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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00864474
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition CCR5-tropic HIV-1 Infection
Intervention Drug: CELSENTRI® Tablets
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celsentri (Maraviroc) Tablets
Hide 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
Arm/Group Title Celsentri (Maraviroc) Tablets
Hide 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 Number of Baseline Participants 68
Hide Baseline Analysis Population Description
All participants those who were registered in this study from April 1, 2009 to March 31, 2017.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants
42.31  (12.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
3
   4.4%
Male
65
  95.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Japanese
67
  98.5%
Others
1
   1.5%
1.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
23.53
2.Primary Outcome
Title Number of Participants With Unknown Adverse Drug Reactions (ADRs)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
8
  11.8%
3.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Males Number Analyzed 65 participants
23.08
Females Number Analyzed 3 participants
33.33
4.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
>=15 and less than(<) 65 years Number Analyzed 63 participants
22.22
>=65 and less than or equal to (<=) 70 years Number Analyzed 5 participants
40.00
5.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Inpatient Number Analyzed 2 participants
0.00
Outpatient Number Analyzed 45 participants
15.56
Inpatient and outpatient Number Analyzed 21 participants
42.86
6.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Japanese Number Analyzed 67 participants
23.88
Others Number Analyzed 1 participants
0.00
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
History of Therapies for HIV Infection: Absent Number Analyzed 16 participants
18.75
History of Therapies for HIV Infection: Present Number Analyzed 52 participants
25.00
8.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
<=1 year Number Analyzed 1 participants
0.00
greater than (>) 4 and <=5 years Number Analyzed 1 participants
0.00
>5 years Number Analyzed 4 participants
50.00
Unknown Number Analyzed 62 participants
22.58
9.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Allergies: Absent Number Analyzed 54 participants
18.52
Allergies: Present Number Analyzed 13 participants
38.46
Allergies: Unknown Number Analyzed 1 participants
100.00
10.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Comorbidities: Absent Number Analyzed 13 participants
15.38
Comorbidities: Present Number Analyzed 55 participants
25.45
11.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Renal Impairment: Absent Number Analyzed 62 participants
20.97
Renal Impairment: Present Number Analyzed 6 participants
50.00
12.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Hepatic Impairment: Absent Number Analyzed 46 participants
21.74
Hepatic Impairment: Present Number Analyzed 22 participants
27.27
13.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Hemophilia: Absent Number Analyzed 61 participants
22.95
Hemophilia: Present Number Analyzed 7 participants
28.57
14.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
<2 tablets Number Analyzed 4 participants
0
2 tablets Number Analyzed 36 participants
16.67
>2 tablets Number Analyzed 28 participants
35.71
15.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
1 drug Number Analyzed 5 participants
0.00
2 drugs Number Analyzed 17 participants
23.53
3 drugs Number Analyzed 28 participants
25.00
>=4 drugs Number Analyzed 18 participants
27.78
16.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
CDC category A Number Analyzed 29 participants
20.69
CDC category B Number Analyzed 5 participants
20.00
CDC category C Number Analyzed 31 participants
29.03
Unknown Number Analyzed 3 participants
0.00
17.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
Concomitant Therapies: Absent Number Analyzed 55 participants
20.00
Concomitant Therapies: Present Number Analyzed 13 participants
38.46
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
CYP3A Enzyme Inducer Use: Absent Number Analyzed 55 participants
21.82
CYP3A Enzyme Inducer Use: Present Number Analyzed 13 participants
30.77
19.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
2 to <=180 days Number Analyzed 68 participants
8.82
> 180 and <=365 days Number Analyzed 60 participants
1.67
> 365 and <=730 days Number Analyzed 52 participants
7.69
> 730 and <= 2704 days Number Analyzed 35 participants
8.57
20.Primary Outcome
Title Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: percentage of participants
4 to <=360 tablets Number Analyzed 68 participants
7.35
> 360 and <=730 tablets Number Analyzed 61 participants
3.28
> 730 and <=1460 tablets Number Analyzed 53 participants
0.00
> 1460 and <=21632 tablets Number Analyzed 41 participants
17.07
21.Primary Outcome
Title Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: ADRs
0
22.Primary Outcome
Title Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: ADRs
3
23.Primary Outcome
Title Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 68
Measure Type: Number
Unit of Measure: ADRs
0
24.Secondary Outcome
Title Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/milliliter(mL)
Males: Month 0 (Baseline) Number Analyzed 39 participants
3.1  (1.7)
Males: Month 3 Number Analyzed 22 participants
1.9  (1.0)
Males: Month 6 Number Analyzed 17 participants
1.6  (0.6)
Males: Month 9 Number Analyzed 11 participants
1.4  (0.3)
Males: Month 12 Number Analyzed 10 participants
1.9  (0.8)
Males: Month 15 Number Analyzed 12 participants
1.7  (0.5)
Males: Month 18 Number Analyzed 12 participants
1.8  (0.7)
Males: Month 21 Number Analyzed 6 participants
1.9  (0.6)
Males: Month 24 Number Analyzed 7 participants
1.5  (0.4)
Males: Month 27 Number Analyzed 10 participants
1.4  (0.3)
Males: Month 30 Number Analyzed 3 participants
1.7  (0.4)
Males: Month 33 Number Analyzed 11 participants
1.3  (0.1)
Males: Month 36 Number Analyzed 4 participants
1.4  (0.2)
Males: Month 39 Number Analyzed 8 participants
1.4  (0.3)
Males: Month 42 Number Analyzed 6 participants
1.5  (0.3)
Males: Month 45 Number Analyzed 4 participants
1.3  (0.0)
Males: Month 48 Number Analyzed 4 participants
1.3  (0.0)
Males: Month 51 Number Analyzed 4 participants
1.3  (0.1)
Males: Month 54 Number Analyzed 2 participants
219.0  (42.4)
Males: Month 57 Number Analyzed 2 participants
1294.5  (1096.7)
Males: Month 60 Number Analyzed 2 participants
1.3  (0.0)
Males: Month 63 Number Analyzed 2 participants
1.3  (0.0)
Males: Month 66 Number Analyzed 0 participants
Males: Month 69 Number Analyzed 2 participants
1.3  (0.0)
Males: Month 72 Number Analyzed 0 participants
Males: Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
Males: Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
Males: Month 81 Number Analyzed 0 participants
Males: Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
Females: Month 0 (Baseline) Number Analyzed 1 participants
1.3 [1]   (NA)
Females: Month 3 Number Analyzed 1 participants
1.3 [1]   (NA)
Females: Month 6 Number Analyzed 0 participants
Females: Month 9 Number Analyzed 0 participants
Females: Month 12 Number Analyzed 0 participants
Females: Month 15 Number Analyzed 1 participants
1.3 [1]   (NA)
Females: Month 18 Number Analyzed 0 participants
Females: Month 21 Number Analyzed 0 participants
Females: Month 24 Number Analyzed 0 participants
Females: Month 27 Number Analyzed 0 participants
Females: Month 30 Number Analyzed 0 participants
Females: Month 33 Number Analyzed 0 participants
Females: Month 36 Number Analyzed 0 participants
Females: Month 39 Number Analyzed 0 participants
Females: Month 42 Number Analyzed 0 participants
Females: Month 45 Number Analyzed 0 participants
Females: Month 48 Number Analyzed 0 participants
Females: Month 51 Number Analyzed 0 participants
