Trial Outcomes & Findings for Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan) (NCT NCT00864474)

Last Updated: 2020-01-02

Results Overview

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

68 participants

Primary outcome timeframe

From April 2009 to December 2018 (up to approximately 8 years 8 months)

Results posted on

2020-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Celsentri (Maraviroc) Tablets Human immunodeficiency virus (HIV) infected participants, prescribed with Celsentri tablet 150 milligram (mg) depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Age, Continuous	42.31 years STANDARD_DEVIATION 12.37 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	67 Participants n=5 Participants
Race/Ethnicity, Customized Others	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs)	23.53 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Number of Participants With Unknown Adverse Drug Reactions (ADRs)	8 Participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, number analyzed ('n') signifies participants who were evaluable for this outcome measure as per gender.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender Males	23.08 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender Females	33.33 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per age.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age >=15 and less than(<) 65 years	22.22 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age >=65 and less than or equal to (<=) 70 years	40.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per inpatient or outpatient status.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status Inpatient	0.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status Outpatient	15.56 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status Inpatient and outpatient	42.86 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per ethnicity.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity Japanese	23.88 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity Others	0.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of history of therapies for HIV Infection.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection History of Therapies for HIV Infection: Absent	18.75 percentage of participants
Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection History of Therapies for HIV Infection: Present	25.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per duration of HIV infection.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration Unknown	22.58 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration <=1 year	0.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration greater than (>) 4 and <=5 years	0.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration >5 years	50.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of allergies.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies Allergies: Absent	18.52 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies Allergies: Present	38.46 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies Allergies: Unknown	100.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of comorbidities.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities Comorbidities: Present	25.45 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities Comorbidities: Absent	15.38 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of renal impairment.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment Renal Impairment: Absent	20.97 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment Renal Impairment: Present	50.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hepatic impairment.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment Hepatic Impairment: Absent	21.74 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment Hepatic Impairment: Present	27.27 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hemophilia.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia Hemophilia: Absent	22.95 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia Hemophilia: Present	28.57 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean daily dose of Celsentri.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri <2 tablets	0 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri 2 tablets	16.67 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri >2 tablets	35.71 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per number of concomitant anti-HIV treatments use.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use >=4 drugs	27.78 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use 1 drug	0.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use 2 drugs	23.53 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use 3 drugs	25.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per CDC classification.

An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged\>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification CDC category A	20.69 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification CDC category B	20.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification CDC category C	29.03 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification Unknown	0.00 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant therapies.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies Concomitant Therapies: Absent	20.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies Concomitant Therapies: Present	38.46 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant CYP3A enzyme inducer use.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant CYP3A4 enzyme inducer use are reported to assess presence or absence of concomitant CYP3A enzyme inducer use as a risk factor for ADR. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducer for enzyme CYP3A4.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri CYP3A Enzyme Inducer Use: Absent	21.82 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri CYP3A Enzyme Inducer Use: Present	30.77 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per total number of days of administration of Celsentri.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri 2 to <=180 days	8.82 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri > 180 and <=365 days	1.67 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri > 365 and <=730 days	7.69 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri > 730 and <= 2704 days	8.57 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean total dose of Celsentri.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri 4 to <=360 tablets	7.35 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri > 360 and <=730 tablets	3.28 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri > 730 and <=1460 tablets	0.00 percentage of participants
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri > 1460 and <=21632 tablets	17.07 percentage of participants

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function	0 ADRs

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function	3 ADRs

PRIMARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The safety analysis set included all participants who met the criteria for participants and were confirmed to have received at least one dose of Celsentri.

An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=68 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects	0 ADRs

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.

HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies per milliliter (copies/mL). The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 0 (Baseline)	3.1 Log HIV-RNA copies/milliliter(mL) Standard Deviation 1.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 3	1.9 Log HIV-RNA copies/milliliter(mL) Standard Deviation 1.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 6	1.6 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.6
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 9	1.4 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 12	1.9 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.8
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 15	1.7 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.5
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 18	1.8 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 21	1.9 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.6
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 24	1.5 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 27	1.4 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 30	1.7 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 33	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.1
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 36	1.4 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.2
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 39	1.4 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 42	1.5 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 45	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 48	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 51	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.1
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 54	219.0 Log HIV-RNA copies/milliliter(mL) Standard Deviation 42.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 57	1294.5 Log HIV-RNA copies/milliliter(mL) Standard Deviation 1096.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 60	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 63	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 69	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 75	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 78	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Males: Month 84	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Females: Month 0 (Baseline)	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Females: Month 3	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender Females: Month 15	1.3 Log HIV-RNA copies/milliliter(mL) Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom info sirmation about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.

CD4+ Lymphocyte were counted by CD4 cells per cubic millimeter (cells/mm\^3). CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 0 (Baseline)	301.2 CD4 cells/mm^3 Standard Deviation 244.5
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 3	318.2 CD4 cells/mm^3 Standard Deviation 221.5
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 6	319.2 CD4 cells/mm^3 Standard Deviation 201.2
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 9	405.7 CD4 cells/mm^3 Standard Deviation 197.6
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 12	384.0 CD4 cells/mm^3 Standard Deviation 228.7
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 15	440.9 CD4 cells/mm^3 Standard Deviation 259.2
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 18	393.3 CD4 cells/mm^3 Standard Deviation 244.8
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 21	464.7 CD4 cells/mm^3 Standard Deviation 302.2
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 24	427.3 CD4 cells/mm^3 Standard Deviation 282.6
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 27	612.4 CD4 cells/mm^3 Standard Deviation 308.7
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 30	376.0 CD4 cells/mm^3 Standard Deviation 161.1
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 33	447.5 CD4 cells/mm^3 Standard Deviation 243.0
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 36	500.5 CD4 cells/mm^3 Standard Deviation 175.3
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 39	554.4 CD4 cells/mm^3 Standard Deviation 252.1
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 42	794.9 CD4 cells/mm^3 Standard Deviation 326.4
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 45	822.8 CD4 cells/mm^3 Standard Deviation 429.8
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 48	603.0 CD4 cells/mm^3 Standard Deviation 368.4
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 51	637.1 CD4 cells/mm^3 Standard Deviation 401.5
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 54	219.0 CD4 cells/mm^3 Standard Deviation 42.4
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 57	1294.5 CD4 cells/mm^3 Standard Deviation 1096.7
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 60	652.0 CD4 cells/mm^3 Standard Deviation 711.3
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 63	445.0 CD4 cells/mm^3 Standard Deviation 377.6
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 69	1006.0 CD4 cells/mm^3 Standard Deviation 598.2
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 75	969.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 78	787.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Males: Month 84	934.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Females: Month 0 (Baseline)	335.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Females: Month 3	122.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender Females: Month 15	197.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints.

HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 54	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 0 (Baseline)	2.8 Log HIV-RNA copies/mL Standard Deviation 1.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 3	1.9 Log HIV-RNA copies/mL Standard Deviation 1.1
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 6	1.8 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 9	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 12	2.1 Log HIV-RNA copies/mL Standard Deviation 0.9
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 15	1.6 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 18	1.8 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 21	2.1 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 24	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 27	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 30	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 36	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 39	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 42	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 51	1.4 Log HIV-RNA copies/mL Standard Deviation 0.1
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 75	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 78	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Present: Month 84	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 0 (Baseline)	3.8 Log HIV-RNA copies/mL Standard Deviation 1.6
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 3	1.8 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 6	1.4 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 9	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 12	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 15	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 18	2.4 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 21	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 27	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 36	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 39	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 42	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard Deviation cannot be calculated as CD4 cell count is available for 1 participant only.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities Comorbidities-Absent: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 18	301.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 0 (Baseline)	294.2 CD4 cells/mm^3 Standard Deviation 249.5
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 3	282.0 CD4 cells/mm^3 Standard Deviation 205.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 6	284.9 CD4 cells/mm^3 Standard Deviation 196.2
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 9	361.5 CD4 cells/mm^3 Standard Deviation 199.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 12	303.3 CD4 cells/mm^3 Standard Deviation 170.9
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 15	422.9 CD4 cells/mm^3 Standard Deviation 286.3
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 18	401.6 CD4 cells/mm^3 Standard Deviation 254.9
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 21	308.4 CD4 cells/mm^3 Standard Deviation 221.7
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 24	427.3 CD4 cells/mm^3 Standard Deviation 282.6
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 27	558.7 CD4 cells/mm^3 Standard Deviation 399.4
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 30	376.0 CD4 cells/mm^3 Standard Deviation 161.1
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 33	357.0 CD4 cells/mm^3 Standard Deviation 211.6
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 36	415.7 CD4 cells/mm^3 Standard Deviation 54.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 39	476.4 CD4 cells/mm^3 Standard Deviation 243.2
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 42	813.2 CD4 cells/mm^3 Standard Deviation 419.6
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 45	1017.5 CD4 cells/mm^3 Standard Deviation 579.1
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 48	603.0 CD4 cells/mm^3 Standard Deviation 451.2
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 51	714.1 CD4 cells/mm^3 Standard Deviation 454.1
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 54	219.0 CD4 cells/mm^3 Standard Deviation 42.4
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 57	2070.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 60	652.0 CD4 cells/mm^3 Standard Deviation 711.3
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 63	178.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 69	1429.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 75	969.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 78	787.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Present: Month 84	934.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 0 (Baseline)	325.6 CD4 cells/mm^3 Standard Deviation 226.1
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 3	388.0 CD4 cells/mm^3 Standard Deviation 262.5
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 6	401.4 CD4 cells/mm^3 Standard Deviation 210.1
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 9	523.7 CD4 cells/mm^3 Standard Deviation 167.4
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 12	707.0 CD4 cells/mm^3 Standard Deviation 75.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 15	419.7 CD4 cells/mm^3 Standard Deviation 167.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 21	777.5 CD4 cells/mm^3 Standard Deviation 125.2
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 27	693.0 CD4 cells/mm^3 Standard Deviation 75.5
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 33	605.8 CD4 cells/mm^3 Standard Deviation 234.0
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 36	755.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 39	788.5 CD4 cells/mm^3 Standard Deviation 55.9
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 42	758.5 CD4 cells/mm^3 Standard Deviation 17.7
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 45	628.0 CD4 cells/mm^3 Standard Deviation 258.8
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 48	603.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 51	406.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 57	519.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities-Absent: Month 63	712.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities Comorbidities -Absent: Month 69	583.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as follows: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute (primary) HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged \>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 0 (Baseline)	3.4 Log HIV-RNA copies/mL Standard Deviation 1.7
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 3	1.6 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 6	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 9	1.3 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 12	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 15	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 18	1.6 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 21	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 24	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 27	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 36	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 39	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 42	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 75	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 78	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 84	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 0 (Baseline)	1.6 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 3	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 6	1.5 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 15	2.1 Log HIV-RNA copies/mL Standard Deviation 1.2
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 18	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 24	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 27	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 30	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 39	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 42	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 0 (Baseline)	3.0 Log HIV-RNA copies/mL Standard Deviation 1.8
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 3	2.3 Log HIV-RNA copies/mL Standard Deviation 1.5
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 6	1.9 Log HIV-RNA copies/mL Standard Deviation 0.9
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 9	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 12	2.3 Log HIV-RNA copies/mL Standard Deviation 1.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 15	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 18	2.0 Log HIV-RNA copies/mL Standard Deviation 0.8
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 21	2.1 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 24	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 27	1.8 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 30	1.9 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 33	1.4 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 36	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 39	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 42	1.9 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 51	1.5 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 54	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints.

CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged\>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the AIDS diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 48	596.0 CD4 cells/mm^3 Standard Deviation 9.9
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 51	609.0 CD4 cells/mm^3 Standard Deviation 287.1
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 57	519.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 63	712.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 69	583.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 75	969.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 78	787.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A : Month 84	934.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 0 (Baseline)	264.3 CD4 cells/mm^3 Standard Deviation 221.4
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 3	227.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 6	122.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 15	447.5 CD4 cells/mm^3 Standard Deviation 337.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 18	371.0 CD4 cells/mm^3 Standard Deviation 319.6
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 24	207.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 27	180.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 30	218.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 33	137.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 39	201.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 42	1221.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 45	1427.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 48	610.0 CD4 cells/mm^3 Standard Deviation 637.8
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 51	219.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 60	149.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category B: Month 63	178.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 0 (Baseline)	255.9 CD4 cells/mm^3 Standard Deviation 268.5
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 3	165.0 CD4 cells/mm^3 Standard Deviation 129.4
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 6	207.0 CD4 cells/mm^3 Standard Deviation 166.7
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 9	315.3 CD4 cells/mm^3 Standard Deviation 264.1
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 12	243.2 CD4 cells/mm^3 Standard Deviation 155.8
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 15	389.2 CD4 cells/mm^3 Standard Deviation 354.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 18	396.1 CD4 cells/mm^3 Standard Deviation 276.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 21	308.4 CD4 cells/mm^3 Standard Deviation 221.7
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 24	412.3 CD4 cells/mm^3 Standard Deviation 313.9
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 27	411.7 CD4 cells/mm^3 Standard Deviation 224.0
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 30	455.0 CD4 cells/mm^3 Standard Deviation 120.2
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 33	398.8 CD4 cells/mm^3 Standard Deviation 265.6
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 36	384.5 CD4 cells/mm^3 Standard Deviation 3.5
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 39	519.1 CD4 cells/mm^3 Standard Deviation 259.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 42	848.8 CD4 cells/mm^3 Standard Deviation 360.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 51	1111.2 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 54	219.0 CD4 cells/mm^3 Standard Deviation 42.4
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 57	2070.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 60	1155.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category C: Month 69	1429.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 0 (Baseline)	347.0 CD4 cells/mm^3 Standard Deviation 222.5
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 3	416.2 CD4 cells/mm^3 Standard Deviation 221.9
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 6	428.3 CD4 cells/mm^3 Standard Deviation 175.6
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 9	457.4 CD4 cells/mm^3 Standard Deviation 147.2
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 12	524.8 CD4 cells/mm^3 Standard Deviation 209.5
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 15	441.2 CD4 cells/mm^3 Standard Deviation 183.8
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 18	401.3 CD4 cells/mm^3 Standard Deviation 221.3
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 21	777.5 CD4 cells/mm^3 Standard Deviation 125.2
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 24	567.5 CD4 cells/mm^3 Standard Deviation 307.6
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 27	784.8 CD4 cells/mm^3 Standard Deviation 232.9
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category Month 33	531.7 CD4 cells/mm^3 Standard Deviation 214.6
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 36	616.5 CD4 cells/mm^3 Standard Deviation 195.9
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 39	719.3 CD4 cells/mm^3 Standard Deviation 126.1
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 42	617.0 CD4 cells/mm^3 Standard Deviation 245.4
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification CDC category A: Month 45	621.3 CD4 cells/mm^3 Standard Deviation 183.4

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 0 (Baseline)	2.4 Log HIV-RNA copies/mL Standard Deviation 1.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 3	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 6	1.7 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 9	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 12	1.8 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 15	1.6 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 18	1.8 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 21	2.1 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 24	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 27	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 30	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 36	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 39	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 42	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation 0.1
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 54	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 75	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 78	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Present: Month 84	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 0 (Baseline)	4.7 Log HIV-RNA copies/mL Standard Deviation 1.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 3	2.2 Log HIV-RNA copies/mL Standard Deviation 1.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 6	1.6 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 9	1.6 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 12	2.0 Log HIV-RNA copies/mL Standard Deviation 1.1
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 15	1.7 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 21	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 24	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 27	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 36	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 39	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection Absent: Month 42	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.

CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 42	746.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 0	334.8 CD4 cells/mm^3 Standard Deviation 266.2
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 3	263.0 CD4 cells/mm^3 Standard Deviation 203.8
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 6	297.6 CD4 cells/mm^3 Standard Deviation 214.5
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 9	393.7 CD4 cells/mm^3 Standard Deviation 216.8
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 12	373.2 CD4 cells/mm^3 Standard Deviation 176.2
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 15	443.2 CD4 cells/mm^3 Standard Deviation 240.1
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 18	393.3 CD4 cells/mm^3 Standard Deviation 244.8
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 21	520.6 CD4 cells/mm^3 Standard Deviation 253.8
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 24	496.2 CD4 cells/mm^3 Standard Deviation 236.5
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 27	607.1 CD4 cells/mm^3 Standard Deviation 327.0
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 30	376.0 CD4 cells/mm^3 Standard Deviation 161.1
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 33	412.1 CD4 cells/mm^3 Standard Deviation 224.3
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 36	540.0 CD4 cells/mm^3 Standard Deviation 191.7
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 39	599.9 CD4 cells/mm^3 Standard Deviation 234.2
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 42	804.7 CD4 cells/mm^3 Standard Deviation 363.9
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 45	822.8 CD4 cells/mm^3 Standard Deviation 429.8
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 48	603.0 CD4 cells/mm^3 Standard Deviation 368.4
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 51	637.1 CD4 cells/mm^3 Standard Deviation 401.5
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 54	219.0 CD4 cells/mm^3 Standard Deviation 42.4
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 57	1294.5 CD4 cells/mm^3 Standard Deviation 1096.7
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 60	652.0 CD4 cells/mm^3 Standard Deviation 711.3
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 63	445.0 CD4 cells/mm^3 Standard Deviation 377.6
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 69	1006.0 CD4 cells/mm^3 Standard Deviation 598.2
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 75	969.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 78	787.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Present: Month 84	934.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 0	225.6 CD4 cells/mm^3 Standard Deviation 153.5
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 3	382.2 CD4 cells/mm^3 Standard Deviation 237.0
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 6	371.0 CD4 cells/mm^3 Standard Deviation 175.1
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 9	426.8 CD4 cells/mm^3 Standard Deviation 187.7
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 12	394.8 CD4 cells/mm^3 Standard Deviation 293.9
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 15	306.5 CD4 cells/mm^3 Standard Deviation 430.6
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 21	353.0 CD4 cells/mm^3 Standard Deviation 475.2
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 24	14.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 27	660.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 33	801.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 36	382.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection Absent: Month 39	236.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.

HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 24	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 18	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 21	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 36	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 39	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 0 (Baseline)	3.6 Log HIV-RNA copies/mL Standard Deviation 2.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 3	2.4 Log HIV-RNA copies/mL Standard Deviation 2.1
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 6	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 9	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 12	3.9 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 15	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 42	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 75	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 78	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 84	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 0 (Baseline)	3.0 Log HIV-RNA copies/mL Standard Deviation 1.6
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 3	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 6	1.7 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 9	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 12	1.7 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 15	1.6 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 18	1.9 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 21	2.0 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 24	1.6 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 27	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 30	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 36	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 39	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 42	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 51	1.4 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 54	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.

CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of many of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=63 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 9	223.0 CD4 cells/mm^3 Standard Deviation 183.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 0 (Baseline)	200.7 CD4 cells/mm^3 Standard Deviation 220.4
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 3	193.0 CD4 cells/mm^3 Standard Deviation 217.3
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 6	212.0 CD4 cells/mm^3 Standard Deviation 233.8
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 12	4.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 15	231.3 CD4 cells/mm^3 Standard Deviation 247.2
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 18	248.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 21	17.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 24	182.0 CD4 cells/mm^3 Standard Deviation 237.6
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 33	367.7 CD4 cells/mm^3 Standard Deviation 29.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 36	478.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 39	581.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 42	334.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 45	526.5 CD4 cells/mm^3 Standard Deviation 115.3
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 48	589.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 51	609.0 CD4 cells/mm^3 Standard Deviation 287.1
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 57	519.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 63	712.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 69	583.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 75	969.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 78	787.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Present: Month 84	934.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 0 (Baseline)	320.0 CD4 cells/mm^3 Standard Deviation 243.6
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 3	342.1 CD4 cells/mm^3 Standard Deviation 215.8
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 6	342.1 CD4 cells/mm^3 Standard Deviation 195.4
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 9	474.3 CD4 cells/mm^3 Standard Deviation 163.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 12	426.2 CD4 cells/mm^3 Standard Deviation 197.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 15	507.0 CD4 cells/mm^3 Standard Deviation 223.5
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 18	406.5 CD4 cells/mm^3 Standard Deviation 252.2
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 21	554.3 CD4 cells/mm^3 Standard Deviation 232.4
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 24	525.4 CD4 cells/mm^3 Standard Deviation 252.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 27	612.4 CD4 cells/mm^3 Standard Deviation 308.7
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 30	376.0 CD4 cells/mm^3 Standard Deviation 161.1
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 33	477.4 CD4 cells/mm^3 Standard Deviation 283.5
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 36	508.0 CD4 cells/mm^3 Standard Deviation 213.9
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 39	550.6 CD4 cells/mm^3 Standard Deviation 272.1
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 42	887.1 CD4 cells/mm^3 Standard Deviation 263.5
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 45	1119.0 CD4 cells/mm^3 Standard Deviation 435.6
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 48	607.7 CD4 cells/mm^3 Standard Deviation 451.0
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 51	665.1 CD4 cells/mm^3 Standard Deviation 630.9
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 54	219.0 CD4 cells/mm^3 Standard Deviation 42.4
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 57	2070.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 60	652.0 CD4 cells/mm^3 Standard Deviation 711.3
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 63	178.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri Absent: Month 69	1429.0 CD4 cells/mm^3 Standard Deviation NA Standard deviation could not be calculated since only one participant was available for analysis.

SECONDARY outcome

Timeframe: From April 2009 to December 2018 (up to approximately 8 years 8 months)

Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

CCR5= C-C chemokine receptor type 5 and CXCR4= C-X-C chemokine receptor type 4. Tropism switch is the mutation of CCR5-tropic HIV-1 to a CXCR4-using virus.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=32 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants	0 Participants

SECONDARY outcome

Timeframe: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84

Population: The efficacy analysis set. Here, "Overall Number of Participants Analyzed" included participants evaluable for this measure. 'n' signifies participants who were evaluable for this measure at specified timepoints.

