Back to resultsA Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Primary Purpose
Human Immunodeficiency Virus (HIV)
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Open Label Treatment Access: Maraviroc
Sponsored by
About this trial
This is an expanded access trial for Human Immunodeficiency Virus (HIV) focused on measuring Open Label Access Program, Treatment experienced
Eligibility Criteria
Inclusion Criteria:
- Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
- Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.
Exclusion Criteria:
- Subjects who discontinued in A4001050 study.
- Unable to provide consent.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00992654
First Posted
October 8, 2009
Last Updated
September 25, 2018
Sponsor
ViiV Healthcare
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00992654
Brief Title
A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Official Title
A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
Pfizer
4. Oversight
5. Study Description
Brief Summary
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Open Label Access Program, Treatment experienced
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Open Label Treatment Access: Maraviroc
Other Intervention Name(s)
Maraviroc, Celsentri, Selzentry
Intervention Description
Oral dosing twice daily. The dose will depend on the optimized background therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.
Exclusion Criteria:
Subjects who discontinued in A4001050 study.
Unable to provide consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001096&StudyName=A%20Treatment%20Access%20Program%20To%20Provide%20Maraviroc%20To%20Eligible%20Adult%20Patients%20Completing%20A4001050%20Study%20Until%20Commercial%20Availability%20Of%20Mara
Description
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Learn more about this trial
A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
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