N/A
N=68
Safety And Efficacy Of Maraviroc In Patients For HIV Patients (Regulatory Post Marketing Commitment Plan)
CCR5-tropic HIV-1 Infection
Bottom Line
View on ClinicalTrials.gov: NCT00864474 ↗Enrolled (actual)
68
Serious AEs
25.0%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants With Adverse Drug Reactions (ADRs) — 23.53 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CELSENTRI® Tablets (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- ViiV Healthcare
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs) |
23.53 | — |
| PRIMARY Number of Participants With Unknown Adverse Drug Reactions (ADRs) |
8 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Gender |
23.08; 33.33 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Age |
22.22; 40.00 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Inpatient or Outpatient Status |
0.00; 15.56; 42.86 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Ethnicity |
23.88; 0.00 | — |
| 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 |
18.75; 25.00 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor HIV Infection Duration |
0.00; 0.00; 50.00; 22.58 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Allergies |
18.52; 38.46; 100.00 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Comorbidities |
15.38; 25.45 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Renal Impairment |
20.97; 50.00 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hepatic Impairment |
21.74; 27.27 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Presence or Absence of Hemophilia |
22.95; 28.57 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Daily Dose of Celsentri |
0; 16.67; 35.71 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Number of Concomitant Anti-HIV Drugs Use |
0.00; 23.53; 25.00; 27.78 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Centers for Disease Control and Prevention (CDC) Classification |
20.69; 20.00; 29.03; 0.00 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor as Per Presence or Absence of Concomitant Therapies |
20.00; 38.46 | — |
| 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 |
21.82; 30.77 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Total Number of Days of Administration of Celsentri |
8.82; 1.67; 7.69; 8.57 | — |
| PRIMARY Percentage of Participants With Adverse Drug Reactions (ADRs): Factor Mean Total Dose of Celsentri |
7.35; 3.28; 0.00; 17.07 | — |
| PRIMARY Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Immune Function |
— | — |
| PRIMARY Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Hepatic Function |
3 | — |
| PRIMARY Number of Adverse Drug Reactions (ADRs) Considered to Have Occurred Due to Effect of Celsentri on Cardiovascular Effects |
— | — |
| SECONDARY Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor Gender |
3.1; 1.9; 1.6; 1.4; 1.9; 1.7 | — |
| SECONDARY Mean Number of Cluster of Differentiation of More Than 4 (CD4+) Lymphocyte Count: Factor Gender |
301.2; 318.2; 319.2; 405.7; 384.0; 440.9 | — |
| SECONDARY Mean Number of Plasma Human Immuno-Deficiency Virus-Ribosomal Ribonucleic Acid (HIV-RNA) Copies: Factor The Presence or Absence of Comorbidities |
2.8; 1.9; 1.8; 1.5; 2.1; 1.6 | — |
| SECONDARY Mean Number of CD4+ Lymphocyte Counts: Fcator The Presence or Absence of Comorbidities |
294.2; 282.0; 284.9; 361.5; 303.3; 422.9 | — |
| SECONDARY Mean Number of Plasma HIV-RNA Copies: Factor The Centers for Disease Control and Prevention (CDC) Classification |
3.4; 1.6; 1.5; 1.3; 1.5; 1.5 | — |
| SECONDARY Mean Number of CD4+ Lymphocyte Counts: Factor The Centers for Disease Control and Prevention (CDC) Classification |
347.0; 416.2; 428.3; 457.4; 524.8; 441.2 | — |
| SECONDARY Mean Number of Plasma HIV-RNA Copies: Factor The Presence or Absence of History of Therapies for HIV Infection |
2.4; 1.6; 1.7; 1.4; 1.8; 1.6 | — |
| SECONDARY Mean Number of CD4+ Lymphocyte Counts: Factor Presence or Absence of History of Therapies for HIV Infection |
334.8; 263.0; 297.6; 393.7; 373.2; 443.2 | — |
| 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 |
3.6; 2.4; 1.5; 1.3; 3.9; 1.6 | — |
| SECONDARY Mean Number of CD4+ Lymphocyte: Factor The Presence or Absence of Use of Cytochrome P450 3A4 (CYP3A4) Enzyme Inducer Taken Along With Celsentri |
200.7; 193.0; 212.0; 223.0; 4.0; 231.3 | — |
| SECONDARY Number of Participants With Tropism Switch From CCR5- to CXCR4-Tropic Variants |
— | — |
| SECONDARY Mean Number of Plasma HIV-RNA Copies for Participants Who Took Concomitant Therapies Along With Celsentri |
3.1; 1.8; 1.6; 1.4; 1.9; 1.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00864474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.