Outcome measures

Outcome measures
Measure	Celsentri (Maraviroc) Tablets n=40 Participants HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 54	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 57	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 60	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At baseline	3.1 Log HIV-RNA copies/mL Standard Deviation 1.7
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 3	1.8 Log HIV-RNA copies/mL Standard Deviation 1.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 6	1.6 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 9	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 12	1.9 Log HIV-RNA copies/mL Standard Deviation 0.8
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 15	1.6 Log HIV-RNA copies/mL Standard Deviation 0.5
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 18	1.8 Log HIV-RNA copies/mL Standard Deviation 0.7
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 21	1.9 Log HIV-RNA copies/mL Standard Deviation 0.6
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 24	1.5 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 27	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 30	1.7 Log HIV-RNA copies/mL Standard Deviation 0.4
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 33	1.3 Log HIV-RNA copies/mL Standard Deviation 0.1
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 36	1.4 Log HIV-RNA copies/mL Standard Deviation 0.2
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 39	1.4 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 42	1.5 Log HIV-RNA copies/mL Standard Deviation 0.3
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 45	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 48	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 51	1.3 Log HIV-RNA copies/mL Standard Deviation 0.1
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 63	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 69	1.3 Log HIV-RNA copies/mL Standard Deviation 0.0
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 75	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard Deviation could not be calculated as only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 78	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard Deviation could not be calculated as only one participant was available for analysis.
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri At Month 84	1.3 Log HIV-RNA copies/mL Standard Deviation NA Standard Deviation could not be calculated as only one participant was available for analysis.

Adverse Events

Celsentri (Maraviroc) Tablets

Serious events: 17 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Celsentri (Maraviroc) Tablets n=68 participants at risk HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Eye disorders Glaucoma	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Eye disorders Necrotising retinitis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Eye disorders Vitreous haemorrhage	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Intra-abdominal haemorrhage	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Oesophageal varices haemorrhage	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Immune system disorders Immune reconstitution inflammatory syndrome	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Aspergillus infection	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Cellulitis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Helicobacter infection	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Pneumocystis jirovecii pneumonia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Progressive multifocal leukoencephalopathy	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Syphilis	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Urinary tract infection	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Injury, poisoning and procedural complications Fracture	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Injury, poisoning and procedural complications Heat illness	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Injury, poisoning and procedural complications Spinal compression fracture	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Injury, poisoning and procedural complications Subdural haematoma	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Diabetes mellitus	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Musculoskeletal and connective tissue disorders Haemarthrosis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Nervous system disorders Cerebral haemorrhage	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Nervous system disorders Cerebral infarction	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Psychiatric disorders Depressive symptom	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Psychiatric disorders Psychiatric symptom	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Renal and urinary disorders Calculus urinary	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Renal and urinary disorders Prerenal failure	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Renal and urinary disorders Renal impairment	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Renal and urinary disorders Renal tubular disorder	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

Other adverse events

Other adverse events
Measure	Celsentri (Maraviroc) Tablets n=68 participants at risk HIV infected participants, prescribed with Celsentri tablet 150 mg depending upon physician's discretion, within the duration from April 2009 to March 2017 were enrolled in the study. Frequency and duration of taking Celsentri tablet were according to package insert, "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food". The participants in this study were retrospectively observed from the first dosing date of Celsentri tablet to the completion of study or treatment discontinuation due to reasons such as participant's death or hospital transfer, within the duration from April 2009 to December 2018.
Blood and lymphatic system disorders Anaemia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Diarrhoea	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Dry mouth	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Faeces soft	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Gastrointestinal disorders Nausea	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
General disorders Malaise	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Hepatobiliary disorders Hepatic function abnormal	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Hepatobiliary disorders Hepatic steatosis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Hepatobiliary disorders Liver disorder	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Dermatophytosis of nail	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Gastroenteritis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Herpes zoster	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Nasopharyngitis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Infections and infestations Oral candidiasis	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Investigations White blood cell count increased	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Dyslipidaemia	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hyperlipidaemia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hyperphosphatasaemia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.9% 4/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hyperuricaemia	2.9% 2/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Metabolism and nutrition disorders Obesity	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Musculoskeletal and connective tissue disorders Osteopenia	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Nervous system disorders Cerebral arteriosclerosis	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Nervous system disorders Dizziness	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Nervous system disorders Headache	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Skin and subcutaneous tissue disorders Drug eruption	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Skin and subcutaneous tissue disorders Pruritus	1.5% 1/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
Vascular disorders Hypertension	4.4% 3/68 • From April 2009 to December 2018 (up to approximately 8 years 8 months) Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another, or a participant may have experienced both a serious and non-serious event. The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER