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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00098722




Registration number
NCT00098722
Ethics application status
Date submitted
7/12/2004
Date registered
8/12/2004
Date last updated
16/05/2012

Titles & IDs
Public title
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
Secondary ID [1] 0 0
A4001028
Universal Trial Number (UTN)
Trial acronym
MOTIVATE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 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 - Maraviroc (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - Maraviroc (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - optimized background therapy

Experimental: 1 -

Placebo comparator: 2 -

Experimental: 3 -


Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.

Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]

Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken twice daily

Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]

Treatment: Drugs: optimized background therapy
\[OBT (3-6 drugs based on treatment history and resistance testing)\]
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Primary outcome [3] 0 0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48
Timepoint [3] 0 0
Baseline and Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Timepoint [1] 0 0
Week 24 and 48
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
Timepoint [2] 0 0
Week 24 and 48
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
Timepoint [3] 0 0
Week 24 and 48
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Timepoint [4] 0 0
Week 24 and 48
Secondary outcome [5] 0 0
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Change From Baseline in CD4 Cell Count at Week 24 and 48
Timepoint [6] 0 0
Week 24 and 48
Secondary outcome [7] 0 0
Change From Baseline in CD8 Cell Count at Week 24 and 48
Timepoint [7] 0 0
Week 24 and 48
Secondary outcome [8] 0 0
Time to Virological Failure
Timepoint [8] 0 0
Week 48
Secondary outcome [9] 0 0
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
Timepoint [9] 0 0
Baseline to Week 24 and Week 48
Secondary outcome [10] 0 0
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Timepoint [10] 0 0
Screening
Secondary outcome [11] 0 0
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Timepoint [11] 0 0
Screening and time of failure through Week 24
Secondary outcome [12] 0 0
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48
Timepoint [12] 0 0
Screening and time of failure through Week 48
Secondary outcome [13] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Timepoint [13] 0 0
Baseline and time of failure through Week 24
Secondary outcome [14] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Timepoint [14] 0 0
Baseline and time of failure through Week 48
Secondary outcome [15] 0 0
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Timepoint [15] 0 0
Baseline, Week 24 and Week 48

Eligibility
Key inclusion criteria
* Men or women at least 16 yers of age (or minimum age as determined by local regulatory authorities)
* HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL
* Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks
* Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide
* Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure
* A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)
* Effective barrier contraception for WOCBP and males
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)
* Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days
* Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy
* Treatment for an active opportunistic infection, or unexplained temperature >38.5 degrees Celsius for 7 consecutive days
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up
* Lactating women, or planned pregnancy during the trial period
* Significant renal insufficiency
* Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 60 days prior to randomization or the expected need for such therapy during the study period
* Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization
* Significantly elevated liver enzymes or cirrhosis
* Significant neutropenia, anemia or thrombocytopenia
* Malabsorption or an inability to tolerate oral medications
* Certain medications
* Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial
* X4- or dual/mixed-tropic virus or repeated assay failure
* Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy

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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
474
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Burwood
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Surry Hills
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Sydney
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Wentworthville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Miami
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [9] 0 0
Pfizer Investigational Site - North Fitzroy
Recruitment hospital [10] 0 0
Pfizer Investigational Site - South Yarra
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Surry Hills
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4220 - Miami
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [10] 0 0
3141 - South Yarra
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Bp1412
Country [26] 0 0
France
State/province [26] 0 0
Cedex 02
Country [27] 0 0
France
State/province [27] 0 0
Cedex 09
Country [28] 0 0
France
State/province [28] 0 0
Cedex 10
Country [29] 0 0
France
State/province [29] 0 0
Cedex 12
Country [30] 0 0
France
State/province [30] 0 0
Cedex
Country [31] 0 0
France
State/province [31] 0 0
Le Kremlin Bicêtre
Country [32] 0 0
France
State/province [32] 0 0
Montpellier
Country [33] 0 0
France
State/province [33] 0 0
Nantes
Country [34] 0 0
France
State/province [34] 0 0
Nice Cedex 3, 06
Country [35] 0 0
France
State/province [35] 0 0
Paris, 75
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
Germany
State/province [37] 0 0
Aachen
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bochum
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Germany
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Bonn
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Germany
State/province [41] 0 0
Duesseldorf
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Germany
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Erlangen
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Germany
State/province [43] 0 0
Essen
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Germany
State/province [44] 0 0
Frankfurt
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
Country [46] 0 0
Germany
State/province [46] 0 0
Fuerth
Country [47] 0 0
Germany
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Hamburg
Country [48] 0 0
Germany
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Hannover
Country [49] 0 0
Germany
State/province [49] 0 0
Koeln
Country [50] 0 0
Germany
State/province [50] 0 0
Mannheim
Country [51] 0 0
Germany
State/province [51] 0 0
Muenchen
Country [52] 0 0
Germany
State/province [52] 0 0
Osnabrueck
Country [53] 0 0
Germany
State/province [53] 0 0
Stuttgart
Country [54] 0 0
Germany
State/province [54] 0 0
Ulm
Country [55] 0 0
Italy
State/province [55] 0 0
Antella (FI)
Country [56] 0 0
Italy
State/province [56] 0 0
Brescia
Country [57] 0 0
Italy
State/province [57] 0 0
Firenze
Country [58] 0 0
Italy
State/province [58] 0 0
Genova
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
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Modena
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Italy
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Monserrato, CA
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Italy
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Roma
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Italy
State/province [63] 0 0
Torino
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Italy
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Venezia
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Poland
State/province [69] 0 0
Bialystok
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Poland
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Bydgoszcz
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Chorzow
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Gdansk
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Poland
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Krakow
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Poland
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Szczecin
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Poland
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Warszawa
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Madrid
Country [80] 0 0
Spain
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San Sebastian
Country [81] 0 0
Spain
State/province [81] 0 0
Sevilla
Country [82] 0 0
Sweden
State/province [82] 0 0
Stockholm
Country [83] 0 0
Sweden
State/province [83] 0 0
Göteborg
Country [84] 0 0
Sweden
State/province [84] 0 0
Malmö
Country [85] 0 0
Switzerland
State/province [85] 0 0
Basel
Country [86] 0 0
Switzerland
State/province [86] 0 0
Genève
Country [87] 0 0
Switzerland
State/province [87] 0 0
Lausanne
Country [88] 0 0
Switzerland
State/province [88] 0 0
Lugano
Country [89] 0 0
Switzerland
State/province [89] 0 0
St. Gallen
Country [90] 0 0
Switzerland
State/province [90] 0 0
Zürich
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Leics
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Loth
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Birmingham
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Brighton
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Edinburgh
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Manchester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Newcastle Upon Tyre

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/NCT00098722