Females: Month 54 Number Analyzed 0 participants
Females: Month 57 Number Analyzed 0 participants
Females: Month 60 Number Analyzed 0 participants
Females: Month 63 Number Analyzed 0 participants
Females: Month 66 Number Analyzed 0 participants
Females: Month 69 Number Analyzed 0 participants
Females: Month 72 Number Analyzed 0 participants
Females: Month 75 Number Analyzed 0 participants
Females: Month 78 Number Analyzed 0 participants
Females: Month 81 Number Analyzed 0 participants
Females: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
25.Secondary Outcome
Title Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: CD4 cells/mm^3
Males: Month 0 (Baseline) Number Analyzed 39 participants
301.2  (244.5)
Males: Month 3 Number Analyzed 22 participants
318.2  (221.5)
Males: Month 6 Number Analyzed 17 participants
319.2  (201.2)
Males: Month 9 Number Analyzed 11 participants
405.7  (197.6)
Males: Month 12 Number Analyzed 10 participants
384.0  (228.7)
Males: Month 15 Number Analyzed 12 participants
440.9  (259.2)
Males: Month 18 Number Analyzed 12 participants
393.3  (244.8)
Males: Month 21 Number Analyzed 6 participants
464.7  (302.2)
Males: Month 24 Number Analyzed 7 participants
427.3  (282.6)
Males: Month 27 Number Analyzed 10 participants
612.4  (308.7)
Males: Month 30 Number Analyzed 3 participants
376.0  (161.1)
Males: Month 33 Number Analyzed 11 participants
447.5  (243.0)
Males: Month 36 Number Analyzed 4 participants
500.5  (175.3)
Males: Month 39 Number Analyzed 8 participants
554.4  (252.1)
Males: Month 42 Number Analyzed 6 participants
794.9  (326.4)
Males: Month 45 Number Analyzed 4 participants
822.8  (429.8)
Males: Month 48 Number Analyzed 4 participants
603.0  (368.4)
Males: Month 51 Number Analyzed 4 participants
637.1  (401.5)
Males: Month 54 Number Analyzed 2 participants
219.0  (42.4)
Males: Month 57 Number Analyzed 2 participants
1294.5  (1096.7)
Males: Month 60 Number Analyzed 2 participants
652.0  (711.3)
Males: Month 63 Number Analyzed 2 participants
445.0  (377.6)
Males: Month 66 Number Analyzed 0 participants
Males: Month 69 Number Analyzed 2 participants
1006.0  (598.2)
Males: Month 72 Number Analyzed 0 participants
Males: Month 75 Number Analyzed 1 participants
969.0 [1]   (NA)
Males: Month 78 Number Analyzed 1 participants
787.0 [1]   (NA)
Males: Month 81 Number Analyzed 0 participants
Males: Month 84 Number Analyzed 1 participants
934.0 [1]   (NA)
Females: Month 0 (Baseline) Number Analyzed 1 participants
335.0 [1]   (NA)
Females: Month 3 Number Analyzed 1 participants
122.0 [1]   (NA)
Females: Month 6 Number Analyzed 0 participants
Females: Month 9 Number Analyzed 0 participants
Females: Month 12 Number Analyzed 0 participants
Females: Month 15 Number Analyzed 1 participants
197.0 [1]   (NA)
Females: Month 18 Number Analyzed 0 participants
Females: Month 21 Number Analyzed 0 participants
Females: Month 24 Number Analyzed 0 participants
Females: Month 27 Number Analyzed 0 participants
Females: Month 30 Number Analyzed 0 participants
Females: Month 33 Number Analyzed 0 participants
Females: Month 36 Number Analyzed 0 participants
Females: Month 39 Number Analyzed 0 participants
Females: Month 42 Number Analyzed 0 participants
Females: Month 45 Number Analyzed 0 participants
Females: Month 48 Number Analyzed 0 participants
Females: Month 51 Number Analyzed 0 participants
Females: Month 54 Number Analyzed 0 participants
Females: Month 57 Number Analyzed 0 participants
Females: Month 60 Number Analyzed 0 participants
Females: Month 63 Number Analyzed 0 participants
Females: Month 66 Number Analyzed 0 participants
Females: Month 69 Number Analyzed 0 participants
Females: Month 72 Number Analyzed 0 participants
Females: Month 75 Number Analyzed 0 participants
Females: Month 78 Number Analyzed 0 participants
Females: Month 81 Number Analyzed 0 participants
Females: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/mL
Comorbidities-Present: Month 0 (Baseline) Number Analyzed 30 participants
2.8  (1.7)
Comorbidities-Present: Month 3 Number Analyzed 17 participants
1.9  (1.1)
Comorbidities-Present: Month 6 Number Analyzed 12 participants
1.8  (0.7)
Comorbidities-Present: Month 9 Number Analyzed 8 participants
1.5  (0.3)
Comorbidities-Present: Month 12 Number Analyzed 8 participants
2.1  (0.9)
Comorbidities-Present: Month 15 Number Analyzed 10 participants
1.6  (0.6)
Comorbidities-Present: Month 18 Number Analyzed 11 participants
1.8  (0.7)
Comorbidities-Present: Month 21 Number Analyzed 4 participants
2.1  (0.7)
Comorbidities-Present: Month 24 Number Analyzed 7 participants
1.5  (0.4)
Comorbidities-Present: Month 27 Number Analyzed 6 participants
1.5  (0.4)
Comorbidities-Present: Month 30 Number Analyzed 3 participants
1.7  (0.4)
Comorbidities-Present: Month 33 Number Analyzed 7 participants
1.3  (0.2)
Comorbidities-Present: Month 36 Number Analyzed 3 participants
1.4  (0.3)
Comorbidities-Present: Month 39 Number Analyzed 6 participants
1.5  (0.4)
Comorbidities-Present: Month 42 Number Analyzed 4 participants
1.6  (0.4)
Comorbidities-Present: Month 45 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Present: Month 48 Number Analyzed 3 participants
1.3  (0.0)
Comorbidities-Present: Month 51 Number Analyzed 3 participants
1.4  (0.1)
Comorbidities-Present: Month 54 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Present: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Present: Month 60 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Present: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Present: Month 66 Number Analyzed 0 participants
Comorbidities-Present: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Present: Month 72 Number Analyzed 0 participants
Comorbidities-Present: Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Present: Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Present: Month 81 Number Analyzed 0 participants
Comorbidities-Present: Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 0 (Baseline) Number Analyzed 10 participants
3.8  (1.6)
Comorbidities-Absent: Month 3 Number Analyzed 6 participants
1.8  (0.3)
Comorbidities-Absent: Month 6 Number Analyzed 5 participants
1.4  (0.2)
Comorbidities-Absent: Month 9 Number Analyzed 3 participants
1.3  (0.0)
Comorbidities-Absent: Month 12 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Absent: Month 15 Number Analyzed 3 participants
1.7  (0.4)
Comorbidities-Absent: Month 18 Number Analyzed 1 participants
2.4 [1]   (NA)
Comorbidities-Absent: Month 21 Number Analyzed 2 participants
1.5  (0.3)
Comorbidities-Absent: Month 24 Number Analyzed 0 participants
Comorbidities-Absent: Month 27 Number Analyzed 4 participants
1.3  (0.0)
Comorbidities-Absent: Month 30 Number Analyzed 0 participants
Comorbidities-Absent: Month 33 Number Analyzed 4 participants
1.3  (0.0)
Comorbidities-Absent: Month 36 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 39 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Absent: Month 42 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Absent: Month 45 Number Analyzed 2 participants
1.3  (0.0)
Comorbidities-Absent: Month 48 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 51 Number Analyzed 1 participants
1.3 [2]   (NA)
Comorbidities-Absent: Month 54 Number Analyzed 0 participants
Comorbidities-Absent: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 60 Number Analyzed 0 participants
Comorbidities-Absent: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 66 Number Analyzed 0 participants
Comorbidities-Absent: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
Comorbidities-Absent: Month 72 Number Analyzed 0 participants
Comorbidities-Absent: Month 75 Number Analyzed 0 participants
Comorbidities-Absent: Month 78 Number Analyzed 0 participants
Comorbidities-Absent: Month 81 Number Analyzed 0 participants
Comorbidities-Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
[2]
Standard Deviation cannot be calculated as CD4 cell count is available for 1 participant only.
