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
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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 ] |
| 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 ] |
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) |