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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00864474
• Collaborator: Pfizer (Industry)
• Enrollment: 68
• Actual Duration (Months): 104.8

Study Details

Study Description

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Condition or Disease	Intervention/Treatment	Phase
CCR5-tropic HIV-1 Infection	Drug: CELSENTRI® Tablets

Detailed Description

All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MARAVIROC (REGULATORY POST MARKETING COMMITMENT PLAN).
• Actual Study Start Date: Mar 31, 2010
• Actual Primary Completion Date: Dec 24, 2018
• Actual Study Completion Date: Dec 24, 2018

Arms and Interventions

Arm

Intervention/Treatment

Maraviroc Tablets Patients administered.

Drug: CELSENTRI® Tablets; CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "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".; Other Names: CELSENTRI® Tablets, maraviroc, Selzentry

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Adverse Drug Reactions (ADRs) [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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.

2. Number of Participants With Unknown Adverse Drug Reactions (ADRs) [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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. Unknown ADRs were the ADRs those were not listed on the package insert.

3. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 gender are reported to assess gender as a risk factor for ADR.

4. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 age are reported to assess age as a risk factor for ADR. ">=" refers to greater than or equal to.

5. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR.

6. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 ethnicity are reported to assess ethnicity as a risk factor for ADR.

7. Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR.

8. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known.

9. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

   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 allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known.

10. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

11. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR.

12. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR.

13. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

14. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.

15. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri.

16. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

17. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

18. 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 [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

19. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR.

20. Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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 mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.

21. Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

22. Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

23. Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

Secondary Outcome Measures

1. Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender [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]

   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.

2. Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender [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+ 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.

3. Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities [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]

   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.

4. Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities [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.

5. Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification [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.

6. Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification [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 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.

7. Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection [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]

   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.

8. Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection [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 a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning.

9. 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 [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]

   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.

10. Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri [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. 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.

11. Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants [From April 2009 to December 2018 (up to approximately 8 years 8 months)]

    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.

12. Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered CELSENTRI® Tablets.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ViiV Healthcare
• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Jun 1, 2015
• Statistical Analysis Plan - Dec 1, 2018

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT00864474
• Other Study ID Numbers: A4001093
• First Posted: Mar 18, 2009
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Infections; Maraviroc

Study Results

Participant Flow

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Period Title: Overall Study
STARTED	68
COMPLETED	68
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Overall Participants	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.31 (12.37)
Sex: Female, Male (Count of Participants)
Female	3 4.4%
Male	65 95.6%
Race/Ethnicity, Customized (Count of Participants)
Japanese	67 98.5%
Others	1 1.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs)
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Number [percentage of participants]	23.53 34.6%

2. Primary Outcome

Title	Number of Participants With Unknown Adverse Drug Reactions (ADRs)
Description	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. Unknown ADRs were the ADRs those were not listed on the package insert.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Count of Participants [Participants]	8 11.8%

3. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender
Description	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 gender are reported to assess gender as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Males	23.08 33.9%
Females	33.33 49%

4. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age
Description	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 age are reported to assess age as a risk factor for ADR. ">=" refers to greater than or equal to.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
>=15 and less than(<) 65 years	22.22 32.7%
>=65 and less than or equal to (<=) 70 years	40.00 58.8%

5. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status
Description	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 inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Inpatient	0.00 0%
Outpatient	15.56 22.9%
Inpatient and outpatient	42.86 63%

6. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity
Description	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 ethnicity are reported to assess ethnicity as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Japanese	23.88 35.1%
Others	0.00 0%

7. Primary Outcome

Title	Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection
Description	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 history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
History of Therapies for HIV Infection: Absent	18.75 27.6%
History of Therapies for HIV Infection: Present	25.00 36.8%

8. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration
Description	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 HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
<=1 year	0.00 0%
greater than (>) 4 and <=5 years	0.00 0%
>5 years	50.00 73.5%
Unknown	22.58 33.2%

9. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies
Description	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 allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Allergies: Absent	18.52 27.2%
Allergies: Present	38.46 56.6%
Allergies: Unknown	100.00 147.1%

10. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Comorbidities: Absent	15.38 22.6%
Comorbidities: Present	25.45 37.4%

11. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment
Description	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 renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Renal Impairment: Absent	20.97 30.8%
Renal Impairment: Present	50.00 73.5%

12. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment
Description	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 hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Hepatic Impairment: Absent	21.74 32%
Hepatic Impairment: Present	27.27 40.1%

13. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Hemophilia: Absent	22.95 33.8%
Hemophilia: Present	28.57 42%

14. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri
Description	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 mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
<2 tablets	0 0%
2 tablets	16.67 24.5%
>2 tablets	35.71 52.5%

15. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use
Description	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 number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
1 drug	0.00 0%
2 drugs	23.53 34.6%
3 drugs	25.00 36.8%
>=4 drugs	27.78 40.9%

16. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
CDC category A	20.69 30.4%
CDC category B	20.00 29.4%
CDC category C	29.03 42.7%
Unknown	0.00 0%

17. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Concomitant Therapies: Absent	20.00 29.4%
Concomitant Therapies: Present	38.46 56.6%

18. Primary Outcome

Title	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
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
CYP3A Enzyme Inducer Use: Absent	21.82 32.1%
CYP3A Enzyme Inducer Use: Present	30.77 45.3%

19. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri
Description	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 total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
2 to <=180 days	8.82 13%
> 180 and <=365 days	1.67 2.5%
> 365 and <=730 days	7.69 11.3%
> 730 and <= 2704 days	8.57 12.6%

20. Primary Outcome

Title	Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri
Description	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 mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
4 to <=360 tablets	7.35 10.8%
> 360 and <=730 tablets	3.28 4.8%
> 730 and <=1460 tablets	0.00 0%
> 1460 and <=21632 tablets	17.07 25.1%

21. Primary Outcome

Title	Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Number [ADRs]	0

22. Primary Outcome

Title	Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Number [ADRs]	3

23. Primary Outcome

Title	Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	68
Number [ADRs]	0

24. Secondary Outcome

Title	Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Males: Month 0 (Baseline)	3.1 (1.7)
Males: Month 3	1.9 (1.0)
Males: Month 6	1.6 (0.6)
Males: Month 9	1.4 (0.3)
Males: Month 12	1.9 (0.8)
Males: Month 15	1.7 (0.5)
Males: Month 18	1.8 (0.7)
Males: Month 21	1.9 (0.6)
Males: Month 24	1.5 (0.4)
Males: Month 27	1.4 (0.3)
Males: Month 30	1.7 (0.4)
Males: Month 33	1.3 (0.1)
Males: Month 36	1.4 (0.2)
Males: Month 39	1.4 (0.3)
Males: Month 42	1.5 (0.3)
Males: Month 45	1.3 (0.0)
Males: Month 48	1.3 (0.0)
Males: Month 51	1.3 (0.1)
Males: Month 54	219.0 (42.4)
Males: Month 57	1294.5 (1096.7)
Males: Month 60	1.3 (0.0)
Males: Month 63	1.3 (0.0)
Males: Month 69	1.3 (0.0)
Males: Month 75	1.3 (NA)
Males: Month 78	1.3 (NA)
Males: Month 84	1.3 (NA)
Females: Month 0 (Baseline)	1.3 (NA)
Females: Month 3	1.3 (NA)
Females: Month 15	1.3 (NA)

25. Secondary Outcome

Title	Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Males: Month 0 (Baseline)	301.2 (244.5)
Males: Month 3	318.2 (221.5)
Males: Month 6	319.2 (201.2)
Males: Month 9	405.7 (197.6)
Males: Month 12	384.0 (228.7)
Males: Month 15	440.9 (259.2)
Males: Month 18	393.3 (244.8)
Males: Month 21	464.7 (302.2)
Males: Month 24	427.3 (282.6)
Males: Month 27	612.4 (308.7)
Males: Month 30	376.0 (161.1)
Males: Month 33	447.5 (243.0)
Males: Month 36	500.5 (175.3)
Males: Month 39	554.4 (252.1)
Males: Month 42	794.9 (326.4)
Males: Month 45	822.8 (429.8)
Males: Month 48	603.0 (368.4)
Males: Month 51	637.1 (401.5)
Males: Month 54	219.0 (42.4)
Males: Month 57	1294.5 (1096.7)
Males: Month 60	652.0 (711.3)
Males: Month 63	445.0 (377.6)
Males: Month 69	1006.0 (598.2)
Males: Month 75	969.0 (NA)
Males: Month 78	787.0 (NA)
Males: Month 84	934.0 (NA)
Females: Month 0 (Baseline)	335.0 (NA)
Females: Month 3	122.0 (NA)
Females: Month 15	197.0 (NA)

