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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerp
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Ghent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liege 1
Country [19] 0 0
Canada
State/province [19] 0 0
Calgary
Country [20] 0 0
Canada
State/province [20] 0 0
Hamilton
Country [21] 0 0
Canada
State/province [21] 0 0
Montreal
Country [22] 0 0
Canada
State/province [22] 0 0
Ottawa
Country [23] 0 0
Canada
State/province [23] 0 0
Ste-Foy
Country [24] 0 0
Canada
State/province [24] 0 0
Toronto
Country [25] 0 0
Canada
State/province [25] 0 0
Vancouver
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Brno
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Plzen
Country [28] 0 0
France
State/province [28] 0 0
Aix en Provence
Country [29] 0 0
France
State/province [29] 0 0
Besancon
Country [30] 0 0
France
State/province [30] 0 0
Lyon
Country [31] 0 0
France
State/province [31] 0 0
Montpellier Cedex 5
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Rennes
Country [34] 0 0
France
State/province [34] 0 0
Vandoeuvre les Nancy
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Bochum
Country [37] 0 0
Germany
State/province [37] 0 0
Bonn
Country [38] 0 0
Germany
State/province [38] 0 0
Cologne
Country [39] 0 0
Germany
State/province [39] 0 0
Frankfurt
Country [40] 0 0
Germany
State/province [40] 0 0
Fuerth
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Hannover
Country [43] 0 0
Greece
State/province [43] 0 0
Athens
Country [44] 0 0
Greece
State/province [44] 0 0
Thessaloniki
Country [45] 0 0
Ireland
State/province [45] 0 0
Dublin 7
Country [46] 0 0
Ireland
State/province [46] 0 0
Dublin 8
Country [47] 0 0
Italy
State/province [47] 0 0
Brescia
Country [48] 0 0
Italy
State/province [48] 0 0
Florence
Country [49] 0 0
Italy
State/province [49] 0 0
Genoa
Country [50] 0 0
Italy
State/province [50] 0 0
Milan
Country [51] 0 0
Italy
State/province [51] 0 0
Pavia
Country [52] 0 0
Italy
State/province [52] 0 0
Rome
Country [53] 0 0
Italy
State/province [53] 0 0
Turin
Country [54] 0 0
Netherlands
State/province [54] 0 0
Zwolle
Country [55] 0 0
Poland
State/province [55] 0 0
Chorzow
Country [56] 0 0
Poland
State/province [56] 0 0
Warsaw
Country [57] 0 0
Poland
State/province [57] 0 0
Wroclaw
Country [58] 0 0
Puerto Rico
State/province [58] 0 0
Ponce
Country [59] 0 0
Puerto Rico
State/province [59] 0 0
San Juan
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
Country [61] 0 0
Russian Federation
State/province [61] 0 0
St. Petersburg
Country [62] 0 0
Singapore
State/province [62] 0 0
Singapore
Country [63] 0 0
Spain
State/province [63] 0 0
A Coruna
Country [64] 0 0
Spain
State/province [64] 0 0
Alicante
Country [65] 0 0
Spain
State/province [65] 0 0
Barakaldo
Country [66] 0 0
Spain
State/province [66] 0 0
Barcelona
Country [67] 0 0
Spain
State/province [67] 0 0
Madrid
Country [68] 0 0
Spain
State/province [68] 0 0
Santander
Country [69] 0 0
Spain
State/province [69] 0 0
Santiago de Compostela
Country [70] 0 0
Spain
State/province [70] 0 0
Seville
Country [71] 0 0
Spain
State/province [71] 0 0
Valencia
Country [72] 0 0
Switzerland
State/province [72] 0 0
Basel
Country [73] 0 0
Switzerland
State/province [73] 0 0
Geneva 14
Country [74] 0 0
Switzerland
State/province [74] 0 0
Lausanne
Country [75] 0 0
Switzerland
State/province [75] 0 0
St. Gallen
Country [76] 0 0
Taiwan
State/province [76] 0 0
Taipei City
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Birmingham
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Brighton
Country [79] 0 0
United Kingdom
State/province [79] 0 0
London
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00262522