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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01345630




Registration number
NCT01345630
Ethics application status
Date submitted
27/04/2011
Date registered
2/05/2011
Date last updated
14/01/2016

Titles & IDs
Public title
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
Scientific title
A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1
Secondary ID [1] 0 0
2010-021785-30
Secondary ID [2] 0 0
A4001095
Universal Trial Number (UTN)
Trial acronym
MODERN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Maraviroc
Treatment: Drugs - Emtricitabine/tenofovir
Treatment: Drugs - darunavir/ritonavir 800/100 mg
Treatment: Drugs - placebo for emtricitabine/tenofovir
Treatment: Drugs - placebo for maraviroc

Experimental: Maraviroc - Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.

Active comparator: Emtricitabine/tenofovir - Emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.


Treatment: Drugs: Maraviroc
Maraviroc tablet 150 mg once daily for 96 weeks.

Treatment: Drugs: Emtricitabine/tenofovir
Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.

Treatment: Drugs: darunavir/ritonavir 800/100 mg
darunavir/ritonavir 800/100 mg

Treatment: Drugs: placebo for emtricitabine/tenofovir
placebo for emtricitabine/tenofovir

Treatment: Drugs: placebo for maraviroc
placebo for maraviroc
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
Timepoint [1] 0 0
Week 48
Secondary outcome [1] 0 0
Frequency of Adverse Events (AE).
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Number of Participants With Grade 3 or 4 AEs
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
Number of Participants Who Discontinued Due to AEs
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Number of Treatment-related AEs
Timepoint [4] 0 0
Week 96
Secondary outcome [5] 0 0
Number of Participants With Treatment-emergent Serious Adverse Events
Timepoint [5] 0 0
Week 96
Secondary outcome [6] 0 0
Number of Participants With Abnormal Laboratory Values
Timepoint [6] 0 0
Week 96
Secondary outcome [7] 0 0
Severity of Abnormal Laboratory Values
Timepoint [7] 0 0
Week 96
Secondary outcome [8] 0 0
The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
Timepoint [8] 0 0
Week 48
Secondary outcome [9] 0 0
Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
Timepoint [9] 0 0
Week 48
Secondary outcome [10] 0 0
Tropism Change Between Screening or Baseline and PDTF
Timepoint [10] 0 0
Week 48
Secondary outcome [11] 0 0
Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
Timepoint [11] 0 0
Week 48
Secondary outcome [12] 0 0
Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
Timepoint [12] 0 0
Week 48
Secondary outcome [13] 0 0
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
Timepoint [13] 0 0
Baseline, Week 48
Secondary outcome [14] 0 0
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
Timepoint [14] 0 0
Baseline, Week 48
Secondary outcome [15] 0 0
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
Timepoint [15] 0 0
Baseline, Week 48
Secondary outcome [16] 0 0
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
Timepoint [16] 0 0
Baseline, Week 48
Secondary outcome [17] 0 0
Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
Timepoint [17] 0 0
Baseline, Week 48
Secondary outcome [18] 0 0
Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
Timepoint [18] 0 0
Week 48
Secondary outcome [19] 0 0
Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
Timepoint [19] 0 0
Week 48
Secondary outcome [20] 0 0
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
Timepoint [20] 0 0
Week 48
Secondary outcome [21] 0 0
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
Timepoint [21] 0 0
Week 48
Secondary outcome [22] 0 0
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
Timepoint [22] 0 0
Week 48
Secondary outcome [23] 0 0
Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
Timepoint [23] 0 0
Week 48
Secondary outcome [24] 0 0
Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
Timepoint [24] 0 0
Week 48

