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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 (MOTIVATE 2)

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Maraviroc (UK-427,857)

optimized background therapy

Maraviroc (UK-427,857)

optimized background therapy

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline

Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24

Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48

Secondary Outcome Measures

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline

Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline

Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Change From Baseline in CD4 Cell Count at Week 24 and 48

Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Change From Baseline in CD8 Cell Count at Week 24 and 48

Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Time to Virological Failure

Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.

Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels

TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening

Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24

Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48

Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24

Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48

Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.

Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening

Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.

Full Information

NCT ID

NCT00098722

First Posted

December 7, 2004

Last Updated

April 16, 2012

Sponsor

ViiV Healthcare

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00098722

Brief 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

Acronym

MOTIVATE 2

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

474 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

optimized background therapy

Other Intervention Name(s)

Selzentry

Intervention Description

[OBT (3-6 drugs based on treatment history and resistance testing)]

Intervention Type

Drug

Intervention Name(s)

Maraviroc (UK-427,857)

Other Intervention Name(s)

Selzentry

Intervention Description

maraviroc (UK-427,857) 150 mg taken twice daily

Intervention Type

Drug

Intervention Name(s)

optimized background therapy

Intervention Description

[OBT (3-6 drugs based on treatment history and resistance testing)]

Intervention Type

Drug

Intervention Name(s)

optimized background therapy

Intervention Description

[OBT (3-6 drugs based on treatment history and resistance testing)]

Primary Outcome Measure Information:

Title

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline

Description

Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.

Time Frame

Baseline

Title

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48

Description

Time Frame

Baseline and Week 48

Secondary Outcome Measure Information:

Title

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL

Time Frame

Week 24 and 48

Title

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline

Time Frame

Week 24 and 48

Title

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline

Time Frame

Week 24 and 48

Title

Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Time Frame

Week 24 and 48

Title

Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline

Description

Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Time Frame

Baseline

Title

Change From Baseline in CD4 Cell Count at Week 24 and 48

Description

Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Time Frame

Week 24 and 48

Title

Change From Baseline in CD8 Cell Count at Week 24 and 48

Description

Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.

Time Frame

Week 24 and 48

Title

Time to Virological Failure

Description

Time Frame

Week 48

Title

Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels

Description

Time Frame

Baseline to Week 24 and Week 48

Title

Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening

Description

Time Frame

Screening

Title

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24

Description

Time Frame

Screening and time of failure through Week 24

Title

Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48

Description

Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.

Time Frame

Screening and time of failure through Week 48

Title

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24

Description

Time Frame

Baseline and time of failure through Week 24

Title

Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48

Description

Time Frame

Baseline and time of failure through Week 48

Title

Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening

Description

Time Frame

Baseline, Week 24 and Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Hobson City

State/Province

Alabama

ZIP/Postal Code

36201

Country

United States

Facility Name

Pfizer Investigational Site

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Pfizer Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Pfizer Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94609-3480

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Pfizer Investigational Site

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Pfizer Investigational Site

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06851

Country

United States

Facility Name

Pfizer Investigational Site

City

Southport

State/Province

Connecticut

ZIP/Postal Code

06490

Country

United States

Facility Name

Pfizer Investigational Site

City

Stratford

State/Province

Connecticut

ZIP/Postal Code

06614

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Pfizer Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010-2976

Country

United States

Facility Name

Pfizer Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Pfizer Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021-6327

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33139

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33145

Country

United States

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Pfizer Investigational Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

Pfizer Investigational Site

City

Safety Harbor

State/Province

Florida

ZIP/Postal Code

34695

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33611

Country

United States

Facility Name

Pfizer Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318-2513

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30339-3915

Country

United States

Facility Name

Pfizer Investigational Site

City

Jonesboro

State/Province

Georgia

ZIP/Postal Code

30236

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60613

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

Pfizer Investigational Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Pfizer Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Pfizer Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Pfizer Investigational Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

20910

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0008

Country

United States

Facility Name

Pfizer Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0352

Country

United States

Facility Name

Pfizer Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Pfizer Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Pfizer Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64106

Country

United States

Facility Name

Pfizer Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63139-2909

Country

United States

Facility Name

Pfizer Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Pfizer Investigational Site

City

East Meadow

State/Province

New York

ZIP/Postal Code

11554

Country

United States

Facility Name

Pfizer Investigational Site

City

Elmira

State/Province

New York

ZIP/Postal Code

14905

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10011

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Facility Name

Pfizer Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Pfizer Investigational Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Pfizer Investigational Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44304

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Pfizer Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Pfizer Investigational Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Facility Name

Pfizer Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Pfizer Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75219

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Pfizer Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Pfizer Investigational Site

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77505-4245

Country

United States

Facility Name

Pfizer Investigational Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Pfizer Investigational Site

City

Hampton

State/Province

Virginia

ZIP/Postal Code

23666

Country

United States

Facility Name

Pfizer Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Pfizer Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Pfizer Investigational Site

City

Burwood

State/Province

New South Wales

ZIP/Postal Code

2134

Country

Australia

Facility Name

Pfizer Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Surry Hills

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Wentworthville

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Pfizer Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Pfizer Investigational Site