26. Secondary Outcome

Title	Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Comorbidities-Present: Month 0 (Baseline)	2.8 (1.7)
Comorbidities-Present: Month 3	1.9 (1.1)
Comorbidities-Present: Month 6	1.8 (0.7)
Comorbidities-Present: Month 9	1.5 (0.3)
Comorbidities-Present: Month 12	2.1 (0.9)
Comorbidities-Present: Month 15	1.6 (0.6)
Comorbidities-Present: Month 18	1.8 (0.7)
Comorbidities-Present: Month 21	2.1 (0.7)
Comorbidities-Present: Month 24	1.5 (0.4)
Comorbidities-Present: Month 27	1.5 (0.4)
Comorbidities-Present: Month 30	1.7 (0.4)
Comorbidities-Present: Month 33	1.3 (0.2)
Comorbidities-Present: Month 36	1.4 (0.3)
Comorbidities-Present: Month 39	1.5 (0.4)
Comorbidities-Present: Month 42	1.6 (0.4)
Comorbidities-Present: Month 45	1.3 (0.0)
Comorbidities-Present: Month 48	1.3 (0.0)
Comorbidities-Present: Month 51	1.4 (0.1)
Comorbidities-Present: Month 54	1.3 (0.0)
Comorbidities-Present: Month 57	1.3 (NA)
Comorbidities-Present: Month 60	1.3 (0.0)
Comorbidities-Present: Month 63	1.3 (NA)
Comorbidities-Present: Month 69	1.3 (NA)
Comorbidities-Present: Month 75	1.3 (NA)
Comorbidities-Present: Month 78	1.3 (NA)
Comorbidities-Present: Month 84	1.3 (NA)
Comorbidities-Absent: Month 0 (Baseline)	3.8 (1.6)
Comorbidities-Absent: Month 3	1.8 (0.3)
Comorbidities-Absent: Month 6	1.4 (0.2)
Comorbidities-Absent: Month 9	1.3 (0.0)
Comorbidities-Absent: Month 12	1.3 (0.0)
Comorbidities-Absent: Month 15	1.7 (0.4)
Comorbidities-Absent: Month 18	2.4 (NA)
Comorbidities-Absent: Month 21	1.5 (0.3)
Comorbidities-Absent: Month 27	1.3 (0.0)
Comorbidities-Absent: Month 33	1.3 (0.0)
Comorbidities-Absent: Month 36	1.3 (NA)
Comorbidities-Absent: Month 39	1.3 (0.0)
Comorbidities-Absent: Month 42	1.3 (0.0)
Comorbidities-Absent: Month 45	1.3 (0.0)
Comorbidities-Absent: Month 48	1.3 (NA)
Comorbidities-Absent: Month 51	1.3 (NA)
Comorbidities-Absent: Month 57	1.3 (NA)
Comorbidities-Absent: Month 63	1.3 (NA)
Comorbidities-Absent: Month 69	1.3 (NA)

