CCR5-tropic HIV-1 Infection
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first CELSENTRI® Tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
DRUGCELSENTRI® Tablets
CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food.
Sponsors
Pfizer
ViiV Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.
Exclusion criteria
Patients not administered CELSENTRI® Tablets.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of renal impairment are reported to assess presence or absence of renal impairment as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hepatic impairment are reported to assess presence or absence of hepatic impairment as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean daily dose of Celsentri are reported to assess mean daily dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by number of concomitant anti-HIV treatment are reported to assess number of concomitant anti-HIV treatment as a risk factor for ADR. Concomitant drugs refers to the drugs other than Celsentri. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged\>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant CYP3A4 enzyme inducer use are reported to assess presence or absence of concomitant CYP3A enzyme inducer use as a risk factor for ADR. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducer for enzyme CYP3A4. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by total number of days of administration of Celsentri are reported to assess total number of days of administration of Celsentri as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by mean total dose of Celsentri are reported to assess mean total dose of Celsentri as a risk factor for ADR. One tablet of Celsentri had a dose of 150 mg. |
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. |
| Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. |
| Percentage of Participants With Adverse Drug Reactions (ADRs) | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. |
| Number of Participants With Unknown Adverse Drug Reactions (ADRs) | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. Unknown ADRs were the ADRs those were not listed on the package insert. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by gender are reported to assess gender as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by age are reported to assess age as a risk factor for ADR. \>= refers to greater than or equal to. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by inpatient or outpatient status are reported to assess inpatient or outpatient status as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by ethnicity are reported to assess ethnicity as a risk factor for ADR. |
| Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of history of therapies for HIV Infection are reported to assess presence or absence of history of therapies for HIV Infection as a risk factor for ADR. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by HIV infection duration are reported to assess HIV infection duration as a risk factor for ADR. Unknown: participants for which the duration of HIV infection was not known. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of allergies are reported to assess presence or absence of allergies as a risk factor for ADR. Unknown: participants for which the presence or absence of allergies was not known. |
| Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities | From April 2009 to December 2018 (up to approximately 8 years 8 months) | An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | CD4+ Lymphocyte were counted by CD4 cells per cubic millimeter (cells/mm\^3). CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. |
| Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. |
| Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. |
| Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as follows: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute (primary) HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged \>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. |
| Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. Participants are divided into 3 categories as per CDC classification based on the level of HIV infection as: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in an adult or adolescent aged\>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the AIDS diagnostic criteria, corresponding to conventional AIDS. Once criteria C has occurred, the person will remain in Category C even if symptoms are alleviated. |
| Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. |
| Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | CD4 cells are the white blood cells and act as a laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. |
| Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies/mL. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of majority of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. |
| Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | CD4 cells are the white blood cells and act as laboratory marker providing an indication of immune functioning. A higher number is associated with better immune functioning. CYP3A4 is an important enzyme in the body, mainly found in the liver and in the intestine. This enzyme is responsible for metabolism of many of drugs. Many of the food substances and commonly used drugs act as inducers of enzyme CYP3A4. |
| Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants | From April 2009 to December 2018 (up to approximately 8 years 8 months) | CCR5= C-C chemokine receptor type 5 and CXCR4= C-X-C chemokine receptor type 4. Tropism switch is the mutation of CCR5-tropic HIV-1 to a CXCR4-using virus. |
| Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | — |
| Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84 | HIV-RNA copy numbers were measured employing the TaqMan assay with the lower limit of detection of 40 copies per milliliter (copies/mL). The reported data for plasma HIV-RNA copies was calculated after logarithmic conversion. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celsentri (Maraviroc) Tablets 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. | 68 |
| Total | 68 |
Baseline characteristics
| Characteristic | Celsentri (Maraviroc) Tablets |
|---|---|
| Age, Continuous | 42.31 years STANDARD_DEVIATION 12.37 |
| Race/Ethnicity, Customized Japanese | 67 Participants |
| Race/Ethnicity, Customized Others | 1 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 68 |
| other Total, other adverse events | 20 / 68 |
| serious Total, serious adverse events | 17 / 68 |
Outcome results
Primary
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects
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)
Population: The safety analysis set included all participants who met the criteria for participants and were confirmed to have received at least one dose of Celsentri.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects | 0 ADRs |
Primary
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function | 3 ADRs |
Primary
Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function | 0 ADRs |
Primary
Number of Participants With Unknown Adverse Drug Reactions (ADRs)
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Number of Participants With Unknown Adverse Drug Reactions (ADRs) | 8 Participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs)
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs) | 23.53 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age | >=15 and less than(<) 65 years | 22.22 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age | >=65 and less than or equal to (<=) 70 years | 40.00 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of concomitant therapies are reported to assess presence or absence of concomitant therapies as a risk factor for ADR. Concomitant therapies were the treatments taken by participants to treat comorbid conditions.