City

Miami

State/Province

Queensland

ZIP/Postal Code

4220

Country

Australia

Facility Name

Pfizer Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Pfizer Investigational Site

City

North Fitzroy

State/Province

Victoria

ZIP/Postal Code

3068

Country

Australia

Facility Name

Pfizer Investigational Site

City

South Yarra

State/Province

Victoria

ZIP/Postal Code

3141

Country

Australia

Facility Name

Pfizer Investigational Site

City

Darlinghurst

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 2W5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toulon

State/Province

Bp1412

ZIP/Postal Code

83056

Country

France

Facility Name

Pfizer Investigational Site

City

Lyon

State/Province

Cedex 02

ZIP/Postal Code

69288

Country

France

Facility Name

Pfizer Investigational Site

City

Orleans

State/Province

Cedex 02

ZIP/Postal Code

45067

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille

State/Province

Cedex 09

ZIP/Postal Code

13274

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

State/Province

Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

State/Province

Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Pfizer Investigational Site

City

Bobigny

State/Province

Cedex

ZIP/Postal Code

93009

Country

France

Facility Name

Pfizer Investigational Site

City

Caen

State/Province

Cedex

ZIP/Postal Code

14033

Country

France

Facility Name

Pfizer Investigational Site

City

Le Kremlin Bicêtre

ZIP/Postal Code

94270

Country

France

Facility Name

Pfizer Investigational Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Pfizer Investigational Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Pfizer Investigational Site

City

Nice Cedex 3, 06

ZIP/Postal Code

06202

Country

France

Facility Name

Pfizer Investigational Site

City

Paris, 75

ZIP/Postal Code

75020

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Pfizer Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Pfizer Investigational Site

City

Aachen

ZIP/Postal Code

52062

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Pfizer Investigational Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Pfizer Investigational Site

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Pfizer Investigational Site

City

Freiburg

ZIP/Postal Code

79098

Country

Germany

Facility Name

Pfizer Investigational Site

City

Fuerth

ZIP/Postal Code

90762

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Pfizer Investigational Site

City

Koeln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mannheim

ZIP/Postal Code

68161

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Pfizer Investigational Site

City

Osnabrueck

ZIP/Postal Code

49090

Country

Germany

Facility Name

Pfizer Investigational Site

City

Stuttgart

ZIP/Postal Code

70197

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Pfizer Investigational Site

City

Antella (FI)

ZIP/Postal Code

50011

Country

Italy

Facility Name

Pfizer Investigational Site

City

Brescia

ZIP/Postal Code

25123

Country

Italy

Facility Name

Pfizer Investigational Site

City

Firenze

ZIP/Postal Code

50193

Country

Italy

Facility Name

Pfizer Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Monserrato, CA

ZIP/Postal Code

09042

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00184

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00185

Country

Italy

Facility Name

Pfizer Investigational Site

City

Torino

ZIP/Postal Code

10149

Country

Italy

Facility Name

Pfizer Investigational Site

City

Venezia

ZIP/Postal Code

30170

Country

Italy

Facility Name

Pfizer Investigational Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-030

Country

Poland

Facility Name

Pfizer Investigational Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-531

Country

Poland

Facility Name

Pfizer Investigational Site

City

Szczecin

ZIP/Postal Code

71-455

Country

Poland

Facility Name

Pfizer Investigational Site

City

Warszawa

ZIP/Postal Code

01-201

Country

Poland

Facility Name

Pfizer Investigational Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03202

Country

Spain

Facility Name

Pfizer Investigational Site

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Pfizer Investigational Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Pfizer Investigational Site

City

San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Pfizer Investigational Site

City

Venhalsan

State/Province

Stockholm

ZIP/Postal Code

118 83

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Göteborg

ZIP/Postal Code

41685

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Malmö

ZIP/Postal Code

214 01

Country

Sweden

Facility Name

Pfizer Investigational Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Genève

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Lugano

ZIP/Postal Code

6900

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Leicester

State/Province

Leics

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Edinburgh

State/Province

Loth

ZIP/Postal Code

ED4 2XU

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Brighton

ZIP/Postal Code

BN2 1ES

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SW10 9TH

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Manchester

ZIP/Postal Code

M8 5RB

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Newcastle Upon Tyre

ZIP/Postal Code

NE4 6BE

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

34343443

Citation

Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.

Results Reference

derived

PubMed Identifier

24419064

Citation

Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

Results Reference

derived

PubMed Identifier

20703158

Citation

Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.

Results Reference

derived

PubMed Identifier

18832245

Citation

Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.

Results Reference

derived

PubMed Identifier

18832244

Citation

Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001028&StudyName=Trial%20of%20Maraviroc%20%28UK-427%2C857%29%20in%20Combination%20with%20Optimized%20Background%20Therapy%20Versus%20Optimized%20Background%20Therapy%20Alone%20for%20the%20Tre

Description

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Learn more about this trial

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

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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 (MOTIVATE 2)

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial