AEs as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3 = severe: interrupted usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 = very severe: events that were unacceptable and intolerable or were irreversable or caused imminent danger of death. If same participant had more than 1 occurrence in the same preferred term event category, only the most severe (grade 4) occurrence was taken. Treatment-related = investigator assessment of a reasonable possibility that the investigational product caused or contributed to the AE.

Safety analysis set: all participants who were randomized and received at least one dose of study medication.

Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 3, Severe =events that interrupted participants usual daily activity and traditionally required systemic drug therapy or other treatment.

Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.

Laboratory abnormalities as defined by the Division of AIDS (DAIDS) toxicity grading scale: Grade 4, Very Severe = events which were unacceptable and intolerable or were irreversible or caused the participant to be in imminent danger of death.

Safety analysis set. N = number of participants evaluable for laboratory abnormalities (with at least one observation of a laboratory test while on study treatment or during lag time); n = number of participants with at least one observation of given laboratory test while on study treatment or during lag time.

Treatment-emergent AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C adverse events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 30 days after last dose of study drug.

Safety analysis set.

Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline viral load were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study in terms of baseline/nadir CD4 cell counts were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Safety analysis set. Data not analyzed; the number of possible AIDS-related infections and malignancies and limited data collection during the study by time on therapy were such that a summary of AIDS-related infections by this parameter was not clinically meaningful.

Treatment-emergent AEs by gender that occurred up to 30 days after the last dose of study medication.

Safety analysis set; n = number of participants evaluable for adverse events.

Treatment-emergent AEs by race that occurred up to 30 days after the last dose of study medication.

Safety analysis set; n = number of participants evaluable for adverse events.

Treatment-emergent AEs by age that occurred up to 30 days after the last dose of study medication.

Safety analysis set; n = number of participants evaluable for adverse events.

Treatment emergent AEs by hepatis B and hepatitis C serology status that occurred up to 30 days post last dose.

Safety analysis set; n = number of participants evaluable for adverse events. Abbreviations: HBV = hepatitis B virus, HBC = hepatitis C virus.

Defined as HIV-1 RNA levels < 400 Copies/mL or at least 0.5 Log 10-decrease from baseline in HIV-1 RNA levels.

Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Defined as HIV-1 RNA levels < 400 copies/mL or at least 1.0 Log 10-decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of the screening and baseline values if both values were within 1 log10 difference.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Limit of quantification defined as <400 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Limit of quantification defined as <50 copies/mL. Baseline value calculated as average of the screening and baseline values if both values were within 1 log 10 difference.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Change from baseline in cluster of differentiation 4 helper T cells (CD4) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Change from baseline in CD4 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Change from baseline in cluster of differentiation 8 suppressor T cells (CD8) cell count. If baseline value was not available, it was taken from immediate preceding non-missing value.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Change from baseline in CD8 cell count percent . If baseline value was not available, it was taken from immediate preceding non-missing value.

Safety analysis set; n = number of participants contributing to summary statistic at given timepoint.

Computed as time from the first dose of study medication to the loss of virologic response. Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.

Safety analysis set. N = number of participants with virologic failure. For the calculation of the time to virologic failure, any visits with no data were excluded. Participants who were not virologic failures were censored at the last available observation.

Reasons for virologic failure: A) failure to achieve a reduction in HIV-1 RNA>=0.5 log10 copies/ml from baseline (BL) by second viral load determination (unless below level of quantification [LOQ]); B) >=0.5 log10 increase from nadir in HIV-1 RNA after achieving an HIV-1 RNA reduction from BL >0.5 log10 copies/ml ; C) HIV-1 RNA >1000 copies/ml after having achieved an HIV-1 RNA below LOQ.

Safety analysis set; N = number of participants with virologic failure.

Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable [NR]) at Screening (Scr) and time of virologic failure (V fail). Virologic failure defined as: failure to achieve a reduction from baseline (BL) in HIV 1 RNA ≥0.5 log10 copies/mL by second viral load determination (unless viral load was below lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.

Safety analysis set; N = participants with virologic failure (VF). Abbreviations: Scr = screening, R5 = CCR5 tropic HIV-1, X4=CXCR4 tropic HIV-1, DM = dual mixed, NR = non-reportable, Missing = participants with VF who did not have tropism result within specified screening period (Scr missing: -42 days to Day 0) or at the time of VF.

Resistance to maravroc in viruses from participants failing therapy with R5 virus was investigated using the in vitro phenotypic (drug susceptibility) assay. The number of participants who failed with R5 virus were assessed successfully for maraviroc susceptibility at Baseline and Last on--treatment (Week 144). Samples were analyzed for change from Baseline to time of virologic failure in IC 50 and presence of plateau. A maximal percent inhibition (MPI) <95% established as a plateau in inhibition at high concentrations of maraviroc was used to identify viruses which had reduced phenotypic susceptibility to maraviroc.

Safety analysis set. Here, "number of participants analyzed" signifies those participants who were assessed for maraviroc susceptibility.

Virus from participants who experienced virologic failure was analyzed for resistance to maraviroc. Resistance testing was performed on archived samples of participants which were available pre--treatment at time of virologic failure. For participants who met definition of virologic failure during the trial, the sequencing of the V3 loop of HIV--1 viral envelope gp 120 was evaluated to identify any amino acid changes concomitant with decreased susceptibility to maraviroc.

Safety analysis set. Here, "number of participants analyzed" signifies those participants who were assessed for genotypic changes in the V3 Loop of glycoprotein 120 (gp 120).