27.Secondary Outcome
Title Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: CD4 cells/mm^3
Comorbidities-Present: Month 0 (Baseline) Number Analyzed 30 participants
294.2  (249.5)
Comorbidities-Present: Month 3 Number Analyzed 17 participants
282.0  (205.0)
Comorbidities-Present: Month 6 Number Analyzed 12 participants
284.9  (196.2)
Comorbidities-Present: Month 9 Number Analyzed 8 participants
361.5  (199.0)
Comorbidities-Present: Month 12 Number Analyzed 8 participants
303.3  (170.9)
Comorbidities-Present: Month 15 Number Analyzed 10 participants
422.9  (286.3)
Comorbidities-Present: Month 18 Number Analyzed 11 participants
401.6  (254.9)
Comorbidities-Present: Month 21 Number Analyzed 4 participants
308.4  (221.7)
Comorbidities-Present: Month 24 Number Analyzed 7 participants
427.3  (282.6)
Comorbidities-Present: Month 27 Number Analyzed 6 participants
558.7  (399.4)
Comorbidities-Present: Month 30 Number Analyzed 3 participants
376.0  (161.1)
Comorbidities-Present: Month 33 Number Analyzed 7 participants
357.0  (211.6)
Comorbidities-Present: Month 36 Number Analyzed 3 participants
415.7  (54.0)
Comorbidities-Present: Month 39 Number Analyzed 6 participants
476.4  (243.2)
Comorbidities-Present: Month 42 Number Analyzed 4 participants
813.2  (419.6)
Comorbidities-Present: Month 45 Number Analyzed 2 participants
1017.5  (579.1)
Comorbidities-Present: Month 48 Number Analyzed 3 participants
603.0  (451.2)
Comorbidities-Present: Month 51 Number Analyzed 3 participants
714.1  (454.1)
Comorbidities-Present: Month 54 Number Analyzed 2 participants
219.0  (42.4)
Comorbidities-Present: Month 57 Number Analyzed 1 participants
2070.0 [1]   (NA)
Comorbidities-Present: Month 60 Number Analyzed 2 participants
652.0  (711.3)
Comorbidities-Present: Month 63 Number Analyzed 1 participants
178.0 [1]   (NA)
Comorbidities-Present: Month 66 Number Analyzed 0 participants
Comorbidities-Present: Month 69 Number Analyzed 1 participants
1429.0 [1]   (NA)
Comorbidities-Present: Month 72 Number Analyzed 0 participants
Comorbidities-Present: Month 75 Number Analyzed 1 participants
969.0 [1]   (NA)
Comorbidities-Present: Month 78 Number Analyzed 1 participants
787.0 [1]   (NA)
Comorbidities-Present: Month 81 Number Analyzed 0 participants
Comorbidities-Present: Month 84 Number Analyzed 1 participants
934.0 [1]   (NA)
Comorbidities-Absent: Month 0 (Baseline) Number Analyzed 10 participants
325.6  (226.1)
Comorbidities-Absent: Month 3 Number Analyzed 6 participants
388.0  (262.5)
Comorbidities-Absent: Month 6 Number Analyzed 5 participants
401.4  (210.1)
Comorbidities-Absent: Month 9 Number Analyzed 3 participants
523.7  (167.4)
Comorbidities-Absent: Month 12 Number Analyzed 2 participants
707.0  (75.0)
Comorbidities-Absent: Month 15 Number Analyzed 3 participants
419.7  (167.0)
Comorbidities-Absent: Month 18 Number Analyzed 1 participants
301.0 [1]   (NA)
Comorbidities-Absent: Month 21 Number Analyzed 2 participants
777.5  (125.2)
Comorbidities-Absent: Month 24 Number Analyzed 0 participants
Comorbidities-Absent: Month 27 Number Analyzed 4 participants
693.0  (75.5)
Comorbidities-Absent: Month 30 Number Analyzed 0 participants
Comorbidities-Absent: Month 33 Number Analyzed 4 participants
605.8  (234.0)
Comorbidities-Absent: Month 36 Number Analyzed 1 participants
755.0 [1]   (NA)
Comorbidities-Absent: Month 39 Number Analyzed 2 participants
788.5  (55.9)
Comorbidities-Absent: Month 42 Number Analyzed 2 participants
758.5  (17.7)
Comorbidities-Absent: Month 45 Number Analyzed 2 participants
628.0  (258.8)
Comorbidities-Absent: Month 48 Number Analyzed 1 participants
603.0 [1]   (NA)
Comorbidities-Absent: Month 51 Number Analyzed 1 participants
406.0 [1]   (NA)
Comorbidities-Absent: Month 54 Number Analyzed 0 participants
Comorbidities-Absent: Month 57 Number Analyzed 1 participants
519.0 [1]   (NA)
Comorbidities-Absent: Month 60 Number Analyzed 0 participants
Comorbidities-Absent: Month 63 Number Analyzed 1 participants
712.0 [1]   (NA)
Comorbidities-Absent: Month 66 Number Analyzed 0 participants
Comorbidities -Absent: Month 69 Number Analyzed 1 participants
583.0 [1]   (NA)
Comorbidities-Absent: Month 72 Number Analyzed 0 participants
Comorbidities-Absent: Month 75 Number Analyzed 0 participants
Comorbidities-Absent: Month 78 Number Analyzed 0 participants
Comorbidities-Absent: Month 81 Number Analyzed 0 participants
Comorbidities-Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
28.Secondary Outcome
Title Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/mL
CDC category A: Month 0 (Baseline) Number Analyzed 20 participants
3.4  (1.7)
CDC category A: Month 3 Number Analyzed 13 participants
1.6  (0.3)
CDC category A: Month 6 Number Analyzed 9 participants
1.5  (0.3)
CDC category A: Month 9 Number Analyzed 7 participants
1.3  (0.2)
CDC category A: Month 12 Number Analyzed 5 participants
1.5  (0.4)
CDC category A: Month 15 Number Analyzed 6 participants
1.5  (0.3)
CDC category A: Month 18 Number Analyzed 3 participants
1.6  (0.6)
CDC category A: Month 21 Number Analyzed 2 participants
1.5  (0.3)
CDC category A: Month 24 Number Analyzed 2 participants
1.3  (0.0)
CDC category A: Month 27 Number Analyzed 6 participants
1.3  (0.0)
CDC category A: Month 30 Number Analyzed 0 participants
CDC category A: Month 33 Number Analyzed 6 participants
1.3  (0.0)
CDC category A: Month 36 Number Analyzed 2 participants
1.3  (0.0)
CDC category A: Month 39 Number Analyzed 3 participants
1.3  (0.0)
CDC category A: Month 42 Number Analyzed 3 participants
1.3  (0.0)
CDC category A: Month 45 Number Analyzed 3 participants
1.3  (0.0)
CDC category A: Month 48 Number Analyzed 2 participants
1.3  (0.0)
CDC category A: Month 51 Number Analyzed 2 participants
1.3  (0.0)
CDC category A: Month 54 Number Analyzed 0 participants
CDC category A: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category A: Month 60 Number Analyzed 0 participants
CDC category A: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category A: Month 66 Number Analyzed 0 participants
CDC category A: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category A: Month 72 Number Analyzed 0 participants
CDC category A: Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category A: Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category A: Month 81 Number Analyzed 0 participants
CDC category A: Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 0 (Baseline) Number Analyzed 3 participants
1.6  (0.0)
CDC category B: Month 3 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 6 Number Analyzed 1 participants
1.5 [1]   (NA)
CDC category B: Month 9 Number Analyzed 0 participants
CDC category B: Month 12 Number Analyzed 0 participants
CDC category B: Month 15 Number Analyzed 2 participants
2.1  (1.2)
CDC category B: Month 18 Number Analyzed 2 participants
1.5  (0.3)
CDC category B: Month 21 Number Analyzed 0 participants
CDC category B: Month 24 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 27 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 30 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 33 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 36 Number Analyzed 0 participants
CDC category B: Month 39 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 42 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 45 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 48 Number Analyzed 2 participants
1.3  (0.0)
CDC category B: Month 51 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 54 Number Analyzed 0 participants
CDC category B: Month 57 Number Analyzed 0 participants
CDC category B: Month 60 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category B: Month 66 Number Analyzed 0 participants
CDC category B: Month 69 Number Analyzed 0 participants
CDC category B: Month 72 Number Analyzed 0 participants
CDC category B: Month 75 Number Analyzed 0 participants
CDC category B: Month 78 Number Analyzed 0 participants
CDC category B: Month 81 Number Analyzed 0 participants
CDC category B: Month 84 Number Analyzed 0 participants
CDC category C: Month 0 (Baseline) Number Analyzed 17 participants
3.0  (1.8)
CDC category C: Month 3 Number Analyzed 9 participants
2.3  (1.5)
CDC category C: Month 6 Number Analyzed 7 participants
1.9  (0.9)
CDC category C: Month 9 Number Analyzed 4 participants
1.6  (0.4)
CDC category C: Month 12 Number Analyzed 5 participants
2.3  (1.0)
CDC category C: Month 15 Number Analyzed 5 participants
1.7  (0.4)
CDC category C: Month 18 Number Analyzed 7 participants
2.0  (0.8)
CDC category C: Month 21 Number Analyzed 4 participants
2.1  (0.7)
CDC category C: Month 24 Number Analyzed 4 participants
1.6  (0.4)
CDC category C: Month 27 Number Analyzed 3 participants
1.8  (0.4)
CDC category C: Month 30 Number Analyzed 2 participants
1.9  (0.2)
CDC category C: Month 33 Number Analyzed 4 participants
1.4  (0.2)
CDC category C: Month 36 Number Analyzed 2 participants
1.5  (0.3)
CDC category C: Month 39 Number Analyzed 4 participants
1.6  (0.4)
CDC category C: Month 42 Number Analyzed 2 participants
1.9  (0.3)
CDC category C: Month 45 Number Analyzed 0 participants
CDC category C: Month 48 Number Analyzed 0 participants
CDC category C: Month 51 Number Analyzed 1 participants
1.5 [1]   (NA)
CDC category C: Month 54 Number Analyzed 2 participants
1.3  (0.0)
CDC category C: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category C: Month 60 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category C: Month 63 Number Analyzed 0 participants
CDC category C: Month 66 Number Analyzed 0 participants
CDC category C: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
CDC category C: Month 72 Number Analyzed 0 participants
CDC category C: Month 75 Number Analyzed 0 participants
CDC category C: Month 78 Number Analyzed 0 participants
CDC category C: Month 81 Number Analyzed 0 participants
CDC category C: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
29.Secondary Outcome
Title Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: CD4 cells/mm^3
CDC category A: Month 0 (Baseline) Number Analyzed 20 participants
347.0  (222.5)
CDC category A: Month 3 Number Analyzed 13 participants
416.2  (221.9)
CDC category A: Month 6 Number Analyzed 9 participants
428.3  (175.6)
CDC category A: Month 9 Number Analyzed 7 participants
457.4  (147.2)
CDC category A: Month 12 Number Analyzed 5 participants
524.8  (209.5)
CDC category A: Month 15 Number Analyzed 6 participants
441.2  (183.8)
CDC category A: Month 18 Number Analyzed 3 participants
401.3  (221.3)
CDC category A: Month 21 Number Analyzed 2 participants
777.5  (125.2)
CDC category A: Month 24 Number Analyzed 2 participants
567.5  (307.6)
CDC category A: Month 27 Number Analyzed 6 participants
784.8  (232.9)
CDC category A: Month 30 Number Analyzed 0 participants
CDC category Month 33 Number Analyzed 6 participants
531.7  (214.6)
CDC category A: Month 36 Number Analyzed 2 participants
616.5  (195.9)
CDC category A: Month 39 Number Analyzed 3 participants
719.3  (126.1)
CDC category A: Month 42 Number Analyzed 3 participants
617.0  (245.4)
CDC category A: Month 45 Number Analyzed 3 participants
621.3  (183.4)
CDC category A: Month 48 Number Analyzed 2 participants
596.0  (9.9)
CDC category A: Month 51 Number Analyzed 2 participants
609.0  (287.1)
CDC category A: Month 54 Number Analyzed 0 participants
CDC category A: Month 57 Number Analyzed 1 participants
519.0 [1]   (NA)
CDC category A: Month 60 Number Analyzed 0 participants
CDC category A: Month 63 Number Analyzed 1 participants
712.0 [1]   (NA)
CDC category A: Month 66 Number Analyzed 0 participants
CDC category A: Month 69 Number Analyzed 1 participants
583.0 [1]   (NA)
CDC category A: Month 72 Number Analyzed 0 participants
CDC category A: Month 75 Number Analyzed 1 participants
969.0 [1]   (NA)
