HIV InfectionsPhase 2/3MOTIVATE 1NCT00098306

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 22 sites in 2 countries.

Completed

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

Official record

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Trial summary

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: 601 participants
Where: 22 sitesin 2 countries
Study dates: Nov 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 years 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 judgement, to prevent adherence to study medication and/or follow up
Lactating women, or planned pregnancy during the trial period

Show all 17Show fewer

Significant renal insufficiency
Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic 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
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

22 sites in 2 countries.

Country

City, postcode or hospital

22 sites in 2 countries

United States20 sites

Pfizer Investigational Site
Annandale, Virginia, 22003
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Auroa, Colorado, 80045
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0405
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New York, New York, 10003
Pfizer Investigational Site
Portland, Oregon, 97219
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94118
Pfizer Investigational Site
San Francisco, California, 94121
Pfizer Investigational Site
Santa Fe, New Mexico, 87505
Pfizer Investigational Site
Tampa, Florida, 33602
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Vero Beach, Florida, 32960
Pfizer Investigational Site
Washington D.C., District of Columbia, 20036

Other trials in United States

Canada2 sites

Pfizer Investigational Site
Montreal, Quebec, H2L 4P9
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 1Y6

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 are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada 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, Placebo
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
Also called Selzentry
Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
Optimized Background TherapyDrug
Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy
Optimized Background TherapyDrug
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.
PlaceboDrug
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.
Optimized Background TherapyDrug
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.

Study groups in NCT00098306
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Maraviroc (UK-427,857); Drug: Optimized Background Therapy
2	Experimental	Not described Receives: Drug: Optimized Background Therapy; Drug: Placebo
3	Experimental	Not described Receives: Drug: Optimized Background Therapy

What is being measured

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

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
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
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)

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Measured: Week 24 and 48
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
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
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Measured: Week 24 and 48
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
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 the average of pre-dose measurements collected at screening and immediately pre-dose.
Measured: Baseline, Week 24 and 48
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 the average of pre-dose measurements collected at screening and immediately pre-dose.
Measured: Baseline, Week 24 and 48
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
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
Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), 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
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 assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and 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
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48
Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and 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
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
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 treatment failure analyzed through week 48 visit. Treatment failure defined as 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
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.

Nov 2004Apr 2011

First posted7 Dec 2004 (estimated)
Study startNov 2004
Primary completionApr 2007
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 601 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00098306
Sponsor's protocol ID: A4001027
Acronym: MOTIVATE 1
Status last verified: Apr 2012
First submitted: 6 Dec 2004
Last updated: 27 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
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.
PubMed 18832244

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00098306
Acronym / sponsor ID: MOTIVATE 1 / A4001027
Conditions: HIV Infections
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 601 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Nov 2004
Primary completion: Apr 2007 (actual)
Study completion: Apr 2011 (actual)
First posted: 7 Dec 2004 (estimated)
Results: Posted 27 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: Maraviroc (UK-427,857), Drug: Optimized Background Therapy
2	Experimental	Drug: Optimized Background Therapy, Drug: Placebo
3	Experimental	Drug: Optimized Background Therapy

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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 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

Key exclusion criteria (17 listed)

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 judgement, to prevent adherence to study medication and/or follow up

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Maraviroc (UK-427,857)Also: SelzentryMaraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy	Drug	1
Optimized Background TherapyMaraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy	Drug	1
Optimized Background TherapyPatients 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.	Drug	2
PlaceboPatients 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.	Drug	2
Optimized Background TherapyPatients 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.	Drug	3

Primary outcome

Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline
Time frame: 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
Time frame: Baseline and 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
Time frame: Baseline and 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.

15 secondary outcomes

Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Time frame: Week 24 and 48
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
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
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Time frame: Week 24 and 48
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline
Time frame: Baseline
Change From Baseline in CD4 Cell Count at Week 24 and 48
Time frame: Baseline, Week 24 and 48
Change From Baseline in CD8 Cell Count at Week 24 and 48
Time frame: Baseline, Week 24 and 48
Time to Virological Failure
Time frame: Week 48
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels
Time frame: Baseline to Week 24 and Week 48
Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening
Time frame: Screening
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24
Time frame: Screening and time of failure through week 24
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48
Time frame: Screening and time of failure through week 48
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24
Time frame: Baseline and time of failure through week 24
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48
Time frame: Baseline and time of failure through week 48
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening
Time frame: Baseline, Week 24 and Week 48

Results and safety

Results posted to the registry on 27 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maraviroc QD, Double Blind	241	0
Maraviroc BID, Double Blind	240	0
Placebo, Double Blind	120	0
Maraviroc BID, Open Label	0	0
In Study-off Drug (ISOD), Open Label	0	0
Maraviroc BID, Observation Phase	0	0
In Study-off Drug (ISOD), Observation Phase	0	0

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

Time frame: Baseline. Mean (Standard Deviation). Unit: log10 copies/milliliter(log10 copies/mL)

Measure	Maraviroc QD n = 232	Maraviroc BID n = 235	Placebo n = 118
Value	4.854 (0.641)	4.861 (0.614)	4.840 (0.556)

Population analysed: Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.

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

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: log10 copies/mL

Measure	Maraviroc QD n = 232	Maraviroc BID n = 235	Placebo n = 118
Value	-1.818 (0.0920)	-1.952 (0.0913)	-1.030 (0.1287)

Maraviroc QD vs Placebo: LS mean difference: -0.788 (97.5% CI -1.141 to -0.435)
Maraviroc BID vs Placebo: LS mean difference: -0.922 (97.5% CI -1.275 to -0.570)

Population analysed: FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.

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

Time frame: Baseline and Week 48. Least squares mean (Standard Error). Unit: log10 copies/mL

Measure	Maraviroc QD n = 232	Maraviroc BID n = 235	Placebo n = 118
Value	-1.656 (0.0949)	-1.824 (0.0942)	-0.803 (0.1329)

Maraviroc QD vs Placebo: LS mean difference: -0.853 (97.5% CI -1.217 to -0.489)
Maraviroc BID vs Placebo: LS mean difference: -1.021 (97.5% CI -1.385 to -0.658)

Population analysed: FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc QD, Double Blind	42 of 232 (18.1%)	170 of 232 (73.3%)	Not reported
Maraviroc BID, Double Blind	53 of 235 (22.6%)	192 of 235 (81.7%)	Not reported
Placebo, Double Blind	20 of 118 (16.9%)	89 of 118 (75.4%)	Not reported
Maraviroc BID, Open Label	33 of 327 (10.1%)	19 of 327 (5.8%)	Not reported
In Study-off Drug (ISOD), Open Label	0 of 62 (0%)	0 of 62 (0%)	Not reported
Maraviroc BID, Observation Phase	0 of 250 (0%)	0 of 250 (0%)	Not reported
In Study-off Drug (ISOD), Observation Phase	0 of 81 (0%)	0 of 81 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34343443Lewis 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.
Derived from this study: PubMed 24419064Gulick 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.
Derived from this study: PubMed 20703158Hardy 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.
Derived from this study: PubMed 18832245Fatkenheuer 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.
Derived from this study: PubMed 18832244Gulick 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

22 sites in 2 countries: see every site and its status.

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 22 sites in 2 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 17 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 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Canada. 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. 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 27 Apr 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 NCT00098306, 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 27 Apr 2012.