema peripheral	0/300 (0%)		1/299 (0.3%)
Pyrexia	2/300 (0.7%)		1/299 (0.3%)
Unevaluable event	0/300 (0%)		1/299 (0.3%)
Hepatobiliary disorders
Cholecystitis	1/300 (0.3%)		0/299 (0%)
Cholecystitis chronic	0/300 (0%)		1/299 (0.3%)
Jaundice	1/300 (0.3%)		0/299 (0%)
Immune system disorders
Drug hypersensitivity	0/300 (0%)		1/299 (0.3%)
Infections and infestations
Abscess limb	1/300 (0.3%)		0/299 (0%)
Appendicitis	0/300 (0%)		1/299 (0.3%)
Bacterial disease carrier	1/300 (0.3%)		0/299 (0%)
Bronchitis	0/300 (0%)		1/299 (0.3%)
Cellulitis	0/300 (0%)		1/299 (0.3%)
Cerebral toxoplasmosis	1/300 (0.3%)		0/299 (0%)
Cryptococcosis	1/300 (0.3%)		0/299 (0%)
Dengue fever	1/300 (0.3%)		0/299 (0%)
Disseminated tuberculosis	0/300 (0%)		1/299 (0.3%)
Gastroenteritis	1/300 (0.3%)		0/299 (0%)
Helicobacter infection	0/300 (0%)		1/299 (0.3%)
Herpes zoster	0/300 (0%)		1/299 (0.3%)
Meningitis	0/300 (0%)		1/299 (0.3%)
Meningitis tuberculous	1/300 (0.3%)		0/299 (0%)
Oral candidiasis	0/300 (0%)		1/299 (0.3%)
Pneumonia	3/300 (1%)		5/299 (1.7%)
Sepsis	1/300 (0.3%)		0/299 (0%)
Staphylococcal bacteraemia	0/300 (0%)		1/299 (0.3%)
Staphylococcal infection	1/300 (0.3%)		1/299 (0.3%)
Staphylococcal skin infection	0/300 (0%)		1/299 (0.3%)
Syphilis	1/300 (0.3%)		0/299 (0%)
Tuberculosis	1/300 (0.3%)		0/299 (0%)
Urinary tract infection	1/300 (0.3%)		0/299 (0%)
Injury, poisoning and procedural complications
Clavicle fracture	1/300 (0.3%)		0/299 (0%)
Head injury	0/300 (0%)		1/299 (0.3%)
Hip fracture	0/300 (0%)		1/299 (0.3%)
Injury	1/300 (0.3%)		0/299 (0%)
Lung injury	1/300 (0.3%)		0/299 (0%)
Rib fracture	1/300 (0.3%)		0/299 (0%)
Road traffic accident	1/300 (0.3%)		0/299 (0%)
Scapula fracture	1/300 (0.3%)		0/299 (0%)
Skin laceration	0/300 (0%)		1/299 (0.3%)
Upper limb fracture	0/300 (0%)		1/299 (0.3%)
Investigations
Haemoglobin decreased	0/300 (0%)		1/299 (0.3%)
Metabolism and nutrition disorders
Dehydration	1/300 (0.3%)		1/299 (0.3%)
Gout	1/300 (0.3%)		0/299 (0%)
Hyperlactacidaemia	0/300 (0%)		1/299 (0.3%)
Musculoskeletal and connective tissue disorders
Flank pain	1/300 (0.3%)		0/299 (0%)
Foot deformity	1/300 (0.3%)		0/299 (0%)
Lumbar spinal stenosis	0/300 (0%)		1/299 (0.3%)
Pain in extremity	0/300 (0%)		1/299 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular neoplasm	0/300 (0%)		1/299 (0.3%)
Nervous system disorders
Cerebral haemorrhage	0/300 (0%)		1/299 (0.3%)
Cerebral infarction	1/300 (0.3%)		0/299 (0%)
Cerebrovascular accident	0/300 (0%)		1/299 (0.3%)
Dizziness	0/300 (0%)		1/299 (0.3%)
Encephalitis	0/300 (0%)		1/299 (0.3%)
Mononeuritis	0/300 (0%)		1/299 (0.3%)
Paraesthesia	0/300 (0%)		1/299 (0.3%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	1/300 (0.3%)		0/299 (0%)
Ectopic pregnancy	0/300 (0%)		1/299 (0.3%)
Psychiatric disorders
Anxiety	1/300 (0.3%)		1/299 (0.3%)
Major depression	1/300 (0.3%)		0/299 (0%)
Personality disorder	0/300 (0%)		1/299 (0.3%)
Renal and urinary disorders
Acute prerenal failure	1/300 (0.3%)		0/299 (0%)
Choluria	1/300 (0.3%)		0/299 (0%)
Renal failure	1/300 (0.3%)		0/299 (0%)
Renal failure acute	0/300 (0%)		1/299 (0.3%)
Reproductive system and breast disorders
Cervical dysplasia	0/300 (0%)		1/299 (0.3%)
Epididymitis	1/300 (0.3%)		0/299 (0%)
Metrorrhagia	0/300 (0%)		1/299 (0.3%)
Vaginal dysplasia	0/300 (0%)		1/299 (0.3%)
Vaginal haemorrhage	1/300 (0.3%)		0/299 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/300 (0%)		1/299 (0.3%)
Chronic obstructive pulmonary disease	0/300 (0%)		2/299 (0.7%)
Dyspnoea	1/300 (0.3%)		0/299 (0%)
Haemothorax	1/300 (0.3%)		0/299 (0%)
Lung disorder	0/300 (0%)		1/299 (0.3%)
Pneumothorax	1/300 (0.3%)		0/299 (0%)
Pulmonary embolism	0/300 (0%)		1/299 (0.3%)
Pulmonary oedema	0/300 (0%)		1/299 (0.3%)
Respiratory failure	1/300 (0.3%)		0/299 (0%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/300 (0.3%)		0/299 (0%)
Stevens-Johnson syndrome	0/300 (0%)		1/299 (0.3%)
Vascular disorders
Arteriosclerosis	0/300 (0%)		1/299 (0.3%)
Deep vein thrombosis	0/300 (0%)		1/299 (0.3%)
Other (Not Including Serious) Adverse Events
	LPV/r 800/200 mg QD Tablet		LPV/r 400/100 mg BID Tablet
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	201/300 (67%)		180/299 (60.2%)
Gastrointestinal disorders
Abdominal pain	17/300 (5.7%)		8/299 (2.7%)
Diarrhoea	149/300 (49.7%)		115/299 (38.5%)
Nausea	47/300 (15.7%)		66/299 (22.1%)
Vomiting	36/300 (12%)		37/299 (12.4%)
Infections and infestations
Influenza	21/300 (7%)		19/299 (6.4%)
Nasopharyngitis	13/300 (4.3%)		16/299 (5.4%)
Upper respiratory tract infection	29/300 (9.7%)		26/299 (8.7%)
Nervous system disorders
Headache	20/300 (6.7%)		21/299 (7%)
Respiratory, thoracic and mediastinal disorders
Cough	15/300 (5%)		15/299 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

This study has varying agreements that have been negotiated individually; however, it appears that the most restrictive of the agreements states that following the first publication/presentation of the study by Abbott (or twelve [12] months after the completion of the study at all sites, whichever occurs first), the Principal Investigator (PI) shall, during a period of twelve (12) months, have the right to publish/present the results of the site.