Time frame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant therapies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies | Concomitant Therapies: Absent | 20.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies | Concomitant Therapies: Present | 38.46 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification
An ADR:any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by physician.Participants are divided into 3 categories as per CDC classification based on level of HIV infection: Category A= asymptomatic HIV-1 infection, persistent generalized lymphadenopathy and acute(primary)HIV-1 infection with accompanying illness or history of acute HIV-1 infection in adult or adolescent aged\>=13 years, Category B: conditions attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or the conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection in an HIV-infected adolescent or adult; and Category C: clinical conditions listed in the acquired immunodeficiency syndrome (AIDS) diagnostic criteria, corresponding to conventional AIDS. Unknown: Participants for which CDC classification was not described.
Time frame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per CDC classification.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | CDC category A | 20.69 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | CDC category B | 20.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | CDC category C | 29.03 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification | Unknown | 0.00 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per ethnicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity | Japanese | 23.88 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity | Others | 0.00 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, number analyzed ('n') signifies participants who were evaluable for this outcome measure as per gender.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender | Males | 23.08 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender | Females | 33.33 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per duration of HIV infection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | <=1 year | 0.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | greater than (>) 4 and <=5 years | 0.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | >5 years | 50.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration | Unknown | 22.58 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per inpatient or outpatient status.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status | Inpatient | 0.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status | Outpatient | 15.56 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status | Inpatient and outpatient | 42.86 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. 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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean daily dose of Celsentri.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | <2 tablets | 0 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | 2 tablets | 16.67 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri | >2 tablets | 35.71 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. 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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per mean total dose of Celsentri.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | 4 to <=360 tablets | 7.35 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | > 360 and <=730 tablets | 3.28 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | > 730 and <=1460 tablets | 0.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri | > 1460 and <=21632 tablets | 17.07 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by 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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per number of concomitant anti-HIV treatments use.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | 1 drug | 0.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | 2 drugs | 23.53 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | 3 drugs | 25.00 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use | >=4 drugs | 27.78 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of allergies.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | Allergies: Absent | 18.52 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | Allergies: Present | 38.46 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies | Allergies: Unknown | 100.00 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of comorbidities are reported to assess presence or absence of comorbidities as a risk factor for ADR. Comorbidity referred to the presence of co-existing or additional diseases along with HIV infection.
Time frame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of comorbidities.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities | Comorbidities: Absent | 15.38 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities | Comorbidities: Present | 25.45 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. In this outcome measure percentage of participants with ADRs categorized by presence or absence of hemophilia are reported to assess presence or absence of hemophilia as a risk factor for ADR. Hemophilia is a bleeding disorder that slows the blood clotting process. Participants with this condition experience prolonged bleeding or oozing following an injury, surgery, or having a tooth pulled.
