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

NCT00098306

Acronym

MOTIVATE 1

Enrollment

601

Registered

2004-12-07

Start date

2004-11-30

Completion date

2011-04-30

Last updated

2012-04-27

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 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.

Interventions

DRUGMaraviroc (UK-427,857)

Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy

DRUGOptimized Background Therapy

Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy

DRUGPlacebo

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.

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 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

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 judgement, to prevent adherence to study medication and/or follow up * Lactating women, or planned pregnancy during the trial period * 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

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	Baseline, 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.
Change From Baseline in CD8 Cell Count at Week 24 and 48	Baseline, 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.
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 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.
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Screening and time of failure through 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.
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 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.
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 Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	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.
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

Canada, 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.	232
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).	235
Placebo Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).	118
Total	585

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Double Blind	Adverse Event	11	10	6	0	0	0	0
Double Blind	Death	1	4	1	0	0	0	0
Double Blind	Lack of Efficacy	43	34	17	0	0	0	0
Double Blind	Ongoing at cut-off date	151	166	72	0	0	0	0
Double Blind	Participant defaulted	19	18	11	0	0	0	0
Double Blind	Randomized, not treated	9	5	2	0	0	0	0
Double Blind	Un-specified	7	3	11	0	0	0	0
Observational Phase	Death	0	0	0	0	0	5	4
Observational Phase	Participant defaulted	0	0	0	0	0	34	18
Observational Phase	Un-specified	0	0	0	0	0	7	4
Open Label	Adverse Event	0	0	0	2	0	0	0
Open Label	Death	0	0	0	4	0	0	0
Open Label	Lack of Efficacy	0	0	0	13	0	0	0
Open Label	Ongoing at cut-off date	0	0	0	269	62	0	0
Open Label	Participant defaulted	0	0	0	24	0	0	0
Open Label	Un-specified	0	0	0	15	0	0	0

Baseline characteristics

Characteristic	Total	Maraviroc QD	Maraviroc BID	Placebo
Age, Customized 18 to 24 years	1 participants	1 participants	0 participants	0 participants
Age, Customized 25 to 34 years	22 participants	10 participants	7 participants	5 participants
Age, Customized 35 to 44 years	253 participants	97 participants	108 participants	48 participants
Age, Customized 45 to 54 years	228 participants	93 participants	90 participants	45 participants
Age, Customized 55 to 64 years	73 participants	26 participants	28 participants	19 participants
Age, Customized Greater than or equal to 65 years	8 participants	5 participants	2 participants	1 participants
Age, Customized Less than 18 years	0 participants	0 participants	0 participants	0 participants
Sex: Female, Male Female	57 Participants	22 Participants	23 Participants	12 Participants
Sex: Female, Male Male	528 Participants	210 Participants	212 Participants	106 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	170 / 232	192 / 235	89 / 118	19 / 327	0 / 62	0 / 250	0 / 81
serious Total, serious adverse events	42 / 232	53 / 235	20 / 118	33 / 327	0 / 62	0 / 250	0 / 81

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 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.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-1.818 log10 copies/mL	Standard Error 0.092
Maraviroc BID	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-1.952 log10 copies/mL	Standard Error 0.0913
Placebo	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24	-1.030 log10 copies/mL	Standard Error 0.1287

Comparison: The difference between the treatment least square means (LS means) adjusted for the 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: [-1.141, -0.435]

Comparison: The difference between the treatment LS means adjusted for the 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: [-1.275, -0.57]

Primary

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

Time frame: Baseline and Week 48

Population: 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.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Maraviroc QD	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-1.656 log10 copies/mL	Standard Error 0.0949
Maraviroc BID	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-1.824 log10 copies/mL	Standard Error 0.0942
Placebo	Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48	-0.803 log10 copies/mL	Standard Error 0.1329

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	4.854 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.641
Maraviroc BID	Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline	4.861 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.614
Placebo	Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline	4.840 log10 copies/milliliter(log10 copies/mL)	Standard Deviation 0.556

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 the average of pre-dose measurements collected at screening and immediately pre-dose.

