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 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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00098722

Acronym

MOTIVATE 2

Enrollment

474

Registered

2004-12-08

Start date

2004-12-31

Completion date

2011-04-30

Last updated

2012-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

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.

Interventions

DRUGMaraviroc (UK-427,857)

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

DRUGoptimized background therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24 and 48	—
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	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	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	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	Week 48	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	Baseline to Week 24 and Week 48	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.
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24 and 48	—
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Screening and time of 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	Screening and time of 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	Baseline and time of 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	Baseline and time of 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	Baseline, Week 24 and Week 48	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.
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	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.
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	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	Week 24 and 48	—

Countries

Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Maraviroc QD Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.	182
Maraviroc BID Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).	191
Placebo Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).	91
Total	464

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Double Blind Phase	Adverse Event	7	7	3	0	0	0	0
Double Blind Phase	Death	2	5	0	0	0	0	0
Double Blind Phase	Lack of Efficacy	21	23	15	0	0	0	0
Double Blind Phase	Ongoing at cut-off date	128	137	57	0	0	0	0
Double Blind Phase	Other	7	8	7	0	0	0	0
Double Blind Phase	Participant defaulted	16	11	9	0	0	0	0
Double Blind Phase	Pregnancy	1	0	0	0	0	0	0
Double Blind Phase	Randomized, not treated	4	3	3	0	0	0	0
Observation Phase	Death	0	0	0	0	0	5	3
Observation Phase	Lack of Efficacy	0	0	0	0	0	2	0
Observation Phase	Other	0	0	0	0	0	21	10
Observation Phase	Participant defaulted	0	0	0	0	0	17	4
Open Label Phase	Adverse Event	0	0	0	5	0	0	0
Open Label Phase	Death	0	0	0	2	0	0	0
Open Label Phase	Lack of Efficacy	0	0	0	8	0	0	0
Open Label Phase	Ongoing at cut-off date	0	0	0	220	50	0	0
Open Label Phase	Other	0	0	0	18	0	0	0
Open Label Phase	Participant defaulted	0	0	0	18	0	0	0
Open Label Phase	Pregnancy	0	0	0	1	0	0	0

Baseline characteristics

Characteristic	Total	Maraviroc QD	Maraviroc BID	Placebo
Age, Customized 18 to 24 years	2 participants	1 participants	1 participants	0 participants
Age, Customized 25 to 34 years	23 participants	8 participants	9 participants	6 participants
Age, Customized 35 to 44 years	196 participants	85 participants	71 participants	40 participants
Age, Customized 45 to 54 years	165 participants	63 participants	70 participants	32 participants
Age, Customized 55 to 64 years	67 participants	19 participants	37 participants	11 participants
Age, Customized Greater than or equal to 65 years	10 participants	5 participants	3 participants	2 participants
Age, Customized Less than 18 years	1 participants	1 participants	0 participants	0 participants
Sex: Female, Male Female	62 Participants	29 Participants	21 Participants	12 Participants
Sex: Female, Male Male	402 Participants	153 Participants	170 Participants	79 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	138 / 182	147 / 191	64 / 91	15 / 272	0 / 50	0 / 205	0 / 65
serious Total, serious adverse events	40 / 182	46 / 191	16 / 91	28 / 272	0 / 50	0 / 205	0 / 65

Outcome results

Primary

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.

Time frame: Baseline and Week 24

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-1.950 log10 copies/mL	Standard Error 0.1054
Maraviroc BID	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-1.971 log10 copies/mL	Standard Error 0.1026
Placebo	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-0.929 log10 copies/mL	Standard Error 0.1473

Comparison: The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.97.5% CI: [-1.426, -0.616]

Comparison: The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.97.5% CI: [-1.444, -0.64]

Primary

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

Time frame: Baseline and Week 48

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-1.718 log10 copies/mL	Standard Error 0.1086
Maraviroc BID	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-1.865 log10 copies/mL	Standard Error 0.1057
Placebo	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-0.757 log10 copies/mL	Standard Error 0.1518

Primary

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.

Time frame: Baseline

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

Arm	Measure	Value (MEAN)	Dispersion
Maraviroc QD	Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline	4.873 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.6641
Maraviroc BID	Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline	4.840 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.6205
Placebo	Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline	4.886 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.6957

Secondary

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.