CDC category A: Month 78 Number Analyzed 1 participants
787.0 [1]   (NA)
CDC category A: Month 81 Number Analyzed 0 participants
CDC category A : Month 84 Number Analyzed 1 participants
934.0 [1]   (NA)
CDC category B: Month 0 (Baseline) Number Analyzed 3 participants
264.3  (221.4)
CDC category B: Month 3 Number Analyzed 1 participants
227.0 [1]   (NA)
CDC category B: Month 6 Number Analyzed 1 participants
122.0 [1]   (NA)
CDC category B: Month 9 Number Analyzed 0 participants
CDC category B: Month 12 Number Analyzed 0 participants
CDC category B: Month 15 Number Analyzed 2 participants
447.5  (337.3)
CDC category B: Month 18 Number Analyzed 2 participants
371.0  (319.6)
CDC category B: Month 21 Number Analyzed 0 participants
CDC category B: Month 24 Number Analyzed 1 participants
207.0 [1]   (NA)
CDC category B: Month 27 Number Analyzed 1 participants
180.0 [1]   (NA)
CDC category B: Month 30 Number Analyzed 1 participants
218.0 [1]   (NA)
CDC category B: Month 33 Number Analyzed 1 participants
137.0 [1]   (NA)
CDC category B: Month 36 Number Analyzed 0 participants
CDC category B: Month 39 Number Analyzed 1 participants
201.0 [1]   (NA)
CDC category B: Month 42 Number Analyzed 1 participants
1221.0 [1]   (NA)
CDC category B: Month 45 Number Analyzed 1 participants
1427.0 [1]   (NA)
CDC category B: Month 48 Number Analyzed 2 participants
610.0  (637.8)
CDC category B: Month 51 Number Analyzed 1 participants
219.0 [1]   (NA)
CDC category B: Month 54 Number Analyzed 0 participants
CDC category B: Month 57 Number Analyzed 0 participants
CDC category B: Month 60 Number Analyzed 1 participants
149.0 [1]   (NA)
CDC category B: Month 63 Number Analyzed 1 participants
178.0 [1]   (NA)
CDC category B: Month 66 Number Analyzed 0 participants
CDC category B: Month 69 Number Analyzed 0 participants
CDC category B: Month 72 Number Analyzed 0 participants
CDC category B: Month 75 Number Analyzed 0 participants
CDC category B: Month 78 Number Analyzed 0 participants
CDC category B: Month 81 Number Analyzed 0 participants
CDC category B: Month 84 Number Analyzed 0 participants
CDC category C: Month 0 (Baseline) Number Analyzed 17 participants
255.9  (268.5)
CDC category C: Month 3 Number Analyzed 9 participants
165.0  (129.4)
CDC category C: Month 6 Number Analyzed 7 participants
207.0  (166.7)
CDC category C: Month 9 Number Analyzed 4 participants
315.3  (264.1)
CDC category C: Month 12 Number Analyzed 5 participants
243.2  (155.8)
CDC category C: Month 15 Number Analyzed 5 participants
389.2  (354.3)
CDC category C: Month 18 Number Analyzed 7 participants
396.1  (276.3)
CDC category C: Month 21 Number Analyzed 4 participants
308.4  (221.7)
CDC category C: Month 24 Number Analyzed 4 participants
412.3  (313.9)
CDC category C: Month 27 Number Analyzed 3 participants
411.7  (224.0)
CDC category C: Month 30 Number Analyzed 2 participants
455.0  (120.2)
CDC category C: Month 33 Number Analyzed 4 participants
398.8  (265.6)
CDC category C: Month 36 Number Analyzed 2 participants
384.5  (3.5)
CDC category C: Month 39 Number Analyzed 4 participants
519.1  (259.3)
CDC category C: Month 42 Number Analyzed 2 participants
848.8  (360.3)
CDC category C: Month 45 Number Analyzed 0 participants
CDC category C: Month 48 Number Analyzed 0 participants
CDC category C: Month 51 Number Analyzed 1 participants
1111.2 [1]   (NA)
CDC category C: Month 54 Number Analyzed 2 participants
219.0  (42.4)
CDC category C: Month 57 Number Analyzed 1 participants
2070.0 [1]   (NA)
CDC category C: Month 60 Number Analyzed 1 participants
1155.0 [1]   (NA)
CDC category C: Month 63 Number Analyzed 0 participants
CDC category C: Month 66 Number Analyzed 0 participants
CDC category C: Month 69 Number Analyzed 1 participants
1429.0 [1]   (NA)
CDC category C: Month 72 Number Analyzed 0 participants
CDC category C: Month 75 Number Analyzed 0 participants
CDC category C: Month 78 Number Analyzed 0 participants
CDC category C: Month 81 Number Analyzed 0 participants
CDC category C: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
30.Secondary Outcome
Title Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/mL
Present: Month 0 (Baseline) Number Analyzed 28 participants
2.4  (1.3)
Present: Month 3 Number Analyzed 14 participants
1.6  (0.4)
Present: Month 6 Number Analyzed 12 participants
1.7  (0.7)
Present: Month 9 Number Analyzed 7 participants
1.4  (0.3)
Present: Month 12 Number Analyzed 5 participants
1.8  (0.5)
Present: Month 15 Number Analyzed 11 participants
1.6  (0.5)
Present: Month 18 Number Analyzed 12 participants
1.8  (0.7)
Present: Month 21 Number Analyzed 4 participants
2.1  (0.5)
Present: Month 24 Number Analyzed 6 participants
1.5  (0.4)
Present: Month 27 Number Analyzed 9 participants
1.4  (0.3)
Present: Month 30 Number Analyzed 3 participants
1.7  (0.4)
Present: Month 33 Number Analyzed 10 participants
1.3  (0.2)
Present: Month 36 Number Analyzed 3 participants
1.4  (0.3)
Present: Month 39 Number Analyzed 7 participants
1.4  (0.3)
Present: Month 42 Number Analyzed 5 participants
1.5  (0.4)
Present: Month 45 Number Analyzed 4 participants
1.3  (0.0)
Present: Month 48 Number Analyzed 4 participants
1.3  (0.0)
Present: Month 51 Number Analyzed 4 participants
1.3  (0.1)
Present: Month 54 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 57 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 60 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 63 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 66 Number Analyzed 0 participants
Present: Month 69 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 72 Number Analyzed 0 participants
Present: Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 81 Number Analyzed 0 participants
Present: Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 0 (Baseline) Number Analyzed 12 participants
4.7  (1.4)
Absent: Month 3 Number Analyzed 9 participants
2.2  (1.5)
Absent: Month 6 Number Analyzed 5 participants
1.6  (0.5)
Absent: Month 9 Number Analyzed 4 participants
1.6  (0.3)
Absent: Month 12 Number Analyzed 5 participants
2.0  (1.1)
Absent: Month 15 Number Analyzed 2 participants
1.7  (0.6)
Absent: Month 18 Number Analyzed 0 participants
Absent: Month 21 Number Analyzed 2 participants
1.3  (0.0)
Absent: Month 24 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 27 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 30 Number Analyzed 0 participants
Absent: Month 33 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 36 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 39 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 42 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 45 Number Analyzed 0 participants
Absent: Month 48 Number Analyzed 0 participants
Absent: Month 51 Number Analyzed 0 participants
Absent: Month 54 Number Analyzed 0 participants
Absent: Month 57 Number Analyzed 0 participants
Absent: Month 60 Number Analyzed 0 participants
Absent: Month 63 Number Analyzed 0 participants
Absent: Month 66 Number Analyzed 0 participants
Absent: Month 69 Number Analyzed 0 participants
Absent: Month 72 Number Analyzed 0 participants
Absent: Month 75 Number Analyzed 0 participants
Absent: Month 78 Number Analyzed 0 participants
Absent: Month 81 Number Analyzed 0 participants
Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
31.Secondary Outcome
Title Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: CD4 cells/mm^3
Present: Month 0 Number Analyzed 28 participants
334.8  (266.2)
Present: Month 3 Number Analyzed 14 participants
263.0  (203.8)
Present: Month 6 Number Analyzed 12 participants
297.6  (214.5)
Present: Month 9 Number Analyzed 7 participants
393.7  (216.8)
Present: Month 12 Number Analyzed 5 participants
373.2  (176.2)
Present: Month 15 Number Analyzed 11 participants
443.2  (240.1)
Present: Month 18 Number Analyzed 12 participants
393.3  (244.8)
Present: Month 21 Number Analyzed 4 participants
520.6  (253.8)
Present: Month 24 Number Analyzed 6 participants
496.2  (236.5)
Present: Month 27 Number Analyzed 9 participants
607.1  (327.0)
Present: Month 30 Number Analyzed 3 participants
376.0  (161.1)
Present: Month 33 Number Analyzed 10 participants
412.1  (224.3)
Present: Month 36 Number Analyzed 3 participants
540.0  (191.7)
Present: Month 39 Number Analyzed 7 participants
599.9  (234.2)
Present: Month 42 Number Analyzed 5 participants
804.7  (363.9)
Present: Month 45 Number Analyzed 4 participants
822.8  (429.8)
Present: Month 48 Number Analyzed 4 participants
603.0  (368.4)
Present: Month 51 Number Analyzed 4 participants
637.1  (401.5)
Present: Month 54 Number Analyzed 2 participants
219.0  (42.4)
Present: Month 57 Number Analyzed 2 participants
1294.5  (1096.7)
Present: Month 60 Number Analyzed 2 participants
652.0  (711.3)
Present: Month 63 Number Analyzed 2 participants
445.0  (377.6)
Present: Month 66 Number Analyzed 0 participants
Present: Month 69 Number Analyzed 2 participants
1006.0  (598.2)
Present: Month 72 Number Analyzed 0 participants
Present: Month 75 Number Analyzed 1 participants
969.0 [1]   (NA)
Present: Month 78 Number Analyzed 1 participants
787.0 [1]   (NA)
Present: Month 81 Number Analyzed 0 participants
Present: Month 84 Number Analyzed 1 participants
934.0 [1]   (NA)
Absent: Month 0 Number Analyzed 12 participants
225.6  (153.5)
Absent: Month 3 Number Analyzed 9 participants
382.2  (237.0)
Absent: Month 6 Number Analyzed 5 participants
371.0  (175.1)
Absent: Month 9 Number Analyzed 4 participants
426.8  (187.7)
Absent: Month 12 Number Analyzed 5 participants
394.8  (293.9)
Absent: Month 15 Number Analyzed 2 participants
306.5  (430.6)
Absent: Month 18 Number Analyzed 0 participants
Absent: Month 21 Number Analyzed 2 participants
353.0  (475.2)
Absent: Month 24 Number Analyzed 1 participants
14.0 [1]   (NA)
Absent: Month 27 Number Analyzed 1 participants
660.0 [1]   (NA)
Absent: Month 30 Number Analyzed 0 participants
Absent: Month 33 Number Analyzed 1 participants
801.0 [1]   (NA)
Absent: Month 36 Number Analyzed 1 participants
382.0 [1]   (NA)
Absent: Month 39 Number Analyzed 1 participants
236.0 [1]   (NA)
Absent: Month 42 Number Analyzed 1 participants
746.0 [1]   (NA)
Absent: Month 45 Number Analyzed 0 participants
Absent: Month 48 Number Analyzed 0 participants
Absent: Month 51 Number Analyzed 0 participants
Absent: Month 54 Number Analyzed 0 participants
Absent: Month 57 Number Analyzed 0 participants
Absent: Month 60 Number Analyzed 0 participants
Absent: Month 63 Number Analyzed 0 participants
Absent: Month 66 Number Analyzed 0 participants
Absent: Month 69 Number Analyzed 0 participants
Absent: Month 72 Number Analyzed 0 participants
Absent: Month 75 Number Analyzed 0 participants
Absent: Month 78 Number Analyzed 0 participants
Absent: Month 81 Number Analyzed 0 participants
Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/mL
Present: Month 0 (Baseline) Number Analyzed 6 participants
3.6  (2.4)
Present: Month 3 Number Analyzed 5 participants
2.4  (2.1)
Present: Month 6 Number Analyzed 3 participants
1.5  (0.3)
Present: Month 9 Number Analyzed 3 participants
1.3  (0.0)
Present: Month 12 Number Analyzed 1 participants
3.9 [1]   (NA)
Present: Month 15 Number Analyzed 4 participants
1.6  (0.4)
Present: Month 18 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 21 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 24 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 27 Number Analyzed 0 participants
Present: Month 30 Number Analyzed 0 participants
Present: Month 33 Number Analyzed 3 participants
1.3  (0.0)
Present: Month 36 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 39 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 42 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 45 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 48 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 51 Number Analyzed 2 participants