Time frame: Baseline, 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	106.63 cells/µL	Standard Error 7.255
Maraviroc QD	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	112.53 cells/µL	Standard Error 7.39
Maraviroc BID	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 24	111.08 cells/µL	Standard Error 7.148
Maraviroc BID	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	122.44 cells/µL	Standard Error 7.284
Placebo	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 24	52.14 cells/µL	Standard Error 10.14
Placebo	Change From Baseline in CD4 Cell Count at Week 24 and 48	Week 48	53.97 cells/µL	Standard Error 10.341

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: [30.07, 78.92]

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: [33.66, 83.46]

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 the average of pre-dose measurements collected at screening and immediately pre-dose.

Time frame: Baseline, 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	283.48 cells/µL	Standard Error 30.206
Maraviroc QD	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	198.00 cells/µL	Standard Error 28.962
Maraviroc BID	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 24	302.33 cells/µL	Standard Error 29.745
Maraviroc BID	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	220.40 cells/µL	Standard Error 28.532
Placebo	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 24	-0.74 cells/µL	Standard Error 42.198
Placebo	Change From Baseline in CD8 Cell Count at Week 24 and 48	Week 48	-15.34 cells/µL	Standard Error 40.503

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 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= 29, 27, 19)	-0.945 log10copies/mL	Standard Deviation 0.905
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= 76, 86, 21)	-1.911 log10copies/mL	Standard Deviation 1.229
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= 51, 65, 38)	-2.093 log10copies/mL	Standard Deviation 1.3402
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= 68, 53, 35)	-2.536 log10copies/mL	Standard Deviation 1.1599
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= 4, 3, 3)	-2.070 log10copies/mL	Standard Deviation 1.3832
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= 29, 27, 19)	-0.876 log10copies/mL	Standard Deviation 0.8448
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= 77, 86, 20)	-1.843 log10copies/mL	Standard Deviation 1.2452
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= 51, 64, 38)	-2.146 log10copies/mL	Standard Deviation 1.4208
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= 67, 54, 36)	-2.427 log10copies/mL	Standard Deviation 1.3136
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= 4, 3, 3)	-2.106 log10copies/mL	Standard Deviation 1.4461
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= 67, 54, 36)	-2.634 log10copies/mL	Standard Deviation 1.1628
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= 29, 27, 19)	-1.524 log10copies/mL	Standard Deviation 1.331
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= 29, 27, 19)	-1.419 log10copies/mL	Standard Deviation 1.3042
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= 4, 3, 3)	-3.075 log10copies/mL	Standard Deviation 0.5705
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= 76, 86, 21)	-1.895 log10copies/mL	Standard Deviation 1.395
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= 4, 3, 3)	-2.698 log10copies/mL	Standard Deviation 1.2056
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= 51, 64, 38)	-2.182 log10copies/mL	Standard Deviation 1.1096
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= 51, 65, 38)	-2.220 log10copies/mL	Standard Deviation 1.09
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= 77, 86, 20)	-1.868 log10copies/mL	Standard Deviation 1.4078
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= 68, 53, 35)	-2.672 log10copies/mL	Standard Deviation 1.1836
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= 51, 64, 38)	-1.147 log10copies/mL	Standard Deviation 0.9681
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= 68, 53, 35)	-2.471 log10copies/mL	Standard Deviation 0.92
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= 4, 3, 3)	-0.530 log10copies/mL	Standard Deviation 0.1726
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= 29, 27, 19)	-0.088 log10copies/mL	Standard Deviation 0.4541
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= 67, 54, 36)	-2.205 log10copies/mL	Standard Deviation 1.087
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= 77, 86, 20)	-0.262 log10copies/mL	Standard Deviation 0.7048
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= 29, 27, 19)	-0.083 log10copies/mL	Standard Deviation 0.472
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= 4, 3, 3)	-0.370 log10copies/mL	Standard Deviation 0.1471
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= 76, 86, 21)	-0.350 log10copies/mL	Standard Deviation 0.784
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= 51, 65, 38)	-1.251 log10copies/mL	Standard Deviation 1.08