27. Secondary Outcome

Title	Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Comorbidities-Present: Month 0 (Baseline)	294.2 (249.5)
Comorbidities-Present: Month 3	282.0 (205.0)
Comorbidities-Present: Month 6	284.9 (196.2)
Comorbidities-Present: Month 9	361.5 (199.0)
Comorbidities-Present: Month 12	303.3 (170.9)
Comorbidities-Present: Month 15	422.9 (286.3)
Comorbidities-Present: Month 18	401.6 (254.9)
Comorbidities-Present: Month 21	308.4 (221.7)
Comorbidities-Present: Month 24	427.3 (282.6)
Comorbidities-Present: Month 27	558.7 (399.4)
Comorbidities-Present: Month 30	376.0 (161.1)
Comorbidities-Present: Month 33	357.0 (211.6)
Comorbidities-Present: Month 36	415.7 (54.0)
Comorbidities-Present: Month 39	476.4 (243.2)
Comorbidities-Present: Month 42	813.2 (419.6)
Comorbidities-Present: Month 45	1017.5 (579.1)
Comorbidities-Present: Month 48	603.0 (451.2)
Comorbidities-Present: Month 51	714.1 (454.1)
Comorbidities-Present: Month 54	219.0 (42.4)
Comorbidities-Present: Month 57	2070.0 (NA)
Comorbidities-Present: Month 60	652.0 (711.3)
Comorbidities-Present: Month 63	178.0 (NA)
Comorbidities-Present: Month 69	1429.0 (NA)
Comorbidities-Present: Month 75	969.0 (NA)
Comorbidities-Present: Month 78	787.0 (NA)
Comorbidities-Present: Month 84	934.0 (NA)
Comorbidities-Absent: Month 0 (Baseline)	325.6 (226.1)
Comorbidities-Absent: Month 3	388.0 (262.5)
Comorbidities-Absent: Month 6	401.4 (210.1)
Comorbidities-Absent: Month 9	523.7 (167.4)
Comorbidities-Absent: Month 12	707.0 (75.0)
Comorbidities-Absent: Month 15	419.7 (167.0)
Comorbidities-Absent: Month 18	301.0 (NA)
Comorbidities-Absent: Month 21	777.5 (125.2)
Comorbidities-Absent: Month 27	693.0 (75.5)
Comorbidities-Absent: Month 33	605.8 (234.0)
Comorbidities-Absent: Month 36	755.0 (NA)
Comorbidities-Absent: Month 39	788.5 (55.9)
Comorbidities-Absent: Month 42	758.5 (17.7)
Comorbidities-Absent: Month 45	628.0 (258.8)
Comorbidities-Absent: Month 48	603.0 (NA)
Comorbidities-Absent: Month 51	406.0 (NA)
Comorbidities-Absent: Month 57	519.0 (NA)
Comorbidities-Absent: Month 63	712.0 (NA)
Comorbidities -Absent: Month 69	583.0 (NA)

28. Secondary Outcome

Title	Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
CDC category A: Month 0 (Baseline)	3.4 (1.7)
CDC category A: Month 3	1.6 (0.3)
CDC category A: Month 6	1.5 (0.3)
CDC category A: Month 9	1.3 (0.2)
CDC category A: Month 12	1.5 (0.4)
CDC category A: Month 15	1.5 (0.3)
CDC category A: Month 18	1.6 (0.6)
CDC category A: Month 21	1.5 (0.3)
CDC category A: Month 24	1.3 (0.0)
CDC category A: Month 27	1.3 (0.0)
CDC category A: Month 33	1.3 (0.0)
CDC category A: Month 36	1.3 (0.0)
CDC category A: Month 39	1.3 (0.0)
CDC category A: Month 42	1.3 (0.0)
CDC category A: Month 45	1.3 (0.0)
CDC category A: Month 48	1.3 (0.0)
CDC category A: Month 51	1.3 (0.0)
CDC category A: Month 57	1.3 (NA)
CDC category A: Month 63	1.3 (NA)
CDC category A: Month 69	1.3 (NA)
CDC category A: Month 75	1.3 (NA)
CDC category A: Month 78	1.3 (NA)
CDC category A: Month 84	1.3 (NA)
CDC category B: Month 0 (Baseline)	1.6 (0.0)
CDC category B: Month 3	1.3 (NA)
CDC category B: Month 6	1.5 (NA)
CDC category B: Month 15	2.1 (1.2)
CDC category B: Month 18	1.5 (0.3)
CDC category B: Month 24	1.3 (NA)
CDC category B: Month 27	1.3 (NA)
CDC category B: Month 30	1.3 (NA)
CDC category B: Month 33	1.3 (NA)
CDC category B: Month 39	1.3 (NA)
CDC category B: Month 42	1.3 (NA)
CDC category B: Month 45	1.3 (NA)
CDC category B: Month 48	1.3 (0.0)
CDC category B: Month 51	1.3 (NA)
CDC category B: Month 60	1.3 (NA)
CDC category B: Month 63	1.3 (NA)
CDC category C: Month 0 (Baseline)	3.0 (1.8)
CDC category C: Month 3	2.3 (1.5)
CDC category C: Month 6	1.9 (0.9)
CDC category C: Month 9	1.6 (0.4)
CDC category C: Month 12	2.3 (1.0)
CDC category C: Month 15	1.7 (0.4)
CDC category C: Month 18	2.0 (0.8)
CDC category C: Month 21	2.1 (0.7)
CDC category C: Month 24	1.6 (0.4)
CDC category C: Month 27	1.8 (0.4)
CDC category C: Month 30	1.9 (0.2)
CDC category C: Month 33	1.4 (0.2)
CDC category C: Month 36	1.5 (0.3)
CDC category C: Month 39	1.6 (0.4)
CDC category C: Month 42	1.9 (0.3)
CDC category C: Month 51	1.5 (NA)
CDC category C: Month 54	1.3 (0.0)
CDC category C: Month 57	1.3 (NA)
CDC category C: Month 60	1.3 (NA)
CDC category C: Month 69	1.3 (NA)

