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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00098293




Registration number
NCT00098293
Ethics application status
Date submitted
6/12/2004
Date registered
7/12/2004
Date last updated
9/10/2013

Titles & IDs
Public title
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
Scientific title
A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
Secondary ID [1] 0 0
A4001026
Universal Trial Number (UTN)
Trial acronym
MERIT
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 + Zidovudine/Lamivudine
Treatment: Drugs - Efavirenz + Zidovudine/Lamivudine
Treatment: Drugs - Maraviroc (UK-427,857) + Zidovudine/Lamivudine

Experimental: 1 -

Active comparator: 3 -

Experimental: 2 - Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz


Treatment: Drugs: Maraviroc + Zidovudine/Lamivudine
maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Treatment: Drugs: Efavirenz + Zidovudine/Lamivudine
efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)

Treatment: Drugs: Maraviroc (UK-427,857) + Zidovudine/Lamivudine
maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96
Timepoint [3] 0 0
Baseline, Week 48, Week 96
Secondary outcome [4] 0 0
Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels
Timepoint [4] 0 0
Baseline up to Week 48 and Week 96
Secondary outcome [5] 0 0
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96
Timepoint [5] 0 0
Baseline, Week 48, Week 96
Secondary outcome [6] 0 0
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96
Timepoint [6] 0 0
Baseline, Week 48, Week 96
Secondary outcome [7] 0 0
Time to Virologic Failure
Timepoint [7] 0 0
Week 48, Week 96
Secondary outcome [8] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Timepoint [8] 0 0
Baseline, time of failure through Week 48
Secondary outcome [9] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96
Timepoint [9] 0 0
Baseline, time of failure through Week 96
Secondary outcome [10] 0 0
Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96
Timepoint [10] 0 0
Screening, time of failure through Week 48, Week 96
Secondary outcome [11] 0 0
Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Timepoint [11] 0 0
Screening, time of failure through Week 48, Week 96
Secondary outcome [12] 0 0
Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96
Timepoint [12] 0 0
Screening, time of failure through Week 48, Week 96
Secondary outcome [13] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening
Timepoint [13] 0 0
Baseline, Week 48, Week 96

Eligibility
Key inclusion criteria
* Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)
* HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL
* 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
* 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
* Prior treatment with efavirenz, zidovudine or lamivudine or with any other antiretroviral therapy for more than 14 days at any time
* 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
* Suspected primary (acute) HIV-1 infection
* Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 30 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
* Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease
* Certain medications
* Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine
* 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 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
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
916
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 - Surrey Hills
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Wentworthville
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Miami
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [8] 0 0
Pfizer Investigational Site - North Fitzroy
Recruitment hospital [9] 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 - Surrey Hills
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4220 - Miami
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [9] 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
Colorado
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
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Argentina
State/province [20] 0 0
Provincia de Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Provincia de Neuquen
Country [22] 0 0
Argentina
State/province [22] 0 0
Buenos Aires
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad de Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Ciudad de Buenos
Country [25] 0 0
Argentina
State/province [25] 0 0
Provincia de Santa Fe
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Brazil
State/province [29] 0 0
RJ
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Manitoba
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Italy
State/province [36] 0 0
Antella (FI)
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Italy
State/province [38] 0 0
Milano
Country [39] 0 0
Italy
State/province [39] 0 0
Modena
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Italy
State/province [41] 0 0
Torino
Country [42] 0 0
Mexico
State/province [42] 0 0
Mexico City
Country [43] 0 0
Mexico
State/province [43] 0 0
Mexico D.F.
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Rotterdam
Country [46] 0 0
Netherlands
State/province [46] 0 0
Utrecht
Country [47] 0 0
Poland
State/province [47] 0 0
Bialystok
Country [48] 0 0
Poland
State/province [48] 0 0
Bydgoszcz
Country [49] 0 0
Poland
State/province [49] 0 0
Chorzow
Country [50] 0 0
Poland
State/province [50] 0 0
Gdansk
Country [51] 0 0
Poland
State/province [51] 0 0
Krakow
Country [52] 0 0
Poland
State/province [52] 0 0
Szczecin
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Puerto Rico
State/province [54] 0 0
Ponce
Country [55] 0 0
Puerto Rico
State/province [55] 0 0
Rio Piedras
Country [56] 0 0
Puerto Rico
State/province [56] 0 0
San Juan
Country [57] 0 0
South Africa
State/province [57] 0 0
Eastern Cape
Country [58] 0 0
South Africa
State/province [58] 0 0
Free State
Country [59] 0 0
South Africa
State/province [59] 0 0
Gauteng
Country [60] 0 0
South Africa
State/province [60] 0 0
KwaZulu Natal
Country [61] 0 0
South Africa
State/province [61] 0 0
Bloomfontein
Country [62] 0 0
South Africa
State/province [62] 0 0
Cape Town
Country [63] 0 0
South Africa
State/province [63] 0 0
Johannesburg
Country [64] 0 0
South Africa
State/province [64] 0 0
Pretoria North
Country [65] 0 0
South Africa
State/province [65] 0 0
Pretoria
Country [66] 0 0
South Africa
State/province [66] 0 0
Soweto, Johannesburg
Country [67] 0 0
Switzerland
State/province [67] 0 0
Basel
Country [68] 0 0
Switzerland
State/province [68] 0 0
Bern
Country [69] 0 0
Switzerland
State/province [69] 0 0
Genève
Country [70] 0 0
Switzerland
State/province [70] 0 0
Lugano
Country [71] 0 0
Switzerland
State/province [71] 0 0
St. Gallen
Country [72] 0 0
Switzerland
State/province [72] 0 0
Zürich
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Loth
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Birmingham
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Brighton
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Edinburgh
Country [77] 0 0
United Kingdom
State/province [77] 0 0
London
Country [78] 0 0
United Kingdom
State/province [78] 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/NCT00098293