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

An observational study of HIV-1 Infection, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: HIV-1 Infection
What is being tested?: Rescriptor
Type of treatment: Pill or oral medicine
How many people: 3 participants
Where: No sites listed yet
Study dates: Dec 2003to Mar 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor).

Who may be able to join

Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.

Who cannot join

Patients not administered Rescriptor®.

About this study

Official title: Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)

Read the 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.

Conditions: HIV-1 Infection
Being tested: Rescriptor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RescriptorDrug
Also called Rescripter
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."

Study groups in NCT00823966
Study group	Role	What they receive
Delavirdine Mesilate		Patients administered. Receives: Drug: Rescriptor

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: One Year
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.
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2003Mar 2009

First posted16 Jan 2009 (estimated)
Study startDec 2003
Primary completionMar 2009
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00823966
Sponsor's protocol ID: A4351010
Status last verified: Jun 2010
First submitted: 14 Jan 2009
Last updated: 5 Jul 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation For Rescriptor (Regulatory Post Marketing Commitment Plan)
ClinicalTrials.gov ID: NCT00823966
Acronym / sponsor ID: A4351010
Conditions: HIV-1 Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 16 Jan 2009 (estimated)
Results: Posted 5 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Delavirdine Mesilate	–	Drug: RescriptorPatients administered.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The patients whom an investigator involving A4351010 prescribes the Delavirdine Mesilate(Rescriptor).

Key inclusion criteria (1 listed)

Patients need to be administered Rescriptor® in order to be enrolled in the surveillance.

Key exclusion criteria (1 listed)

Patients not administered Rescriptor®.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RescriptorAlso: RescripterRESCRIPTOR® 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."	Drug	Delavirdine Mesilate

Primary outcome

Number of Participants Who Reported Unlisted Adverse Drug Reaction.
Time frame: 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).
Time frame: 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.

Results and safety

Results posted to the registry on 5 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delavirdine Mesilate	3	3

Primary outcome: Number of Participants Who Reported Unlisted Adverse Drug Reaction.

Time frame: One Year. Number. Unit: participants

Measure	Delavirdine Mesilate n = 3
Value	0

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

Primary outcome: 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. Number. Unit: participants

Measure	Delavirdine Mesilate n = 3
Number of HIV-RNA	3
CD4	2
CDC category	3

Population analysed: The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.

Adverse events

Time frame: One year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delavirdine Mesilate	2 of 3 (66.7%)	2 of 3 (66.7%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for HIV-1 Infection

RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1 Infection, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reported Unlisted Adverse Drug Reaction. (time frame: One Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00823966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2010.