29. Secondary Outcome

Title	Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
CDC category A: Month 0 (Baseline)	347.0 (222.5)
CDC category A: Month 3	416.2 (221.9)
CDC category A: Month 6	428.3 (175.6)
CDC category A: Month 9	457.4 (147.2)
CDC category A: Month 12	524.8 (209.5)
CDC category A: Month 15	441.2 (183.8)
CDC category A: Month 18	401.3 (221.3)
CDC category A: Month 21	777.5 (125.2)
CDC category A: Month 24	567.5 (307.6)
CDC category A: Month 27	784.8 (232.9)
CDC category Month 33	531.7 (214.6)
CDC category A: Month 36	616.5 (195.9)
CDC category A: Month 39	719.3 (126.1)
CDC category A: Month 42	617.0 (245.4)
CDC category A: Month 45	621.3 (183.4)
CDC category A: Month 48	596.0 (9.9)
CDC category A: Month 51	609.0 (287.1)
CDC category A: Month 57	519.0 (NA)
CDC category A: Month 63	712.0 (NA)
CDC category A: Month 69	583.0 (NA)
CDC category A: Month 75	969.0 (NA)
CDC category A: Month 78	787.0 (NA)
CDC category A : Month 84	934.0 (NA)
CDC category B: Month 0 (Baseline)	264.3 (221.4)
CDC category B: Month 3	227.0 (NA)
CDC category B: Month 6	122.0 (NA)
CDC category B: Month 15	447.5 (337.3)
CDC category B: Month 18	371.0 (319.6)
CDC category B: Month 24	207.0 (NA)
CDC category B: Month 27	180.0 (NA)
CDC category B: Month 30	218.0 (NA)
CDC category B: Month 33	137.0 (NA)
CDC category B: Month 39	201.0 (NA)
CDC category B: Month 42	1221.0 (NA)
CDC category B: Month 45	1427.0 (NA)
CDC category B: Month 48	610.0 (637.8)
CDC category B: Month 51	219.0 (NA)
CDC category B: Month 60	149.0 (NA)
CDC category B: Month 63	178.0 (NA)
CDC category C: Month 0 (Baseline)	255.9 (268.5)
CDC category C: Month 3	165.0 (129.4)
CDC category C: Month 6	207.0 (166.7)
CDC category C: Month 9	315.3 (264.1)
CDC category C: Month 12	243.2 (155.8)
CDC category C: Month 15	389.2 (354.3)
CDC category C: Month 18	396.1 (276.3)
CDC category C: Month 21	308.4 (221.7)
CDC category C: Month 24	412.3 (313.9)
CDC category C: Month 27	411.7 (224.0)
CDC category C: Month 30	455.0 (120.2)
CDC category C: Month 33	398.8 (265.6)
CDC category C: Month 36	384.5 (3.5)
CDC category C: Month 39	519.1 (259.3)
CDC category C: Month 42	848.8 (360.3)
CDC category C: Month 51	1111.2 (NA)
CDC category C: Month 54	219.0 (42.4)
CDC category C: Month 57	2070.0 (NA)
CDC category C: Month 60	1155.0 (NA)
CDC category C: Month 69	1429.0 (NA)

