Clinical trial NCT00864474: Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
Official title: DRUG USE INVESTIGATION FOR HIV INFECTION PATIENTS OF MARAVIROC (REGULATORY POST MARKETING COMMITMENT PLAN).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CCR5-tropic HIV-1 Infection
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-03-18
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A4001093 prescribes the Maraviroc Tablets (CELSENTRI® Tablets).

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions (ADRs)
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Number of Participants With Unknown Adverse Drug Reactions (ADRs)
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Primary: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of History of Therapies for Human Immuno-Deficiency Virus (HIV) Infection
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: 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
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
Secondary outcomes:
measure: Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: 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
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
measure: Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants
timeFrame: From April 2009 to December 2018 (up to approximately 8 years 8 months)
measure: Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri
timeFrame: Month 0 (Baseline), 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: