Clinical Trials

MainTitle

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

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
Pfizer

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT00864474

First received: March 17, 2009
Last updated: December 6, 2019
Last Verified: December 2019
History of Changes
Purpose

Purpose

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

Condition Intervention
CCR5-tropic HIV-1 Infection

Drug : CELSENTRI® Tablets

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MARAVIROC (REGULATORY POST MARKETING COMMITMENT PLAN).

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Percentage of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Cardiovascular Effects [ Time Frame: From April 2009 to December 2018 (up to approximately 8 years 8 months) ]
    An ADR was any untoward medical occurrence attributed to Celsentri tablets in a participant who received Celsentri tablets. Relatedness to Celsentri tablets was assessed by the physician.
Secondary Outcome Measures:
  • Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender [ 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 ]
    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.
  • Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ Time Frame: 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 [ 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 ]

Enrollment: 68
Study Start Date: March 31, 2010
Study Completion Date: December 24, 2018
Primary Completion Date: December 24, 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Maraviroc Tablets
Patients administered.
Drug: CELSENTRI® Tablets

CELSENTRI ® Tablets 150mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage is 300 mg twice daily. Maraviroc must be used in combination with other anti-HIV drugs. The dosage may be adjusted according to co-administered medical products. Maraviroc can be taken with or without food".

Other Name: CELSENTRI® Tablets, maraviroc, Selzentry

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.

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Probability Sample  

Study Population

The patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets).

Criteria

Inclusion Criteria:
Patients need to be administered CELSENTRI® Tablets in order to be enrolled in the surveillance.
Exclusion Criteria:
Patients not administered CELSENTRI® Tablets.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864474

Sponsors and Collaborators

ViiV Healthcare
Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center Pfizer
More Information

More Information

Additional Information:

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

Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT00864474   History of Changes  
Other Study ID Numbers: A4001093  
Study First Received: March 17, 2009  
Last Updated: December 6, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Additional relevant MeSH terms:
Infection
Maraviroc

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.