Time frame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hemophilia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia | Hemophilia: Absent | 22.95 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia | Hemophilia: Present | 28.57 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of hepatic impairment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment | Hepatic Impairment: Absent | 21.74 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment | Hepatic Impairment: Present | 27.27 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of renal impairment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment | Renal Impairment: Absent | 20.97 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment | Renal Impairment: Present | 50.00 percentage of participants |
Primary
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
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of concomitant CYP3A enzyme inducer use.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | CYP3A Enzyme Inducer Use: Absent | 21.82 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | CYP3A Enzyme Inducer Use: Present | 30.77 percentage of participants |
Primary
Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri
An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician. 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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per total number of days of administration of Celsentri.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | 2 to <=180 days | 8.82 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | > 180 and <=365 days | 1.67 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | > 365 and <=730 days | 7.69 percentage of participants |
| Celsentri (Maraviroc) Tablets | Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri | > 730 and <= 2704 days | 8.57 percentage of participants |
Primary
Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection
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)
Population: The safety analysis set included participants who were infected with HIV, had received Celsentri tablet at least once and visited physician after first dose of treatment. Here, 'n' signifies participants who were evaluable for this outcome measure as per presence or absence of history of therapies for HIV Infection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection | History of Therapies for HIV Infection: Absent | 18.75 percentage of participants |
| Celsentri (Maraviroc) Tablets | Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection | History of Therapies for HIV Infection: Present | 25.00 percentage of participants |
Secondary
Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 0 | 334.8 CD4 cells/mm^3 | Standard Deviation 266.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 3 | 263.0 CD4 cells/mm^3 | Standard Deviation 203.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 6 | 297.6 CD4 cells/mm^3 | Standard Deviation 214.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 9 | 393.7 CD4 cells/mm^3 | Standard Deviation 216.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 12 | 373.2 CD4 cells/mm^3 | Standard Deviation 176.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 15 | 443.2 CD4 cells/mm^3 | Standard Deviation 240.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 18 | 393.3 CD4 cells/mm^3 | Standard Deviation 244.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 21 | 520.6 CD4 cells/mm^3 | Standard Deviation 253.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 24 | 496.2 CD4 cells/mm^3 | Standard Deviation 236.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 27 | 607.1 CD4 cells/mm^3 | Standard Deviation 327 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 30 | 376.0 CD4 cells/mm^3 | Standard Deviation 161.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 33 | 412.1 CD4 cells/mm^3 | Standard Deviation 224.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 36 | 540.0 CD4 cells/mm^3 | Standard Deviation 191.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 39 | 599.9 CD4 cells/mm^3 | Standard Deviation 234.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 42 | 804.7 CD4 cells/mm^3 | Standard Deviation 363.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 45 | 822.8 CD4 cells/mm^3 | Standard Deviation 429.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 48 | 603.0 CD4 cells/mm^3 | Standard Deviation 368.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 51 | 637.1 CD4 cells/mm^3 | Standard Deviation 401.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 54 | 219.0 CD4 cells/mm^3 | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 57 | 1294.5 CD4 cells/mm^3 | Standard Deviation 1096.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 60 | 652.0 CD4 cells/mm^3 | Standard Deviation 711.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 63 | 445.0 CD4 cells/mm^3 | Standard Deviation 377.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 69 | 1006.0 CD4 cells/mm^3 | Standard Deviation 598.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 75 | 969.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 78 | 787.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Present: Month 84 | 934.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 0 | 225.6 CD4 cells/mm^3 | Standard Deviation 153.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 3 | 382.2 CD4 cells/mm^3 | Standard Deviation 237 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 6 | 371.0 CD4 cells/mm^3 | Standard Deviation 175.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 9 | 426.8 CD4 cells/mm^3 | Standard Deviation 187.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 12 | 394.8 CD4 cells/mm^3 | Standard Deviation 293.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 15 | 306.5 CD4 cells/mm^3 | Standard Deviation 430.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 21 | 353.0 CD4 cells/mm^3 | Standard Deviation 475.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 24 | 14.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 27 | 660.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 33 | 801.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 36 | 382.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 39 | 236.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection | Absent: Month 42 | 746.0 CD4 cells/mm^3 | — |
Secondary
Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 0 (Baseline) | 347.0 CD4 cells/mm^3 | Standard Deviation 222.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 3 | 416.2 CD4 cells/mm^3 | Standard Deviation 221.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 6 | 428.3 CD4 cells/mm^3 | Standard Deviation 175.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 9 | 457.4 CD4 cells/mm^3 | Standard Deviation 147.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 12 | 524.8 CD4 cells/mm^3 | Standard Deviation 209.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 15 | 441.2 CD4 cells/mm^3 | Standard Deviation 183.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 18 | 401.3 CD4 cells/mm^3 | Standard Deviation 221.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 21 | 777.5 CD4 cells/mm^3 | Standard Deviation 125.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 24 | 567.5 CD4 cells/mm^3 | Standard Deviation 307.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 27 | 784.8 CD4 cells/mm^3 | Standard Deviation 232.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category Month 33 | 531.7 CD4 cells/mm^3 | Standard Deviation 214.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 36 | 616.5 CD4 cells/mm^3 | Standard Deviation 195.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 39 | 719.3 CD4 cells/mm^3 | Standard Deviation 126.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 42 | 617.0 CD4 cells/mm^3 | Standard Deviation 245.