Time frame: Week 24 and 48

Population: FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 24	111.72 cells/μL	Standard Error 7.821
Maraviroc QD	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	121.49 cells/μL	Standard Error 8.651
Maraviroc BID	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 24	101.89 cells/μL	Standard Error 7.684
Maraviroc BID	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	127.80 cells/μL	Standard Error 8.499
Placebo	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 24	63.78 cells/μL	Standard Error 10.929
Placebo	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	69.34 cells/μL	Standard Error 12.088

Comparison: Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.95% CI: [21.64, 74.25]

Comparison: Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.95% CI: [23.06, 81.25]

Secondary

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 frame: Week 24 and 48

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 24	340.74 cells/μL	Standard Error 41.601
Maraviroc QD	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	241.43 cells/μL	Standard Error 33.789
Maraviroc BID	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 24	255.40 cells/μL	Standard Error 40.873
Maraviroc BID	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	244.75 cells/μL	Standard Error 33.198
Placebo	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 24	122.18 cells/μL	Standard Error 58.15
Placebo	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	104.51 cells/μL	Standard Error 47.231

Secondary

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.

Time frame: Baseline, Week 24 and Week 48

Population: FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 0 (n= 22, 29, 16)	-1.721 log10copies/mL	Standard Deviation 1.0477
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 1 (n= 54, 48, 23)	-1.822 log10copies/mL	Standard Deviation 1.0244
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 2 (n= 37, 39, 21)	-2.145 log10copies/mL	Standard Deviation 1.4052
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS >=3 (n= 64, 68, 29)	-2.655 log10copies/mL	Standard Deviation 1.1364
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS= Missing (n= 3, 1, 2)	-2.642 log10copies/mL	Standard Deviation 0.9282
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 0 (n= 22, 29, 16)	-1.745 log10copies/mL	Standard Deviation 1.2354
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 1 (n= 54, 48, 23)	-1.678 log10copies/mL	Standard Deviation 1.2115
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 2 (n= 38, 39, 21)	-2.207 log10copies/mL	Standard Deviation 1.3866
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS >=3 (n= 63, 68, 29)	-2.448 log10copies/mL	Standard Deviation 1.2477
Maraviroc QD	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS= Missing (n= 3, 1, 2)	-2.795 log10copies/mL	Standard Deviation 0.5079
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS >=3 (n= 63, 68, 29)	-2.426 log10copies/mL	Standard Deviation 1.2977
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 0 (n= 22, 29, 16)	-1.231 log10copies/mL	Standard Deviation 1.2924
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 0 (n= 22, 29, 16)	-1.290 log10copies/mL	Standard Deviation 1.2978
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS= Missing (n= 3, 1, 2)	-0.544 log10copies/mL	—
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 1 (n= 54, 48, 23)	-2.051 log10copies/mL	Standard Deviation 1.186
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS= Missing (n= 3, 1, 2)	-0.833 log10copies/mL	—
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 2 (n= 38, 39, 21)	-2.565 log10copies/mL	Standard Deviation 0.8734
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 2 (n= 37, 39, 21)	-2.515 log10copies/mL	Standard Deviation 0.8209
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 1 (n= 54, 48, 23)	-1.899 log10copies/mL	Standard Deviation 1.1966
Maraviroc BID	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS >=3 (n= 64, 68, 29)	-2.530 log10copies/mL	Standard Deviation 1.2694
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 2 (n= 38, 39, 21)	-0.591 log10copies/mL	Standard Deviation 0.9309
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS >=3 (n= 64, 68, 29)	-2.109 log10copies/mL	Standard Deviation 1.3495
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS= Missing (n= 3, 1, 2)	-1.169 log10copies/mL	Standard Deviation 2.135
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 0 (n= 22, 29, 16)	-0.249 log10copies/mL	Standard Deviation 0.8727
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS >=3 (n= 63, 68, 29)	-1.942 log10copies/mL	Standard Deviation 1.4167
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS 1 (n= 54, 48, 23)	-0.594 log10copies/mL	Standard Deviation 0.9454
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 0 (n= 22, 29, 16)	-0.264 log10copies/mL	Standard Deviation 0.8979
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 48; Screening OSS= Missing (n= 3, 1, 2)	-1.105 log10copies/mL	Standard Deviation 2.0447
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 1 (n= 54, 48, 23)	-0.651 log10copies/mL	Standard Deviation 0.9756
Placebo	Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening	Week 24; Screening OSS 2 (n= 37, 39, 21)	-0.611 log10copies/mL	Standard Deviation 0.9732

Secondary

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.