1.3  (0.0)
Present: Month 54 Number Analyzed 0 participants
Present: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 60 Number Analyzed 0 participants
Present: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 66 Number Analyzed 0 participants
Present: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 72 Number Analyzed 0 participants
Present: Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
Present: Month 81 Number Analyzed 0 participants
Present: Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 0 (Baseline) Number Analyzed 34 participants
3.0  (1.6)
Absent: Month 3 Number Analyzed 18 participants
1.7  (0.4)
Absent: Month 6 Number Analyzed 14 participants
1.7  (0.7)
Absent: Month 9 Number Analyzed 8 participants
1.5  (0.3)
Absent: Month 12 Number Analyzed 9 participants
1.7  (0.5)
Absent: Month 15 Number Analyzed 9 participants
1.6  (0.6)
Absent: Month 18 Number Analyzed 11 participants
1.9  (0.7)
Absent: Month 21 Number Analyzed 5 participants
2.0  (0.6)
Absent: Month 24 Number Analyzed 5 participants
1.6  (0.4)
Absent: Month 27 Number Analyzed 10 participants
1.4  (0.3)
Absent: Month 30 Number Analyzed 3 participants
1.7  (0.4)
Absent: Month 33 Number Analyzed 8 participants
1.3  (0.2)
Absent: Month 36 Number Analyzed 3 participants
1.4  (0.3)
Absent: Month 39 Number Analyzed 7 participants
1.4  (0.3)
Absent: Month 42 Number Analyzed 5 participants
1.5  (0.4)
Absent: Month 45 Number Analyzed 2 participants
1.3  (0.0)
Absent: Month 48 Number Analyzed 3 participants
1.3  (0.0)
Absent: Month 51 Number Analyzed 2 participants
1.4  (0.2)
Absent: Month 54 Number Analyzed 2 participants
1.3  (0.0)
Absent: Month 57 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 60 Number Analyzed 2 participants
1.3  (0.0)
Absent: Month 63 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 66 Number Analyzed 0 participants
Absent: Month 69 Number Analyzed 1 participants
1.3 [1]   (NA)
Absent: Month 72 Number Analyzed 0 participants
Absent: Month 75 Number Analyzed 0 participants
Absent: Month 78 Number Analyzed 0 participants
Absent: Month 81 Number Analyzed 0 participants
Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 63
Mean (Standard Deviation)
Unit of Measure: CD4 cells/mm^3
Present: Month 0 (Baseline) Number Analyzed 6 participants
200.7  (220.4)
Present: Month 3 Number Analyzed 5 participants
193.0  (217.3)
Present: Month 6 Number Analyzed 3 participants
212.0  (233.8)
Present: Month 9 Number Analyzed 3 participants
223.0  (183.0)
Present: Month 12 Number Analyzed 1 participants
4.0 [1]   (NA)
Present: Month 15 Number Analyzed 4 participants
231.3  (247.2)
Present: Month 18 Number Analyzed 1 participants
248.0 [1]   (NA)
Present: Month 21 Number Analyzed 1 participants
17.0 [1]   (NA)
Present: Month 24 Number Analyzed 2 participants
182.0  (237.6)
Present: Month 27 Number Analyzed 0 participants
Present: Month 30 Number Analyzed 0 participants
Present: Month 33 Number Analyzed 3 participants
367.7  (29.0)
Present: Month 36 Number Analyzed 1 participants
478.0 [1]   (NA)
Present: Month 39 Number Analyzed 1 participants
581.0 [1]   (NA)
Present: Month 42 Number Analyzed 1 participants
334.0 [1]   (NA)
Present: Month 45 Number Analyzed 2 participants
526.5  (115.3)
Present: Month 48 Number Analyzed 1 participants
589.0 [1]   (NA)
Present: Month 51 Number Analyzed 2 participants
609.0  (287.1)
Present: Month 54 Number Analyzed 0 participants
Present: Month 57 Number Analyzed 1 participants
519.0 [1]   (NA)
Present: Month 60 Number Analyzed 0 participants
Present: Month 63 Number Analyzed 1 participants
712.0 [1]   (NA)
Present: Month 66 Number Analyzed 0 participants
Present: Month 69 Number Analyzed 1 participants
583.0 [1]   (NA)
Present: Month 72 Number Analyzed 0 participants
Present: Month 75 Number Analyzed 1 participants
969.0 [1]   (NA)
Present: Month 78 Number Analyzed 1 participants
787.0 [1]   (NA)
Present: Month 81 Number Analyzed 0 participants
Present: Month 84 Number Analyzed 1 participants
934.0 [1]   (NA)
Absent: Month 0 (Baseline) Number Analyzed 34 participants
320.0  (243.6)
Absent: Month 3 Number Analyzed 18 participants
342.1  (215.8)
Absent: Month 6 Number Analyzed 14 participants
342.1  (195.4)
Absent: Month 9 Number Analyzed 8 participants
474.3  (163.0)
Absent: Month 12 Number Analyzed 9 participants
426.2  (197.0)
Absent: Month 15 Number Analyzed 9 participants
507.0  (223.5)
Absent: Month 18 Number Analyzed 11 participants
406.5  (252.2)
Absent: Month 21 Number Analyzed 5 participants
554.3  (232.4)
Absent: Month 24 Number Analyzed 5 participants
525.4  (252.0)
Absent: Month 27 Number Analyzed 10 participants
612.4  (308.7)
Absent: Month 30 Number Analyzed 3 participants
376.0  (161.1)
Absent: Month 33 Number Analyzed 8 participants
477.4  (283.5)
Absent: Month 36 Number Analyzed 3 participants
508.0  (213.9)
Absent: Month 39 Number Analyzed 7 participants
550.6  (272.1)
Absent: Month 42 Number Analyzed 5 participants
887.1  (263.5)
Absent: Month 45 Number Analyzed 2 participants
1119.0  (435.6)
Absent: Month 48 Number Analyzed 3 participants
607.7  (451.0)
Absent: Month 51 Number Analyzed 2 participants
665.1  (630.9)
Absent: Month 54 Number Analyzed 2 participants
219.0  (42.4)
Absent: Month 57 Number Analyzed 1 participants
2070.0 [1]   (NA)
Absent: Month 60 Number Analyzed 2 participants
652.0  (711.3)
Absent: Month 63 Number Analyzed 1 participants
178.0 [1]   (NA)
Absent: Month 66 Number Analyzed 0 participants
Absent: Month 69 Number Analyzed 1 participants
1429.0 [1]   (NA)
Absent: Month 72 Number Analyzed 0 participants
Absent: Month 75 Number Analyzed 0 participants
Absent: Month 78 Number Analyzed 0 participants
Absent: Month 81 Number Analyzed 0 participants
Absent: Month 84 Number Analyzed 0 participants
[1]
Standard deviation could not be calculated since only one participant was available for analysis.