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 45 | 621.3 CD4 cells/mm^3 | Standard Deviation 183.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 48 | 596.0 CD4 cells/mm^3 | Standard Deviation 9.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 51 | 609.0 CD4 cells/mm^3 | Standard Deviation 287.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 57 | 519.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 63 | 712.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 69 | 583.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 75 | 969.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 78 | 787.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A : Month 84 | 934.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 0 (Baseline) | 264.3 CD4 cells/mm^3 | Standard Deviation 221.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 3 | 227.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 6 | 122.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 15 | 447.5 CD4 cells/mm^3 | Standard Deviation 337.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 18 | 371.0 CD4 cells/mm^3 | Standard Deviation 319.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 24 | 207.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 27 | 180.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 30 | 218.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 33 | 137.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 39 | 201.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 42 | 1221.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 45 | 1427.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 48 | 610.0 CD4 cells/mm^3 | Standard Deviation 637.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 51 | 219.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 60 | 149.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 63 | 178.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 0 (Baseline) | 255.9 CD4 cells/mm^3 | Standard Deviation 268.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 3 | 165.0 CD4 cells/mm^3 | Standard Deviation 129.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 6 | 207.0 CD4 cells/mm^3 | Standard Deviation 166.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 9 | 315.3 CD4 cells/mm^3 | Standard Deviation 264.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 12 | 243.2 CD4 cells/mm^3 | Standard Deviation 155.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 15 | 389.2 CD4 cells/mm^3 | Standard Deviation 354.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 18 | 396.1 CD4 cells/mm^3 | Standard Deviation 276.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 21 | 308.4 CD4 cells/mm^3 | Standard Deviation 221.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 24 | 412.3 CD4 cells/mm^3 | Standard Deviation 313.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 27 | 411.7 CD4 cells/mm^3 | Standard Deviation 224 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 30 | 455.0 CD4 cells/mm^3 | Standard Deviation 120.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 33 | 398.8 CD4 cells/mm^3 | Standard Deviation 265.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 36 | 384.5 CD4 cells/mm^3 | Standard Deviation 3.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 39 | 519.1 CD4 cells/mm^3 | Standard Deviation 259.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 42 | 848.8 CD4 cells/mm^3 | Standard Deviation 360.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 51 | 1111.2 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 54 | 219.0 CD4 cells/mm^3 | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 57 | 2070.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 60 | 1155.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 69 | 1429.0 CD4 cells/mm^3 | — |
Secondary
Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 57 | 519.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 63 | 712.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 0 (Baseline) | 294.2 CD4 cells/mm^3 | Standard Deviation 249.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 3 | 282.0 CD4 cells/mm^3 | Standard Deviation 205 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 6 | 284.9 CD4 cells/mm^3 | Standard Deviation 196.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 9 | 361.5 CD4 cells/mm^3 | Standard Deviation 199 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 12 | 303.3 CD4 cells/mm^3 | Standard Deviation 170.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 15 | 422.9 CD4 cells/mm^3 | Standard Deviation 286.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 18 | 401.6 CD4 cells/mm^3 | Standard Deviation 254.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 21 | 308.4 CD4 cells/mm^3 | Standard Deviation 221.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 24 | 427.3 CD4 cells/mm^3 | Standard Deviation 282.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 27 | 558.7 CD4 cells/mm^3 | Standard Deviation 399.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 30 | 376.0 CD4 cells/mm^3 | Standard Deviation 161.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 33 | 357.0 CD4 cells/mm^3 | Standard Deviation 211.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 36 | 415.7 CD4 cells/mm^3 | Standard Deviation 54 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 39 | 476.4 CD4 cells/mm^3 | Standard Deviation 243.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 42 | 813.2 CD4 cells/mm^3 | Standard Deviation 419.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 45 | 1017.5 CD4 cells/mm^3 | Standard Deviation 579.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 48 | 603.0 CD4 cells/mm^3 | Standard Deviation 451.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 51 | 714.1 CD4 cells/mm^3 | Standard Deviation 454.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 54 | 219.0 CD4 cells/mm^3 | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 57 | 2070.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 60 | 652.0 CD4 cells/mm^3 | Standard Deviation 711.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 63 | 178.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 69 | 1429.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 75 | 969.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 78 | 787.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Present: Month 84 | 934.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 0 (Baseline) | 325.6 CD4 cells/mm^3 | Standard Deviation 226.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 3 | 388.0 CD4 cells/mm^3 | Standard Deviation 262.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 6 | 401.4 CD4 cells/mm^3 | Standard Deviation 210.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 9 | 523.7 CD4 cells/mm^3 | Standard Deviation 167.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 12 | 707.0 CD4 cells/mm^3 | Standard Deviation 75 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 15 | 419.7 CD4 cells/mm^3 | Standard Deviation 167 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 18 | 301.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 21 | 777.5 CD4 cells/mm^3 | Standard Deviation 125.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 27 | 693.0 CD4 cells/mm^3 | Standard Deviation 75.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 33 | 605.8 CD4 cells/mm^3 | Standard Deviation 234 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 36 | 755.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 39 | 788.5 CD4 cells/mm^3 | Standard Deviation 55.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 42 | 758.5 CD4 cells/mm^3 | Standard Deviation 17.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 45 | 628.0 CD4 cells/mm^3 | Standard Deviation 258.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 48 | 603.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 51 | 406.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities | Comorbidities -Absent: Month 69 | 583.0 CD4 cells/mm^3 | — |
Secondary
Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 57 | 519.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 0 (Baseline) | 200.7 CD4 cells/mm^3 | Standard Deviation 220.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 3 | 193.0 CD4 cells/mm^3 | Standard Deviation 217.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 6 | 212.0 CD4 cells/mm^3 | Standard Deviation 233.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 9 | 223.0 CD4 cells/mm^3 | Standard Deviation 183 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 12 | 4.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 15 | 231.3 CD4 cells/mm^3 | Standard Deviation 247.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 18 | 248.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 21 | 17.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 24 | 182.0 CD4 cells/mm^3 | Standard Deviation 237.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 33 | 367.7 CD4 cells/mm^3 | Standard Deviation 29 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 36 | 478.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 39 | 581.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 42 | 334.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 45 | 526.5 CD4 cells/mm^3 | Standard Deviation 115.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 48 | 589.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 51 | 609.0 CD4 cells/mm^3 | Standard Deviation 287.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 63 | 712.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 69 | 583.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 75 | 969.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 78 | 787.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 84 | 934.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 0 (Baseline) | 320.0 CD4 cells/mm^3 | Standard Deviation 243.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 3 | 342.1 CD4 cells/mm^3 | Standard Deviation 215.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 6 | 342.1 CD4 cells/mm^3 | Standard Deviation 195.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 9 | 474.3 CD4 cells/mm^3 | Standard Deviation 163 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 12 | 426.2 CD4 cells/mm^3 | Standard Deviation 197 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 15 | 507.0 CD4 cells/mm^3 | Standard Deviation 223.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 18 | 406.5 CD4 cells/mm^3 | Standard Deviation 252.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 21 | 554.3 CD4 cells/mm^3 | Standard Deviation 232.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 24 | 525.4 CD4 cells/mm^3 | Standard Deviation 252 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 27 | 612.4 CD4 cells/mm^3 | Standard Deviation 308.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 30 | 376.0 CD4 cells/mm^3 | Standard Deviation 161.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 33 | 477.4 CD4 cells/mm^3 | Standard Deviation 283.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 36 | 508.0 CD4 cells/mm^3 | Standard Deviation 213.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 39 | 550.6 CD4 cells/mm^3 | Standard Deviation 272.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 42 | 887.1 CD4 cells/mm^3 | Standard Deviation 263.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 45 | 1119.0 CD4 cells/mm^3 | Standard Deviation 435.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 48 | 607.7 CD4 cells/mm^3 | Standard Deviation 451 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 51 | 665.1 CD4 cells/mm^3 | Standard Deviation 630.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 54 | 219.0 CD4 cells/mm^3 | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 57 | 2070.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 60 | 652.0 CD4 cells/mm^3 | Standard Deviation 711.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 63 | 178.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 69 | 1429.0 CD4 cells/mm^3 | — |
Secondary
Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender
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
Population: Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom info sirmation about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 63 | 445.0 CD4 cells/mm^3 | Standard Deviation 377.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 24 | 427.3 CD4 cells/mm^3 | Standard Deviation 282.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 0 (Baseline) | 301.2 CD4 cells/mm^3 | Standard Deviation 244.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 3 | 318.2 CD4 cells/mm^3 | Standard Deviation 221.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 6 | 319.2 CD4 cells/mm^3 | Standard Deviation 201.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 9 | 405.7 CD4 cells/mm^3 | Standard Deviation 197.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 12 | 384.0 CD4 cells/mm^3 | Standard Deviation 228.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 15 | 440.9 CD4 cells/mm^3 | Standard Deviation 259.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 18 | 393.3 CD4 cells/mm^3 | Standard Deviation 244.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 21 | 464.7 CD4 cells/mm^3 | Standard Deviation 302.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 27 | 612.4 CD4 cells/mm^3 | Standard Deviation 308.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 30 | 376.0 CD4 cells/mm^3 | Standard Deviation 161.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 33 | 447.5 CD4 cells/mm^3 | Standard Deviation 243 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 36 | 500.5 CD4 cells/mm^3 | Standard Deviation 175.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 39 | 554.4 CD4 cells/mm^3 | Standard Deviation 252.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 42 | 794.9 CD4 cells/mm^3 | Standard Deviation 326.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 45 | 822.8 CD4 cells/mm^3 | Standard Deviation 429.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 48 | 603.0 CD4 cells/mm^3 | Standard Deviation 368.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 51 | 637.1 CD4 cells/mm^3 | Standard Deviation 401.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 54 | 219.0 CD4 cells/mm^3 | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 57 | 1294.5 CD4 cells/mm^3 | Standard Deviation 1096.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 60 | 652.0 CD4 cells/mm^3 | Standard Deviation 711.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 69 | 1006.0 CD4 cells/mm^3 | Standard Deviation 598.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 75 | 969.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 78 | 787.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Males: Month 84 | 934.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Females: Month 0 (Baseline) | 335.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Females: Month 3 | 122.0 CD4 cells/mm^3 | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender | Females: Month 15 | 197.0 CD4 cells/mm^3 | — |
Secondary
Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for CDC Classification at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 0 (Baseline) | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 0 (Baseline) | 3.4 Log HIV-RNA copies/mL | Standard Deviation 1.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 3 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 6 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 9 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 12 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 15 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 18 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 21 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 24 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 27 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 36 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 39 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 42 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 51 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 75 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 78 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category A: Month 84 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 3 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 6 | 1.5 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 15 | 2.1 Log HIV-RNA copies/mL | Standard Deviation 1.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 18 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 24 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 27 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 30 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 33 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 39 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 42 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 45 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 51 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 60 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category B: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 0 (Baseline) | 3.0 Log HIV-RNA copies/mL | Standard Deviation 1.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 3 | 2.3 Log HIV-RNA copies/mL | Standard Deviation 1.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 6 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 9 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 12 | 2.3 Log HIV-RNA copies/mL | Standard Deviation 1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 15 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 18 | 2.0 Log HIV-RNA copies/mL | Standard Deviation 0.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 21 | 2.1 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 24 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 27 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 30 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 33 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 36 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 39 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 42 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 51 | 1.5 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 54 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 60 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification | CDC category C: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
Secondary
Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence therapies at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 21 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 24 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 0 (Baseline) | 2.4 Log HIV-RNA copies/mL | Standard Deviation 1.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 3 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 6 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 9 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 12 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 15 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 18 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 21 | 2.1 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 24 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 27 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 30 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 36 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 39 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 42 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 51 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 54 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 57 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 60 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 63 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 69 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 75 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 78 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Present: Month 84 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 0 (Baseline) | 4.7 Log HIV-RNA copies/mL | Standard Deviation 1.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 3 | 2.2 Log HIV-RNA copies/mL | Standard Deviation 1.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 6 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 9 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 12 | 2.0 Log HIV-RNA copies/mL | Standard Deviation 1.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 15 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 27 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 33 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 36 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 39 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection | Absent: Month 42 | 1.3 Log HIV-RNA copies/mL | — |
Secondary
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
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for presence or absence of CYP3A4 at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 15 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 0 (Baseline) | 3.6 Log HIV-RNA copies/mL | Standard Deviation 2.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 3 | 2.4 Log HIV-RNA copies/mL | Standard Deviation 2.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 6 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 9 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 12 | 3.9 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 18 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 21 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 24 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 36 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 39 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 42 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 48 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 51 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 75 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 78 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Present: Month 84 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 0 (Baseline) | 3.0 Log HIV-RNA copies/mL | Standard Deviation 1.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 3 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 6 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 9 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 12 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 15 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 18 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 21 | 2.0 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 24 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 27 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 30 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 36 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 39 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 42 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 51 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 54 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 60 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri | Absent: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
Secondary
Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri
Time frame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Population: The efficacy analysis set. Here, Overall Number of Participants Analyzed included participants evaluable for this measure. 'n' signifies participants who were evaluable for this measure at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 30 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At baseline | 3.1 Log HIV-RNA copies/mL | Standard Deviation 1.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 3 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 6 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 9 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 12 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 15 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 18 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 21 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 24 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 27 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 36 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 39 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 42 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 51 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 54 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 57 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 60 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 63 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 69 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 75 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 78 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri | At Month 84 | 1.3 Log HIV-RNA copies/mL | — |
Secondary
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender
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
Population: Efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, 'n' signifies participants who were evaluable for this measure for individual gender at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 54 | 219.0 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 42.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 0 (Baseline) | 3.1 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 1.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 3 | 1.9 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 6 | 1.6 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 9 | 1.4 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 12 | 1.9 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.8 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 15 | 1.7 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.5 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 18 | 1.8 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 21 | 1.9 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 24 | 1.5 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 27 | 1.4 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 30 | 1.7 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 33 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 36 | 1.4 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 39 | 1.4 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 42 | 1.5 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 45 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 48 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 51 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 57 | 1294.5 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 1096.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 60 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 63 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 69 | 1.3 Log HIV-RNA copies/milliliter(mL) | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 75 | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 78 | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Males: Month 84 | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Females: Month 0 (Baseline) | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Females: Month 3 | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender | Females: Month 15 | 1.3 Log HIV-RNA copies/milliliter(mL) | — |
Secondary
Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities
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
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here,'n' signifies participants who were evaluable for this measure for presence or absence of comorbidities at respective timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 0 (Baseline) | 2.8 Log HIV-RNA copies/mL | Standard Deviation 1.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 3 | 1.9 Log HIV-RNA copies/mL | Standard Deviation 1.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 6 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 9 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 12 | 2.1 Log HIV-RNA copies/mL | Standard Deviation 0.9 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 15 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 18 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 21 | 2.1 Log HIV-RNA copies/mL | Standard Deviation 0.7 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 24 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 27 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 30 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 36 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 39 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 42 | 1.6 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 48 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 51 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.1 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 54 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 60 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 75 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 78 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Present: Month 84 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 0 (Baseline) | 3.8 Log HIV-RNA copies/mL | Standard Deviation 1.6 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 3 | 1.8 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 6 | 1.4 Log HIV-RNA copies/mL | Standard Deviation 0.2 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 9 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 12 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 15 | 1.7 Log HIV-RNA copies/mL | Standard Deviation 0.4 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 18 | 2.4 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 21 | 1.5 Log HIV-RNA copies/mL | Standard Deviation 0.3 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 27 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 33 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 36 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 39 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 42 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 45 | 1.3 Log HIV-RNA copies/mL | Standard Deviation 0 |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 48 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 51 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 57 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 63 | 1.3 Log HIV-RNA copies/mL | — |
| Celsentri (Maraviroc) Tablets | Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities | Comorbidities-Absent: Month 69 | 1.3 Log HIV-RNA copies/mL | — |
Secondary
Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants
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)
Population: The efficacy analysis set included participants infected with HIV, had received Celsentri tablets at least once for HIV as primary indication and in whom information about number of CD4 or RNA copies was confirmed. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Celsentri (Maraviroc) Tablets | Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants | 0 Participants |