Eligibility
Key inclusion criteria
* Plasma HIV-1 RNA equal to or greater than 1,000 copies/mL measured at the Screening Visit.
* CD4 count equal to or greater than 100 cells/mm3 at Screening.
* Have only R5 HIV 1 at Screening as verified by a randomized tropism assay.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
* Any evidence of genotypic/phenotypic resistance to darunavir, tenofovir, and emtricitabine.
* CXCR4 using virus detected using randomized tropism determination or repeated failure to obtain an interpretable tropism result.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
813
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House General Practice - Darlinghurst
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Taylor Square Private Clinic - Surry Hills
Recruitment hospital [5] 0 0
Brisbane Sexual Health and HIV Service - Brisbane
Recruitment hospital [6] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment hospital [7] 0 0
Clinical Research Unit, Infectious Diseases - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Surry Hills
Recruitment postcode(s) [3] 0 0
4000 - Brisbane
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Wien
Country [23] 0 0
Belgium
State/province [23] 0 0
Antwerpen
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Bruxelles
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Liege
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Denmark
State/province [31] 0 0
Hvidovre
Country [32] 0 0
Denmark
State/province [32] 0 0
Koebenhavn OE
Country [33] 0 0
Denmark
State/province [33] 0 0
Odense
Country [34] 0 0
Finland
State/province [34] 0 0
Helsinki
Country [35] 0 0
France
State/province [35] 0 0
Cedex 02
Country [36] 0 0
France
State/province [36] 0 0
Cedex 12
Country [37] 0 0
France
State/province [37] 0 0
Cedex 18
Country [38] 0 0
France
State/province [38] 0 0
Bordeaux cedex
Country [39] 0 0
France
State/province [39] 0 0
Creteil
Country [40] 0 0
France
State/province [40] 0 0
Le Kremlin Bicetre
Country [41] 0 0
France
State/province [41] 0 0
LYON Cedex 4
Country [42] 0 0
France
State/province [42] 0 0
Montpellier
Country [43] 0 0
France
State/province [43] 0 0
Nantes
Country [44] 0 0
France
State/province [44] 0 0
Paris Cedex 10
Country [45] 0 0
France
State/province [45] 0 0
Paris
Country [46] 0 0
France
State/province [46] 0 0
Strasbourg Cedex
Country [47] 0 0
France
State/province [47] 0 0
Tourcoing
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Bonn
Country [50] 0 0
Germany
State/province [50] 0 0
Frankfurt am Main
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Koeln
Country [53] 0 0
Germany
State/province [53] 0 0
Muenchen
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Italy
State/province [55] 0 0
Milano
Country [56] 0 0
Netherlands
State/province [56] 0 0
Utrecht
Country [57] 0 0
Poland
State/province [57] 0 0
Bydgoszcz
Country [58] 0 0
Poland
State/province [58] 0 0
Warszawa
Country [59] 0 0
Poland
State/province [59] 0 0
Wroclaw
Country [60] 0 0
Portugal
State/province [60] 0 0
Amadora
Country [61] 0 0
Portugal
State/province [61] 0 0
Lisboa
Country [62] 0 0
Portugal
State/province [62] 0 0
Porto
Country [63] 0 0
Puerto Rico
State/province [63] 0 0
Bayamon
Country [64] 0 0
Puerto Rico
State/province [64] 0 0
Ponce
Country [65] 0 0
Puerto Rico
State/province [65] 0 0
Rio Piedras
Country [66] 0 0
Puerto Rico
State/province [66] 0 0
San Juan
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona
Country [68] 0 0
Spain
State/province [68] 0 0
Alicante
Country [69] 0 0
Spain
State/province [69] 0 0
Cordoba
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Spain
State/province [71] 0 0
Sevilla
Country [72] 0 0
Sweden
State/province [72] 0 0
Goteborg
Country [73] 0 0
Sweden
State/province [73] 0 0
Malmo
Country [74] 0 0
Sweden
State/province [74] 0 0
Stockholm
Country [75] 0 0
Switzerland
State/province [75] 0 0
Basel
Country [76] 0 0
Switzerland
State/province [76] 0 0
Bern
Country [77] 0 0
Switzerland
State/province [77] 0 0
St. Gallen
Country [78] 0 0
Switzerland
State/province [78] 0 0
Zurich
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Birmingham
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Brighton
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Edinburgh
Country [82] 0 0
United Kingdom
State/province [82] 0 0
London
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT01345630