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A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Expanded access is no longer available for this treatment.
Information provided by:
ViiV Healthcare Identifier:
First received: December 2, 2008
Last updated: July 21, 2011
Last verified: July 2011
This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.

Condition Intervention Phase
Drug: Maraviroc
Phase 3

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Resource links provided by NLM:

Further study details as provided by ViiV Healthcare:

Study Start Date: August 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Maraviroc
    150 mg twice per day
    Other Name: Celsentri

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients having completed study A4001029 in Canada and still deriving clinical benefit.

Exclusion Criteria:

  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 identifier: NCT00801515

Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
ViiV Healthcare
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00801515     History of Changes
Other Study ID Numbers: A4001090 
Study First Received: December 2, 2008
Last Updated: July 21, 2011
Health Authority: Canada: Therapeutic Products Directorate (TPD)

Keywords provided by ViiV Healthcare:

Additional relevant MeSH terms:
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on October 21, 2016