Time frame: Baseline

Arm	Measure	Group	Value (MEAN)	Dispersion
Maraviroc QD	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD4	206.0 cells per microliter (cells/μL)	Standard Deviation 171.99
Maraviroc QD	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	994.6 cells per microliter (cells/μL)	Standard Deviation 658.03
Maraviroc BID	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD4	204.9 cells per microliter (cells/μL)	Standard Deviation 149.21
Maraviroc BID	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	996.9 cells per microliter (cells/μL)	Standard Deviation 576.97
Placebo	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD4	198.5 cells per microliter (cells/μL)	Standard Deviation 140.39
Placebo	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	952.3 cells per microliter (cells/μL)	Standard Deviation 598.19

Secondary

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.

Time frame: Baseline and time of failure through Week 24

Population: FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: R5	8 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: X4	2 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: DM	5 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: NR/NP	6 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: R5	1 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: X4	0 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: DM	3 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: NR/NP	0 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: DM	6 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: DM	7 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: NR/NP	5 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: R5	0 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: X4	2 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: R5	7 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: X4	2 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: NR/NP	1 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: DM	3 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: X4	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: R5	36 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: R5; Treatment failure: NR/NP	2 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: DM	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: X4	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: R5	2 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24	Baseline: DM; Treatment failure: NR/NP	0 participants

Secondary

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.

Time frame: Baseline and time of failure through Week 48

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: R5	17 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: X4	2 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: DM	8 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: NR/NP	6 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: R5	1 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: X4	0 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: DM	3 participants
Maraviroc QD	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: NR/NP	0 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: DM	10 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: DM	7 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: NR/NP	6 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: R5	0 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: X4	2 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: R5	9 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: X4	2 participants
Maraviroc BID	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: NR/NP	1 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: DM	3 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: X4	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: R5	40 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: R5; Treatment failure: NR/NP	2 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: DM	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: X4	0 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: R5	3 participants
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM; Treatment failure: NR/NP	0 participants

Secondary

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.

Time frame: Screening and time of failure through Week 24

Population: FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 0 (n= 22, 25, 40)	13 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -3 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -2 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -1 (n= 22, 25, 40)	9 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by less than -3 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 1 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 2 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 3 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by greater than 3 (n= 22, 25, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by less than -3 (n= 22, 24, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -3 (n= 22, 24, 40)	1 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -2 (n= 22, 24, 40)	2 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -1 (n= 22, 24, 40)	8 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 0 (n= 22, 24, 40)	10 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 1 (n= 22, 24, 40)	1 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 2 (n= 22, 24, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 3 (n= 22, 24, 40)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by greater than 3 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by greater than 3 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by less than -3 (n= 22, 25, 40)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by less than -3 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -1 (n= 22, 24, 40)	8 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -3 (n= 22, 25, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 1 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 2 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -2 (n= 22, 25, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -3 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 3 (n= 22, 24, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -1 (n= 22, 25, 40)	6 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by greater than 3 (n= 22, 25, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 0 (n= 22, 24, 40)	13 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 0 (n= 22, 25, 40)	15 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 3 (n= 22, 25, 40)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -2 (n= 22, 24, 40)	3 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 1 (n= 22, 25, 40)	3 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 2 (n= 22, 25, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 1 (n= 22, 25, 40)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 2 (n= 22, 25, 40)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 3 (n= 22, 25, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 1 (n= 22, 24, 40)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by greater than 3 (n= 22, 25, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by greater than 3 (n= 22, 24, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by less than -3 (n= 22, 24, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -3 (n= 22, 24, 40)	2 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 2 (n= 22, 24, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -2 (n= 22, 24, 40)	3 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by less than -3 (n= 22, 25, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -3 (n= 22, 25, 40)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by -1 (n= 22, 24, 40)	16 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -2 (n= 22, 25, 40)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by -1 (n= 22, 25, 40)	15 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in GSS by 0 (n= 22, 25, 40)	22 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 0 (n= 22, 24, 40)	18 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24	Change in PSS by 3 (n= 22, 24, 40)	0 participants

Secondary

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.

