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
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: Open Label Treatment Access: Maraviroc
Phase 3

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Study Start Date: November 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Open Label Treatment Access: Maraviroc
    Oral dosing twice daily. The dose will depend on the optimized background therapy.
    Other Name: Maraviroc, Celsentri, Selzentry
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992654

Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00992654     History of Changes
Other Study ID Numbers: A4001096, A4001050
Study First Received: October 8, 2009
Last Updated: November 15, 2010
Health Authority: India: Institutional Review Board

Keywords provided by ViiV Healthcare:
Open Label Access Program
Treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014