30. Secondary Outcome

Title	Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Present: Month 0 (Baseline)	2.4 (1.3)
Present: Month 3	1.6 (0.4)
Present: Month 6	1.7 (0.7)
Present: Month 9	1.4 (0.3)
Present: Month 12	1.8 (0.5)
Present: Month 15	1.6 (0.5)
Present: Month 18	1.8 (0.7)
Present: Month 21	2.1 (0.5)
Present: Month 24	1.5 (0.4)
Present: Month 27	1.4 (0.3)
Present: Month 30	1.7 (0.4)
Present: Month 33	1.3 (0.2)
Present: Month 36	1.4 (0.3)
Present: Month 39	1.4 (0.3)
Present: Month 42	1.5 (0.4)
Present: Month 45	1.3 (0.0)
Present: Month 48	1.3 (0.0)
Present: Month 51	1.3 (0.1)
Present: Month 54	1.3 (0.0)
Present: Month 57	1.3 (0.0)
Present: Month 60	1.3 (0.0)
Present: Month 63	1.3 (0.0)
Present: Month 69	1.3 (0.0)
Present: Month 75	1.3 (NA)
Present: Month 78	1.3 (NA)
Present: Month 84	1.3 (NA)
Absent: Month 0 (Baseline)	4.7 (1.4)
Absent: Month 3	2.2 (1.5)
Absent: Month 6	1.6 (0.5)
Absent: Month 9	1.6 (0.3)
Absent: Month 12	2.0 (1.1)
Absent: Month 15	1.7 (0.6)
Absent: Month 21	1.3 (0.0)
Absent: Month 24	1.3 (NA)
Absent: Month 27	1.3 (NA)
Absent: Month 33	1.3 (NA)
Absent: Month 36	1.3 (NA)
Absent: Month 39	1.3 (NA)
Absent: Month 42	1.3 (NA)

31. Secondary Outcome

Title	Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Present: Month 0	334.8 (266.2)
Present: Month 3	263.0 (203.8)
Present: Month 6	297.6 (214.5)
Present: Month 9	393.7 (216.8)
Present: Month 12	373.2 (176.2)
Present: Month 15	443.2 (240.1)
Present: Month 18	393.3 (244.8)
Present: Month 21	520.6 (253.8)
Present: Month 24	496.2 (236.5)
Present: Month 27	607.1 (327.0)
Present: Month 30	376.0 (161.1)
Present: Month 33	412.1 (224.3)
Present: Month 36	540.0 (191.7)
Present: Month 39	599.9 (234.2)
Present: Month 42	804.7 (363.9)
Present: Month 45	822.8 (429.8)
Present: Month 48	603.0 (368.4)
Present: Month 51	637.1 (401.5)
Present: Month 54	219.0 (42.4)
Present: Month 57	1294.5 (1096.7)
Present: Month 60	652.0 (711.3)
Present: Month 63	445.0 (377.6)
Present: Month 69	1006.0 (598.2)
Present: Month 75	969.0 (NA)
Present: Month 78	787.0 (NA)
Present: Month 84	934.0 (NA)
Absent: Month 0	225.6 (153.5)
Absent: Month 3	382.2 (237.0)
Absent: Month 6	371.0 (175.1)
Absent: Month 9	426.8 (187.7)
Absent: Month 12	394.8 (293.9)
Absent: Month 15	306.5 (430.6)
Absent: Month 21	353.0 (475.2)
Absent: Month 24	14.0 (NA)
Absent: Month 27	660.0 (NA)
Absent: Month 33	801.0 (NA)
Absent: Month 36	382.0 (NA)
Absent: Month 39	236.0 (NA)
Absent: Month 42	746.0 (NA)

32. Secondary Outcome

Title	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
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Present: Month 0 (Baseline)	3.6 (2.4)
Present: Month 3	2.4 (2.1)
Present: Month 6	1.5 (0.3)
Present: Month 9	1.3 (0.0)
Present: Month 12	3.9 (NA)
Present: Month 15	1.6 (0.4)
Present: Month 18	1.3 (NA)
Present: Month 21	1.3 (NA)
Present: Month 24	1.3 (0.0)
Present: Month 33	1.3 (0.0)
Present: Month 36	1.3 (NA)
Present: Month 39	1.3 (NA)
Present: Month 42	1.3 (NA)
Present: Month 45	1.3 (0.0)
Present: Month 48	1.3 (NA)
Present: Month 51	1.3 (0.0)
Present: Month 57	1.3 (NA)
Present: Month 63	1.3 (NA)
Present: Month 69	1.3 (NA)
Present: Month 75	1.3 (NA)
Present: Month 78	1.3 (NA)
Present: Month 84	1.3 (NA)
Absent: Month 0 (Baseline)	3.0 (1.6)
Absent: Month 3	1.7 (0.4)
Absent: Month 6	1.7 (0.7)
Absent: Month 9	1.5 (0.3)
Absent: Month 12	1.7 (0.5)
Absent: Month 15	1.6 (0.6)
Absent: Month 18	1.9 (0.7)
Absent: Month 21	2.0 (0.6)
Absent: Month 24	1.6 (0.4)
Absent: Month 27	1.4 (0.3)
Absent: Month 30	1.7 (0.4)
Absent: Month 33	1.3 (0.2)
Absent: Month 36	1.4 (0.3)
Absent: Month 39	1.4 (0.3)
Absent: Month 42	1.5 (0.4)
Absent: Month 45	1.3 (0.0)
Absent: Month 48	1.3 (0.0)
Absent: Month 51	1.4 (0.2)
Absent: Month 54	1.3 (0.0)
Absent: Month 57	1.3 (NA)
Absent: Month 60	1.3 (0.0)
Absent: Month 63	1.3 (NA)
Absent: Month 69	1.3 (NA)

33. Secondary Outcome

Title	Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri
Description	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.
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	63
Present: Month 0 (Baseline)	200.7 (220.4)
Present: Month 3	193.0 (217.3)
Present: Month 6	212.0 (233.8)
Present: Month 9	223.0 (183.0)
Present: Month 12	4.0 (NA)
Present: Month 15	231.3 (247.2)
Present: Month 18	248.0 (NA)
Present: Month 21	17.0 (NA)
Present: Month 24	182.0 (237.6)
Present: Month 33	367.7 (29.0)
Present: Month 36	478.0 (NA)
Present: Month 39	581.0 (NA)
Present: Month 42	334.0 (NA)
Present: Month 45	526.5 (115.3)
Present: Month 48	589.0 (NA)
Present: Month 51	609.0 (287.1)
Present: Month 57	519.0 (NA)
Present: Month 63	712.0 (NA)
Present: Month 69	583.0 (NA)
Present: Month 75	969.0 (NA)
Present: Month 78	787.0 (NA)
Present: Month 84	934.0 (NA)
Absent: Month 0 (Baseline)	320.0 (243.6)
Absent: Month 3	342.1 (215.8)
Absent: Month 6	342.1 (195.4)
Absent: Month 9	474.3 (163.0)
Absent: Month 12	426.2 (197.0)
Absent: Month 15	507.0 (223.5)
Absent: Month 18	406.5 (252.2)
Absent: Month 21	554.3 (232.4)
Absent: Month 24	525.4 (252.0)
Absent: Month 27	612.4 (308.7)
Absent: Month 30	376.0 (161.1)
Absent: Month 33	477.4 (283.5)
Absent: Month 36	508.0 (213.9)
Absent: Month 39	550.6 (272.1)
Absent: Month 42	887.1 (263.5)
Absent: Month 45	1119.0 (435.6)
Absent: Month 48	607.7 (451.0)
Absent: Month 51	665.1 (630.9)
Absent: Month 54	219.0 (42.4)
Absent: Month 57	2070.0 (NA)
Absent: Month 60	652.0 (711.3)
Absent: Month 63	178.0 (NA)
Absent: Month 69	1429.0 (NA)

34. Secondary Outcome

Title	Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants
Description	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.
Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	32
Count of Participants [Participants]	0 0%

35. Secondary Outcome

Title	Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri
Time Frame	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
Measure Participants	40
At baseline	3.1 (1.7)
At Month 3	1.8 (1.0)
At Month 6	1.6 (0.6)
At Month 9	1.4 (0.3)
At Month 12	1.9 (0.8)
At Month 15	1.6 (0.5)
At Month 18	1.8 (0.7)
At Month 21	1.9 (0.6)
At Month 24	1.5 (0.4)
At Month 27	1.4 (0.3)
At Month 30	1.7 (0.4)
At Month 33	1.3 (0.1)
At Month 36	1.4 (0.2)
At Month 39	1.4 (0.3)
At Month 42	1.5 (0.3)
At Month 45	1.3 (0.0)
At Month 48	1.3 (0.0)
At Month 51	1.3 (0.1)
At Month 54	1.3 (0.0)
At Month 57	1.3 (0.0)
At Month 60	1.3 (0.0)
At Month 63	1.3 (0.0)
At Month 69	1.3 (0.0)
At Month 75	1.3 (NA)
At Month 78	1.3 (NA)
At Month 84	1.3 (NA)