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	187.5 cells per microliter (cells/µL)	Standard Deviation 149.88
Maraviroc QD	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	941.1 cells per microliter (cells/µL)	Standard Deviation 556.53
Maraviroc BID	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD4	176.5 cells per microliter (cells/µL)	Standard Deviation 143.93
Maraviroc BID	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	880.1 cells per microliter (cells/µL)	Standard Deviation 547.19
Placebo	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD4	178.5 cells per microliter (cells/µL)	Standard Deviation 127.09
Placebo	Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline	CD8	880.4 cells per microliter (cells/µL)	Standard Deviation 489.28

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	10 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	6 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	18 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	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: R5	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: X4	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: 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	1 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	19 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	4 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	3 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	4 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	10 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	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: 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	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: 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	44 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	3 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	1 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	1 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	1 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 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.

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: DM, 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: DM, Treatment failure: DM	4 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	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: R5	16 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	6 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	19 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	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: 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: NR/NP	1 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	3 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	15 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	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: DM	22 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	4 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	5 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
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
Placebo	Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48	Baseline: DM, Treatment failure: DM	1 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	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: R5	49 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	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: 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: DM, Treatment failure: R5	2 participants

Secondary

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.

Time frame: Screening and time of failure through week 48

Population: FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to 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 at Week 48	Change in GSS by 0 (n= 44 ,52, 55)	26 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -3 (n= 44 ,52, 55)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -2 (n= 44 ,52, 55)	5 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -1 (n= 44 ,52, 55)	12 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by less than -3 (n= 44 ,52, 55)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 1 (n= 44 ,52, 55)	1 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 2 (n= 44 ,52, 55)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 3 (n= 44 ,52, 55)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by greater than 3 (n= 44 ,52, 55)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by less than -3 (n= 44 , 52, 53)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -3 (n= 44 , 52, 53)	4 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -2 (n= 44 , 52, 53)	6 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -1 (n= 44 , 52, 53)	13 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 0 (n= 44 , 52, 53)	17 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 1 (n= 44 , 52, 53)	3 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 2 (n= 44 , 52, 53)	0 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 3 (n= 44 , 52, 53)	1 participants
Maraviroc QD	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by greater than 3 (n= 44 , 52, 53)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by greater than 3 (n= 44 , 52, 53)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by less than -3 (n= 44 ,52, 55)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by less than -3 (n= 44 , 52, 53)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -1 (n= 44 , 52, 53)	21 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -3 (n= 44 ,52, 55)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 1 (n= 44 , 52, 53)	3 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 2 (n= 44 , 52, 53)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -2 (n= 44 ,52, 55)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -3 (n= 44 , 52, 53)	1 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 3 (n= 44 , 52, 53)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -1 (n= 44 ,52, 55)	17 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by greater than 3 (n= 44 ,52, 55)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 0 (n= 44 , 52, 53)	23 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 0 (n= 44 ,52, 55)	31 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 3 (n= 44 ,52, 55)	0 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -2 (n= 44 , 52, 53)	3 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 1 (n= 44 ,52, 55)	2 participants
Maraviroc BID	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 2 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 1 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 2 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 3 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 1 (n= 44 , 52, 53)	4 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by greater than 3 (n= 44 ,52, 55)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by greater than 3 (n= 44 , 52, 53)	0 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by less than -3 (n= 44 , 52, 53)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -3 (n= 44 , 52, 53)	3 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 2 (n= 44 , 52, 53)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -2 (n= 44 , 52, 53)	6 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by less than -3 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -3 (n= 44 ,52, 55)	1 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by -1 (n= 44 , 52, 53)	12 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -2 (n= 44 ,52, 55)	2 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by -1 (n= 44 ,52, 55)	15 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in GSS by 0 (n= 44 ,52, 55)	33 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 0 (n= 44 , 52, 53)	26 participants
Placebo	Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48	Change in PSS by 3 (n= 44 , 52, 53)	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 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.