Time frame: Screening and time of failure through Week 48

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 2 (n= 35, 32, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 2 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 1 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -2 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 3 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 3 (n= 35, 32, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 0 (n= 35, 33, 46)	23 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by greater than 3 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 1 (n= 35, 32, 46)	2 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by less than -3 (n= 35, 33, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by less than -3 (n= 35, 32, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by greater than 3 (n= 35, 32, 46)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -1 (n= 35, 33, 46)	12 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -3 (n= 35, 32, 46)	1 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 0 (n= 35, 32, 46)	16 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -1 (n= 35, 32, 46)	13 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -2 (n= 35, 32, 46)	3 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -3 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -2 (n= 35, 32, 46)	3 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -1 (n= 35, 32, 46)	9 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 0 (n= 35, 32, 46)	19 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 0 (n= 35, 33, 46)	22 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 1 (n= 35, 32, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -3 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 3 (n= 35, 32, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 1 (n= 35, 33, 46)	4 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by greater than 3 (n= 35, 32, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 2 (n= 35, 32, 46)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by less than -3 (n= 35, 33, 46)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 2 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 3 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -2 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by greater than 3 (n= 35, 33, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by less than -3 (n= 35, 32, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -3 (n= 35, 32, 46)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -1 (n= 35, 33, 46)	6 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by greater than 3 (n= 35, 32, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by less than -3 (n= 35, 33, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -3 (n= 35, 33, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -2 (n= 35, 33, 46)	2 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by -1 (n= 35, 33, 46)	17 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 0 (n= 35, 33, 46)	24 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 1 (n= 35, 33, 46)	2 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 2 (n= 35, 33, 46)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by 3 (n= 35, 33, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in GSS by greater than 3 (n= 35, 33, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by less than -3 (n= 35, 32, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -3 (n= 35, 32, 46)	3 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -2 (n= 35, 32, 46)	4 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by -1 (n= 35, 32, 46)	18 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 0 (n= 35, 32, 46)	19 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 1 (n= 35, 32, 46)	2 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 2 (n= 35, 32, 46)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48	Change in PSS by 3 (n= 35, 32, 46)	0 participants

Secondary

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.

Time frame: Screening

Population: FAS included all the randomized participants who had taken at least one dose of the study medication.

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	39 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	64 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	25 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	52 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	2 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	20 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	46 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	42 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	71 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	3 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	84 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	43 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	26 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	1 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	58 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	1 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	38 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	32 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	42 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	57 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	23 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	25 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	2 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	12 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	34 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	20 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	20 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	2 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	24 participants
Placebo	Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	20 participants

Secondary

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

Time frame: Week 24 and 48

Population: FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels.

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24	55.49 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	52.75 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24	61.26 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	54.97 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24	23.08 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	23.08 percentage of participants

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.p-value: <0.000195% CI: [2.56, 8.23]Regression, Logistic

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [3.35, 10.78]Regression, Logistic

Comparison: Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [2.25, 7.2]Regression, Logistic

Secondary

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

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 24	69.78 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 48	60.99 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 24	72.25 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 48	65.97 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 24	37.36 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline	Week 48	31.87 percentage of participants

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [2.72, 8.1]Regression, Logistic

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [2.91, 8.62]Regression, Logistic

Secondary

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

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 24	66.48 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 48	58.79 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 24	69.63 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 48	63.35 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 24	30.77 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline	Week 48	27.47 percentage of participants

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [2.64, 7.92]Regression, Logistic

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [3.13, 9.39]Regression, Logistic

Secondary

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

Time frame: Week 24 and 48

Arm	Measure	Group	Value (NUMBER)
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24	45.60 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	45.05 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24	40.84 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	44.50 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24	20.88 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	17.58 percentage of participants

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.p-value: <0.000195% CI: [1.95, 6.48]Regression, Logistic

Comparison: Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.p-value: 0.000595% CI: [1.59, 5.23]Regression, Logistic

Secondary

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.

Time frame: Baseline to Week 24 and Week 48

Population: FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 24	-1.748 log10 copies/mL	Standard Error 0.0897
Maraviroc QD	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-1.603 log10 copies/mL	Standard Error 0.0994
Maraviroc BID	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 24	-1.755 log10 copies/mL	Standard Error 0.0873
Maraviroc BID	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-1.781 log10 copies/mL	Standard Error 0.0968
Placebo	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 24	-0.872 log10 copies/mL	Standard Error 0.1254
Placebo	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-0.748 log10 copies/mL	Standard Error 0.139

Comparison: Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.95% CI: [-1.177, -0.575]

Comparison: Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.95% CI: [-1.189, -0.521]

Secondary

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 frame: Week 48

Population: FAS included all the randomized participants who had taken at least one dose of the study medication.

Arm	Measure	Value (MEDIAN)
Maraviroc QD	Time to Virological Failure	345.00 days
Maraviroc BID	Time to Virological Failure	361.00 days
Placebo	Time to Virological Failure	0.00 days

Comparison: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.p-value: <0.000195% CI: [0.29, 0.56]Log Rank

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

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

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

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

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

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

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

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

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

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

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

Time to Virological Failure