Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00823966
First received: January 14, 2009
Last updated: June 2, 2010
Last verified: June 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: March 4, 2010
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Case-Only; Time Perspective: Prospective |
| Condition: |
HIV-1 Infection |
| Intervention: |
Drug: Rescriptor |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 08 December 2003 to 31 March 2009, a total of two centers in Japan |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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." |
Participant Flow: Overall Study
| Delavirdine Mesilate | |
|---|---|
| STARTED | 3 |
| COMPLETED | 3 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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." |
Baseline Measures
| Delavirdine Mesilate | |
|---|---|
|
Number of Participants
[units: participants] |
3 |
|
Age
[units: participants] |
|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
|
Gender
[units: participants] |
|
| Female | 0 |
| Male | 3 |
|
Region of Enrollment
[units: participants] |
|
| Japan | 3 |
Outcome Measures
| 1. Primary: | Number of Participants Who Reported Unlisted Adverse Drug Reaction. [ Time Frame: One Year ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Participants Who Reported Unlisted Adverse Drug Reaction. |
| Measure Description | Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document). |
| Time Frame | One Year |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate. |
Reporting Groups
| Description | |
|---|---|
| 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." |
Measured Values
| Delavirdine Mesilate | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
3 |
|
Number of Participants Who Reported Unlisted Adverse Drug Reaction.
[units: participants] |
0 |
No statistical analysis provided for Number of Participants Who Reported Unlisted Adverse Drug Reaction.
| 2. 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). [ Time Frame: One year ] |
| Measure Type | Primary |
|---|---|
| Measure Title | 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). |
| Measure Description |
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 |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated. |
Reporting Groups
| Description | |
|---|---|
| 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." |
Measured Values
| Delavirdine Mesilate | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
3 |
|
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).
[units: participants] |
|
| Number of HIV-RNA | 3 |
| CD4 | 2 |
| CDC category | 3 |
No statistical analysis provided for 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).
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| There is not enough data to analyze on the efficacy and safety of delavirdine mesylate in the 3 subjects with HIV infection assessed during this study. |
Results Point of Contact:
Name/Title: Pfizer ClinicalTraials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTraials.govCallCenter@pfizer.com
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTraials.govCallCenter@pfizer.com
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00823966 History of Changes |
| Other Study ID Numbers: | A4351010 |
| Study First Received: | January 14, 2009 |
| Results First Received: | March 4, 2010 |
| Last Updated: | June 2, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency (PMDA) |