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= 35 ,40, 47)	23 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= 35 ,40, 47)	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= 35 ,40, 47)	3 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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 45)	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= 35 ,40, 45)	4 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= 35 ,40, 45)	4 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= 35 ,40, 45)	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 0 (n= 35 ,40, 45)	15 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= 35 ,40, 45)	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 2 (n= 35 ,40, 45)	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= 35 ,40, 45)	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= 35 ,40, 45)	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 less than -3 (n= 35 ,40, 45)	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= 35 ,40, 47)	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= 35 ,40, 45)	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 PSS by greater than 3 (n= 35 ,40, 45)	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 -3 (n= 35 ,40, 47)	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= 35 ,40, 45)	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= 35 ,40, 45)	18 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= 35 ,40, 47)	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= 35 ,40, 45)	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 GSS by greater than 3 (n= 35 ,40, 47)	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= 35 ,40, 47)	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 3 (n= 35 ,40, 47)	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= 35 ,40, 45)	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 0 (n= 35 ,40, 47)	26 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= 35 ,40, 45)	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 0 (n= 35 ,40, 45)	17 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= 35 ,40, 47)	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 GSS by 2 (n= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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= 35 ,40, 47)	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 PSS by 1 (n= 35 ,40, 45)	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 GSS by greater than 3 (n= 35 ,40, 47)	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= 35 ,40, 45)	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= 35 ,40, 45)	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 PSS by -3 (n= 35 ,40, 45)	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 PSS by 2 (n= 35 ,40, 45)	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 0 (n= 35 ,40, 45)	25 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= 35 ,40, 45)	4 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= 35 ,40, 47)	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= 35 ,40, 47)	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 -2 (n= 35 ,40, 47)	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 PSS by -1 (n= 35 ,40, 45)	12 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= 35 ,40, 47)	11 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= 35 ,40, 47)	32 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= 35 ,40, 45)	0 participants

Secondary

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.

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 Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	52 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	82 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	38 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	57 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	3 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	25 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	70 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	51 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	83 participants
Maraviroc QD	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	3 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	66 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	59 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	24 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	1 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	80 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	3 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	69 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	48 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	73 participants
Maraviroc BID	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	47 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 2	35 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: greater than or equal to 3	34 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: missing	3 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 0	17 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: greater than or equal to 3	45 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: 1	18 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 0	31 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	PSS: missing	3 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 1	29 participants
Placebo	Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening	GSS: 2	21 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	54.7 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	50.9 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24	60.4 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	57.5 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 24	31.4 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL	Week 48	22.0 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: [1.78, 4.67]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: [2.26, 5.95]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: [2.36, 6.64]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	67.7 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	59.9 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	69.4 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	64.3 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	45.8 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	35.6 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: [1.63, 4.13]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: [1.79, 4.54]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	64.7 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	57.8 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	67.7 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	63.0 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	38.1 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	31.4 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: [1.92, 4.88]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: [2.22, 5.68]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	42.2 percentage of participants
Maraviroc QD	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	41.8 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24	48.5 percentage of participants
Maraviroc BID	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	46.8 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 48	16.1 percentage of participants
Placebo	Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL	Week 24	24.6 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: 0.000695% CI: [1.46, 4.04]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: [1.9, 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	-1.636 log10 copies/mL	Standard Error 0.0789
Maraviroc QD	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-1.556 log10 copies/mL	Standard Error 0.0876
Maraviroc BID	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 24	-1.741 log10 copies/mL	Standard Error 0.0783
Maraviroc BID	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-1.720 log10 copies/mL	Standard Error 0.087
Placebo	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 24	-0.939 log10 copies/mL	Standard Error 0.1103
Placebo	Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels	Week 48	-0.788 log10 copies/mL	Standard Error 0.1227

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: [-0.961, -0.432]

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: [-1.061, -0.474]

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	344.00 days
Maraviroc BID	Time to Virological Failure	NA 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: [0.34, 0.6]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 at 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 Genotypic Susceptibility Scores (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