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HIV InfectionsPhase 2/3MOTIVATE 2NCT00098722

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

A Phase 2/3 study testing Maraviroc (UK-427,857) and optimized background therapy in people with HIV Infections, run by ViiV Healthcare at 172 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
Maraviroc (UK-427,857) and optimized background therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
474 participants
Where
172 sitesin 13 countries
Study dates
Dec 2004to Apr 2011
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

172 sites in 13 countries.

172 sites in 13 countries

United States62 sites

  • Pfizer Investigational Site

    Akron, Ohio, 44304

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48109-0008

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48109-0352

  • Pfizer Investigational Site

    Atlanta, Georgia, 30309

  • Pfizer Investigational Site

    Atlanta, Georgia, 30318-2513

  • Pfizer Investigational Site

    Atlanta, Georgia, 30339-3915

  • Pfizer Investigational Site

    Baltimore, Maryland, 21201

  • Pfizer Investigational Site

    Buffalo, New York, 14215

  • Pfizer Investigational Site

    Charleston, South Carolina, 29403

  • Pfizer Investigational Site

    Charleston, South Carolina, 29425

  • Pfizer Investigational Site

    Chicago, Illinois, 60613

  • Pfizer Investigational Site

    Chicago, Illinois, 60657

  • Pfizer Investigational Site

    Clearwater, Florida, 33765

  • Pfizer Investigational Site

    Cleveland, Ohio, 44109

  • Pfizer Investigational Site

    Dallas, Texas, 75219

  • Pfizer Investigational Site

    Danville, Virginia, 24541

  • Pfizer Investigational Site

    Detroit, Michigan, 48201

  • Pfizer Investigational Site

    Detroit, Michigan, 48202

  • Pfizer Investigational Site

    East Meadow, New York, 11554

  • Pfizer Investigational Site

    Elmira, New York, 14905

  • Pfizer Investigational Site

    Fort Worth, Texas, 76104

  • Pfizer Investigational Site

    Fort Worth, Texas, 76107

  • Pfizer Investigational Site

    Garden Grove, California, 92845

  • Pfizer Investigational Site

    Greenville, North Carolina, 27834

  • Pfizer Investigational Site

    Hampton, Virginia, 23666

  • Pfizer Investigational Site

    Hobson City, Alabama, 36201

  • Pfizer Investigational Site

    Hollywood, Florida, 33021-6327

  • Pfizer Investigational Site

    Jonesboro, Georgia, 30236

  • Pfizer Investigational Site

    Kansas City, Missouri, 64106

  • Pfizer Investigational Site

    Los Angeles, California, 90036

  • Pfizer Investigational Site

    Lynchburg, Virginia, 24501

  • Pfizer Investigational Site

    Metairie, Louisiana, 70006

  • Pfizer Investigational Site

    Miami, Florida, 33137

  • Pfizer Investigational Site

    Miami, Florida, 33145

  • Pfizer Investigational Site

    Miami, Florida, 33155

  • Pfizer Investigational Site

    Miami Beach, Florida, 33139

  • Pfizer Investigational Site

    New York, New York, 10011

  • Pfizer Investigational Site

    New York, New York, 10016

  • Pfizer Investigational Site

    New York, New York, 10025

  • Pfizer Investigational Site

    New York, New York, 10029

  • Pfizer Investigational Site

    Norwalk, Connecticut, 06851

  • Pfizer Investigational Site

    Oakland, California, 94609-3480

  • Pfizer Investigational Site

    Palm Springs, California, 92262

  • Pfizer Investigational Site

    Pasadena, Texas, 77505-4245

  • Pfizer Investigational Site

    Pensacola, Florida, 32504

  • Pfizer Investigational Site

    Portland, Oregon, 97210

  • Pfizer Investigational Site

    Portland, Oregon, 97227

  • Pfizer Investigational Site

    Richmond, Virginia, 23298

  • Pfizer Investigational Site

    Safety Harbor, Florida, 34695

  • Pfizer Investigational Site

    Silver Spring, Maryland, 20910

  • Pfizer Investigational Site

    Southport, Connecticut, 06490

  • Pfizer Investigational Site

    Springfield, Illinois, 62702

  • Pfizer Investigational Site

    St Louis, Missouri, 63139-2909

  • Pfizer Investigational Site

    St. Petersburg, Florida, 33713

  • Pfizer Investigational Site

    Stratford, Connecticut, 06614

  • Pfizer Investigational Site

    Tampa, Florida, 33611

  • Pfizer Investigational Site

    Tampa, Florida, 33614

  • Pfizer Investigational Site

    Tarzana, California, 91356

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74135

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20007

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20010-2976

  • Pfizer Investigational Site

    West Reading, Pennsylvania, 19611

Other trials in United States

Germany19 sites

  • Pfizer Investigational Site

    Aachen, 52062

  • Pfizer Investigational Site

    Berlin, 12157

  • Pfizer Investigational Site

    Bochum, 44791

  • Pfizer Investigational Site

    Bonn, 53105

  • Pfizer Investigational Site

    Cologne, 50924

  • Pfizer Investigational Site

    Düsseldorf, 40225

  • Pfizer Investigational Site

    Erlangen, 91054

  • Pfizer Investigational Site

    Essen, 45122

  • Pfizer Investigational Site

    Frankfurt, 60590

  • Pfizer Investigational Site

    Freiburg im Breisgau, 79098

  • Pfizer Investigational Site

    Fürth, 90762

  • Pfizer Investigational Site

    Hamburg, 20099

  • Pfizer Investigational Site

    Hamburg, 20246

  • Pfizer Investigational Site

    Hanover, 30625

  • Pfizer Investigational Site

    Mannheim, 68161

  • Pfizer Investigational Site

    München, 80336

  • Pfizer Investigational Site

    Osnabrück, 49090

  • Pfizer Investigational Site

    Stuttgart, 70197

  • Pfizer Investigational Site

    Ulm, 89081

Other trials in Germany

France15 sites

  • Pfizer Investigational Site

    Bobigny, Cedex, 93009

  • Pfizer Investigational Site

    Caen, Cedex, 14033

  • Pfizer Investigational Site

    Le Kremlin-Bicêtre, 94270

  • Pfizer Investigational Site

    Lyon, Cedex 02, 69288

  • Pfizer Investigational Site

    Marseille, Cedex 09, 13274

  • Pfizer Investigational Site

    Montpellier, 34295

  • Pfizer Investigational Site

    Nantes, 44093

  • Pfizer Investigational Site

    Nice Cedex 3, 06, 06202

  • Pfizer Investigational Site

    Orléans, Cedex 02, 45067

  • Pfizer Investigational Site

    Paris, Cedex 10, 75475

  • Pfizer Investigational Site

    Paris, Cedex 12, 75571

  • Pfizer Investigational Site

    Paris, 75015

  • Pfizer Investigational Site

    Paris, 75018

  • Pfizer Investigational Site

    Paris, 75020

  • Pfizer Investigational Site

    Toulon, Bp1412, 83056

Other trials in France

Spain13 sites

  • Pfizer Investigational Site

    Badalona, Barcelona, 08916

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08036

  • Pfizer Investigational Site

    Córdoba, Cordoba, 14004

  • Pfizer Investigational Site

    Donostia / San Sebastian, 20014

  • Pfizer Investigational Site

    Elche, Alicante, 03202

  • Pfizer Investigational Site

    Madrid, Madrid, 28006

  • Pfizer Investigational Site

    Madrid, Madrid, 28029

  • Pfizer Investigational Site

    Madrid, Madrid, 28041

  • Pfizer Investigational Site

    Madrid, Madrid, 28046

  • Pfizer Investigational Site

    Madrid, 28034

  • Pfizer Investigational Site

    Seville, Sevilla, 41013

  • Pfizer Investigational Site

    Seville, Sevilla, 41014

Other trials in Spain

Italy12 sites

  • Pfizer Investigational Site

    Antella (FI), 50011

  • Pfizer Investigational Site

    Brescia, 25123

  • Pfizer Investigational Site

    Florence, 50193

  • Pfizer Investigational Site

    Genova, 16132

  • Pfizer Investigational Site

    Milan, 20100

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Monserrato, CA, 09042

  • Pfizer Investigational Site

    Roma, 00161

  • Pfizer Investigational Site

    Roma, 00184

  • Pfizer Investigational Site

    Roma, 00185

  • Pfizer Investigational Site

    Torino, 10149

  • Pfizer Investigational Site

    Venezia, 30170

Other trials in Italy

United Kingdom12 sites

  • Pfizer Investigational Site

    Birmingham, B9 5SS

  • Pfizer Investigational Site

    Brighton, BN2 1ES

  • Pfizer Investigational Site

    Edinburgh, Loth, ED4 2XU

  • Pfizer Investigational Site

    Edinburgh, EH4 2XU

  • Pfizer Investigational Site

    Leicester, Leics, LE1 5WW

  • Pfizer Investigational Site

    London, NW3 2QG

  • Pfizer Investigational Site

    London, SE5 9RS

  • Pfizer Investigational Site

    London, SW10 9TH

  • Pfizer Investigational Site

    London, SW17 0QT

  • Pfizer Investigational Site

    London, W2 1NY

  • Pfizer Investigational Site

    Manchester, M8 5RB

  • Pfizer Investigational Site

    Newcastle Upon Tyre, NE4 6BE

Other trials in United Kingdom

Australia11 sites

  • Pfizer Investigational Site

    Burwood, New South Wales, 2134

  • Pfizer Investigational Site

    Darlinghurst, New South Wales, 2010

  • Pfizer Investigational Site

    Darlinghurst, 2010

  • Pfizer Investigational Site

    Fitzroy North, Victoria, 3068

  • Pfizer Investigational Site

    Herston, Queensland, 4029

  • Pfizer Investigational Site

    Melbourne, Victoria, 3004

  • Pfizer Investigational Site

    Miami, Queensland, 4220

  • Pfizer Investigational Site

    South Yarra, Victoria, 3141

  • Pfizer Investigational Site

    Surry Hills, New South Wales, 2010

  • Pfizer Investigational Site

    Sydney, New South Wales, 2010

  • Pfizer Investigational Site

    Wentworthville, New South Wales, 2145

Other trials in Australia

Poland7 sites

  • Pfizer Investigational Site

    Bialystok, 15-540

  • Pfizer Investigational Site

    Bydgoszcz, 85-030

  • Pfizer Investigational Site

    Chorzów, 41-500

  • Pfizer Investigational Site

    Gdansk, 80-214

  • Pfizer Investigational Site

    Krakow, 31-531

  • Pfizer Investigational Site

    Szczecin, 71-455

  • Pfizer Investigational Site

    Warsaw, 01-201

Other trials in Poland

Switzerland6 sites

  • Pfizer Investigational Site

