HIV-1 Infection
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted 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 Rescriptor® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Interventions
DRUGRescriptor
RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-HIV drugs.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.
Exclusion criteria
Patients not administered Rescriptor®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Unlisted Adverse Drug Reaction. | One Year | Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document). |
| Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). | One year | Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies. Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts. Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category. |
Participant flow
Recruitment details
08 December 2003 to 31 March 2009, a total of two centers in Japan
Participants by arm
| Arm | Count |
|---|---|
| Delavirdine Mesilate RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Delavirdine Mesilate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment Japan | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 2 / 3 |
Outcome results
Primary
Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category).
Improvement of number of HIV-RNA copies; Improvement is measured by general evaluation of decrease in HIV-RNA copies. Improvement of CD4 counts; Improvement is measured by general evaluation of increase in CD4 counts. Not progress in HIV classification (severity of CDC category); Subjects were classified based on the severity of CDC category as mild (Category A), moderate (Category B), and severe (Category C). No change categories from Category A to Category B / Category C, or from Category B to Category C in CDC category.
Time frame: One year
Population: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Delavirdine Mesilate | Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). | Number of HIV-RNA | 3 participants |
| Delavirdine Mesilate | Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). | CD4 | 2 participants |
| Delavirdine Mesilate | Number of Participants Who Improved in Number of HIV- Ribonucleic Acid (RNA) Copies, Cluster of Differentiation 4(CD4) Count, and Not Progress in HIV Classification: Centers for Disease Control and Prevention Clinical Category (CDC Category). | CDC category | 3 participants |
Primary
Number of Participants Who Reported Unlisted Adverse Drug Reaction.
Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).
Time frame: One Year
Population: The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delavirdine Mesilate | Number of Participants Who Reported Unlisted Adverse Drug Reaction. | 0 participants |