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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00262522




Registration number
NCT00262522
Ethics application status
Date submitted
5/12/2005
Date registered
7/12/2005
Date last updated
6/02/2012

Titles & IDs
Public title
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
Scientific title
A Phase 3, Randomized, Open-label, Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With NRTIs in Antiretroviral Naive HIV-1 Infected Subjects
Secondary ID [1] 0 0
2005-001430-32
Secondary ID [2] 0 0
M05-730
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Treatment: Drugs - lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Treatment: Drugs - lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
Treatment: Drugs - lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)

Experimental: LPV/r 800/200 mg QD Tablet -

Experimental: LPV/r 800/200 mg QD SGC (Through Week 8) -

Active Comparator: LPV/r 400/100 mg BID Tablet -

Active Comparator: LPV/r 400/100 mg BID SGC (Through Week 8) -


Treatment: Drugs: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD

Treatment: Drugs: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD

Treatment: Drugs: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD

Treatment: Drugs: lopinavir/ritonavir (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Timepoint [1] 0 0
Week 8
Primary outcome [2] 0 0
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Timepoint [1] 0 0
Week 96 (End of Study)
Secondary outcome [2] 0 0
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Timepoint [2] 0 0
Week 96 (End of Study)

Eligibility
Key inclusion criteria
Inclusion Criteria

- Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral
naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy.

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

- Female subjects were nonpregnant and nonlactating.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

- Subjects were excluded if screening laboratory analyses showed any of the following
abnormal laboratory results:

- Presence of hepatitis B surface antigen (HBsAg)

- Hemoglobin <= 8.0 g/dL

- Absolute neutrophil count <= 750 cells/microliter

- Platelet count <= 50,000 per mL

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper
Limit of Normal (ULN)

- Calculated creatinine clearance < 50 mL/min

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
664
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 244 - Darlinghurst
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 245 - Melbourne
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 246 - South Yarra
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3141 - South Yarra
Recruitment outside Australia
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United States of America
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Arizona
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California
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District of Columbia
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Florida
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Georgia
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Illinois
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Kansas
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Minnesota
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Missouri
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New York
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North Carolina
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Texas
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Virginia
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Belgium
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Antwerp
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Belgium
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Brussels
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Belgium
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Ghent
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Belgium
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Leuven
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Belgium
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Liege 1
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Canada
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Calgary
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Canada
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Hamilton
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Canada
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Montreal
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Canada
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Ottawa
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Canada
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Ste-Foy
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Canada
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Toronto
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Canada
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Vancouver
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Czech Republic
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Brno
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Czech Republic
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Plzen
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France
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Aix en Provence
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France
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Besancon
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France
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Lyon
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France
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Montpellier Cedex 5
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France
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Paris
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France
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Rennes
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France
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Vandoeuvre les Nancy
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Cologne
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Germany
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Frankfurt
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Germany
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Fuerth
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Germany
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Hamburg
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Germany
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Hannover
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Greece
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Athens
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Greece
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Thessaloniki
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Ireland
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Dublin 7
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Ireland
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Dublin 8
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Italy
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Brescia
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Italy
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Florence
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Italy
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Genoa
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Italy
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Milan
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Italy
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Pavia
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Italy
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Rome
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Italy
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Turin
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Netherlands
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Zwolle
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Poland
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Chorzow
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Poland
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Warsaw
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Wroclaw
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Spain
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A Coruna
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Spain
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Alicante
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Barakaldo
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Barcelona
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Madrid
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Santander
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Spain
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Santiago de Compostela
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Spain
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Seville
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Spain
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Valencia
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Switzerland
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Basel
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Switzerland
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Geneva 14
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Switzerland
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Lausanne
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Switzerland
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St. Gallen
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Taiwan
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Taipei City
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United Kingdom
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Birmingham
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United Kingdom
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Brighton
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study was to compare the safety and tolerability of the to-be-marketed
lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC)
formulation and to compare the safety, tolerability, and antiviral activity of once daily
(QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select
nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously
received antiretroviral treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00262522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel E Cohen, MD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00262522