A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00801515
First received: December 2, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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
HIV
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  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: NCT00801515

Locations
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3G 1A4
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: 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:
Compassionate
HIV
CCR5

ClinicalTrials.gov processed this record on September 30, 2014