Trial Outcomes & Findings for Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients (NCT NCT00823966)

Results Overview

Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).

Recruitment status

COMPLETED

Target enrollment

3 participants

Primary outcome timeframe

One Year

Results posted on

2010-07-05

Participant Flow

08 December 2003 to 31 March 2009, a total of two centers in Japan

Participant milestones

Participant milestones
Measure	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."
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delavirdine Mesilate n=3 Participants 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."
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Japan	3 participants n=5 Participants

PRIMARY outcome

Timeframe: One Year

Population: The safety analysis population included enrolled subjects who had received at least 1 confirmed, administration of delavirdine mesylate.

Adverse drug reaction that is not listed in the Japanese Package Insert(Same as Local product Document).

Outcome measures

Outcome measures
Measure	Delavirdine Mesilate n=3 Participants 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."
Number of Participants Who Reported Unlisted Adverse Drug Reaction.	0 participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Delavirdine Mesilate n=3 Participants 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."
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
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
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

Adverse Events

Delavirdine Mesilate

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delavirdine Mesilate n=3 participants at risk 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."
Infections and infestations Pneumocystis jiroveci pneumonia	33.3% 1/3 • Number of events 1 • One year
Respiratory, thoracic and mediastinal disorders hypoxia	33.3% 1/3 • Number of events 1 • One year

Other adverse events

Other adverse events
Measure	Delavirdine Mesilate n=3 participants at risk 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."
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • One year
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • One year

Additional Information

Pfizer ClinicalTraials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place