    Basel, 4031

  • Pfizer Investigational Site

    Geneva

  • Pfizer Investigational Site

    Lausanne, 1011

  • Pfizer Investigational Site

    Lugano, 6900

  • Pfizer Investigational Site

    Sankt Gallen, 9007

  • Pfizer Investigational Site

    Zurich, 8091

Other trials in Switzerland

Belgium5 sites

  • Pfizer Investigational Site

    Brussels, 1000

  • Pfizer Investigational Site

    Brussels, 1070

  • Pfizer Investigational Site

    Brussels, 1200

  • Pfizer Investigational Site

    Ghent, 9000

  • Pfizer Investigational Site

    Liège, 4000

Other trials in Belgium

Netherlands5 sites

  • Pfizer Investigational Site

    Amsterdam, 1081 HV

  • Pfizer Investigational Site

    Amsterdam, 1105 AZ

  • Pfizer Investigational Site

    Arnhem, 6815 AD

  • Pfizer Investigational Site

    Rotterdam, 3015 GD

  • Pfizer Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Sweden3 sites

  • Pfizer Investigational Site

    Gothenburg, 41685

  • Pfizer Investigational Site

    Malmö, 214 01

  • Pfizer Investigational Site

    Venhalsan, Stockholm County, 118 83

Other trials in Sweden

Canada2 sites

  • Pfizer Investigational Site

    Montreal, Quebec, H2L 2W5

  • Pfizer Investigational Site

    Montreal, Quebec, H2L 4M1

Other trials in Canada

About this study

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

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.

Conditions
HIV Infections
Being tested
Maraviroc (UK-427,857), optimized background therapy
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maraviroc (UK-427,857)Drug

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

  • optimized background therapyDrug

    Also called Selzentry

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

  • Maraviroc (UK-427,857)Drug

    Also called Selzentry

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

  • optimized background therapyDrug

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

  • optimized background therapyDrug

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

Study groups in NCT00098722
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Maraviroc (UK-427,857); Drug: optimized background therapy
2Placebo comparatorNot described
Receives: Drug: Maraviroc (UK-427,857); Drug: optimized background therapy
3ExperimentalNot described
Receives: Drug: optimized background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline and Week 24

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

    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.

    Measured: Baseline and Week 48

Secondary outcomes (15)

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

    Measured: Week 24 and 48

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

    Measured: Week 24 and 48

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

    Measured: Week 24 and 48

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

    Measured: Week 24 and 48

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Week 24 and 48

  7. 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.

    Measured: Week 24 and 48

  8. 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.

    Measured: Week 48

  9. 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.

    Measured: Baseline to Week 24 and Week 48

  10. 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.

    Measured: Screening

  11. 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.

    Measured: Screening and time of failure through Week 24

  12. 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.

    Measured: Screening and time of failure through Week 48

  13. 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.

    Measured: Baseline and time of failure through Week 24

  14. 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.

    Measured: Baseline and time of failure through Week 48

  15. 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.

    Measured: Baseline, Week 24 and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startDec 2004
  3. Primary completionApr 2007
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
474 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098722
Sponsor's protocol ID
A4001028
Acronym
MOTIVATE 2
Status last verified
Apr 2012
First submitted
7 Dec 2004
Last updated
16 May 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34343443

  • 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.

    PubMed 24419064

  • 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.

    PubMed 20703158

  • 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.

    PubMed 18832245

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Maraviroc (UK-427,857) and optimized background therapy in people with HIV Infections, run by ViiV Healthcare at 172 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Germany, France, Spain, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098722, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.

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