34.Secondary Outcome
Title Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
35.Secondary Outcome
Title Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: Log HIV-RNA copies/mL
At baseline Number Analyzed 40 participants
3.1  (1.7)
At Month 3 Number Analyzed 23 participants
1.8  (1.0)
At Month 6 Number Analyzed 17 participants
1.6  (0.6)
At Month 9 Number Analyzed 11 participants
1.4  (0.3)
At Month 12 Number Analyzed 10 participants
1.9  (0.8)
At Month 15 Number Analyzed 13 participants
1.6  (0.5)
At Month 18 Number Analyzed 12 participants
1.8  (0.7)
At Month 21 Number Analyzed 6 participants
1.9  (0.6)
At Month 24 Number Analyzed 7 participants
1.5  (0.4)
At Month 27 Number Analyzed 10 participants
1.4  (0.3)
At Month 30 Number Analyzed 3 participants
1.7  (0.4)
At Month 33 Number Analyzed 11 participants
1.3  (0.1)
At Month 36 Number Analyzed 4 participants
1.4  (0.2)
At Month 39 Number Analyzed 8 participants
1.4  (0.3)
At Month 42 Number Analyzed 6 participants
1.5  (0.3)
At Month 45 Number Analyzed 4 participants
1.3  (0.0)
At Month 48 Number Analyzed 4 participants
1.3  (0.0)
At Month 51 Number Analyzed 4 participants
1.3  (0.1)
At Month 54 Number Analyzed 2 participants
1.3  (0.0)
At Month 57 Number Analyzed 2 participants
1.3  (0.0)
At Month 60 Number Analyzed 2 participants
1.3  (0.0)
At Month 63 Number Analyzed 2 participants
1.3  (0.0)
At Month 66 Number Analyzed 0 participants
At Month 69 Number Analyzed 2 participants
1.3  (0.0)
At Month 72 Number Analyzed 0 participants
At Month 75 Number Analyzed 1 participants
1.3 [1]   (NA)
At Month 78 Number Analyzed 1 participants
1.3 [1]   (NA)
At Month 81 Number Analyzed 0 participants
At Month 84 Number Analyzed 1 participants
1.3 [1]   (NA)
[1]
Standard Deviation could not be calculated as only one participant was available for analysis.
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
Hide 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 (%)
Total   0/68 (0.00%) 
Hide Serious Adverse Events
Celsentri (Maraviroc) Tablets
Affected / at Risk (%)
Total   17/68 (25.00%) 
Eye disorders   
Glaucoma  1  1/68 (1.47%) 
Necrotising retinitis  1  1/68 (1.47%) 
Vitreous haemorrhage  1  1/68 (1.47%) 
Gastrointestinal disorders   
Intra-abdominal haemorrhage  1  1/68 (1.47%) 
Oesophageal varices haemorrhage  1  1/68 (1.47%) 
Upper gastrointestinal haemorrhage  1  1/68 (1.47%) 
Immune system disorders   
Immune reconstitution inflammatory syndrome  1  1/68 (1.47%) 
Infections and infestations   
Aspergillus infection  1  1/68 (1.47%) 
Cellulitis  1  1/68 (1.47%) 
Helicobacter infection  1  1/68 (1.47%) 
Pneumocystis jirovecii pneumonia  1  1/68 (1.47%) 
Progressive multifocal leukoencephalopathy  1  1/68 (1.47%) 
Syphilis  1  2/68 (2.94%) 
Urinary tract infection  1  1/68 (1.47%) 
Injury, poisoning and procedural complications   
Fracture  1  1/68 (1.47%) 
Heat illness  1  1/68 (1.47%) 
Spinal compression fracture  1  1/68 (1.47%) 
Subdural haematoma  1  1/68 (1.47%) 
Metabolism and nutrition disorders   
Dehydration  1  1/68 (1.47%) 
Diabetes mellitus  1  1/68 (1.47%) 
Hyperkalaemia  1  1/68 (1.47%) 
Musculoskeletal and connective tissue disorders   
Haemarthrosis  1  1/68 (1.47%) 
Lumbar spinal stenosis  1  1/68 (1.47%) 
Nervous system disorders   
Cerebral haemorrhage  1  1/68 (1.47%) 
Cerebral infarction  1  1/68 (1.47%) 
Psychiatric disorders   
Depressive symptom  1  1/68 (1.47%) 
Psychiatric symptom  1  1/68 (1.47%) 
Renal and urinary disorders   
Calculus urinary  1  1/68 (1.47%) 
Prerenal failure  1  1/68 (1.47%) 
Renal impairment  1  2/68 (2.94%) 
Renal tubular disorder  1  1/68 (1.47%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celsentri (Maraviroc) Tablets
Affected / at Risk (%)
Total   20/68 (29.41%) 
Blood and lymphatic system disorders   
Anaemia  1  1/68 (1.47%) 
Gastrointestinal disorders   
Diarrhoea  1  1/68 (1.47%) 
Dry mouth  1  1/68 (1.47%) 
Faeces soft  1  1/68 (1.47%) 
Gastrooesophageal reflux disease  1  1/68 (1.47%) 
Nausea  1  1/68 (1.47%) 
General disorders   
Malaise  1  1/68 (1.47%) 
Hepatobiliary disorders   
Hepatic function abnormal  1  1/68 (1.47%) 
Hepatic steatosis  1  1/68 (1.47%) 
Liver disorder  1  1/68 (1.47%) 
Infections and infestations   
Dermatophytosis of nail  1  2/68 (2.94%) 
Gastroenteritis  1  1/68 (1.47%) 
Herpes zoster  1  1/68 (1.47%) 
Nasopharyngitis  1  1/68 (1.47%) 
Oral candidiasis  1  2/68 (2.94%) 
Investigations   
White blood cell count increased  1  1/68 (1.47%) 
Metabolism and nutrition disorders   
Dyslipidaemia  1  2/68 (2.94%) 
Hyperlipidaemia  1  1/68 (1.47%) 
Hyperphosphatasaemia  1  1/68 (1.47%) 
Hypertriglyceridaemia  1  4/68 (5.88%) 
Hyperuricaemia  1  2/68 (2.94%) 
Hyponatraemia  1  1/68 (1.47%) 
Obesity  1  1/68 (1.47%) 
Musculoskeletal and connective tissue disorders   
Osteopenia  1  1/68 (1.47%) 
Plantar fasciitis  1  1/68 (1.47%) 
Spinal osteoarthritis  1  1/68 (1.47%) 
Nervous system disorders   
Cerebral arteriosclerosis  1  1/68 (1.47%) 
Dizziness  1  1/68 (1.47%) 
Headache  1  1/68 (1.47%) 
Skin and subcutaneous tissue disorders   
Drug eruption  1  1/68 (1.47%) 
Pruritus  1  1/68 (1.47%) 
Vascular disorders   
Hypertension  1  3/68 (4.41%) 
1
Term from vocabulary, MedDRA v21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00864474    
Other Study ID Numbers: A4001093
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: December 6, 2019
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020