Adverse Events

Time Frame	From April 2009 to December 2018 (up to approximately 8 years 8 months)
Adverse Event Reporting Description	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.
Arm/Group Title	Celsentri (Maraviroc) Tablets
Arm/Group Description	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.
All Cause Mortality
	Celsentri (Maraviroc) Tablets
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Serious Adverse Events
	Celsentri (Maraviroc) Tablets
	Affected / at Risk (%)	# Events
Total	17/68 (25%)
Eye disorders
Glaucoma	1/68 (1.5%)
Necrotising retinitis	1/68 (1.5%)
Vitreous haemorrhage	1/68 (1.5%)
Gastrointestinal disorders
Intra-abdominal haemorrhage	1/68 (1.5%)
Oesophageal varices haemorrhage	1/68 (1.5%)
Upper gastrointestinal haemorrhage	1/68 (1.5%)
Immune system disorders
Immune reconstitution inflammatory syndrome	1/68 (1.5%)
Infections and infestations
Aspergillus infection	1/68 (1.5%)
Cellulitis	1/68 (1.5%)
Helicobacter infection	1/68 (1.5%)
Pneumocystis jirovecii pneumonia	1/68 (1.5%)
Progressive multifocal leukoencephalopathy	1/68 (1.5%)
Syphilis	2/68 (2.9%)
Urinary tract infection	1/68 (1.5%)
Injury, poisoning and procedural complications
Fracture	1/68 (1.5%)
Heat illness	1/68 (1.5%)
Spinal compression fracture	1/68 (1.5%)
Subdural haematoma	1/68 (1.5%)
Metabolism and nutrition disorders
Dehydration	1/68 (1.5%)
Diabetes mellitus	1/68 (1.5%)
Hyperkalaemia	1/68 (1.5%)
Musculoskeletal and connective tissue disorders
Haemarthrosis	1/68 (1.5%)
Lumbar spinal stenosis	1/68 (1.5%)
Nervous system disorders
Cerebral haemorrhage	1/68 (1.5%)
Cerebral infarction	1/68 (1.5%)
Psychiatric disorders
Depressive symptom	1/68 (1.5%)
Psychiatric symptom	1/68 (1.5%)
Renal and urinary disorders
Calculus urinary	1/68 (1.5%)
Prerenal failure	1/68 (1.5%)
Renal impairment	2/68 (2.9%)
Renal tubular disorder	1/68 (1.5%)
Other (Not Including Serious) Adverse Events
	Celsentri (Maraviroc) Tablets
	Affected / at Risk (%)	# Events
Total	20/68 (29.4%)
Blood and lymphatic system disorders
Anaemia	1/68 (1.5%)
Gastrointestinal disorders
Diarrhoea	1/68 (1.5%)
Dry mouth	1/68 (1.5%)
Faeces soft	1/68 (1.5%)
Gastrooesophageal reflux disease	1/68 (1.5%)
Nausea	1/68 (1.5%)
General disorders
Malaise	1/68 (1.5%)
Hepatobiliary disorders
Hepatic function abnormal	1/68 (1.5%)
Hepatic steatosis	1/68 (1.5%)
Liver disorder	1/68 (1.5%)
Infections and infestations
Dermatophytosis of nail	2/68 (2.9%)
Gastroenteritis	1/68 (1.5%)
Herpes zoster	1/68 (1.5%)
Nasopharyngitis	1/68 (1.5%)
Oral candidiasis	2/68 (2.9%)
Investigations
White blood cell count increased	1/68 (1.5%)
Metabolism and nutrition disorders
Dyslipidaemia	2/68 (2.9%)
Hyperlipidaemia	1/68 (1.5%)
Hyperphosphatasaemia	1/68 (1.5%)
Hypertriglyceridaemia	4/68 (5.9%)
Hyperuricaemia	2/68 (2.9%)
Hyponatraemia	1/68 (1.5%)
Obesity	1/68 (1.5%)
Musculoskeletal and connective tissue disorders
Osteopenia	1/68 (1.5%)
Plantar fasciitis	1/68 (1.5%)
Spinal osteoarthritis	1/68 (1.5%)
Nervous system disorders
Cerebral arteriosclerosis	1/68 (1.5%)
Dizziness	1/68 (1.5%)
Headache	1/68 (1.5%)
Skin and subcutaneous tissue disorders
Drug eruption	1/68 (1.5%)
Pruritus	1/68 (1.5%)
Vascular disorders
Hypertension	3/68 (4.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.