A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00992654
First received: October 8, 2009
Last updated: November 15, 2010
Last verified: November 2010

October 8, 2009
November 15, 2010
November 2009
February 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00992654 on ClinicalTrials.gov Archive Site
Not Provided
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A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
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

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.

Not Provided
Expanded Access
Phase 3
Not Provided
Human Immunodeficiency Virus (HIV)
Drug: Open Label Treatment Access: Maraviroc
Oral dosing twice daily. The dose will depend on the optimized background therapy.
Other Name: Maraviroc, Celsentri, Selzentry
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
Not Provided
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00992654
A4001096, A4001050
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP