A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Expanded access is currently available for this treatment.

Verified by Pfizer, December 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00801515

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Study Start Date:	January 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

150 mg twice per day

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801515

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4001090
Study First Received:	December 2, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00801515
Health Authority:	Canada: Therapeutic Products Directorate (TPD)

Keywords provided by Pfizer:

Compassionate
HIV
CCR5

Study placed in the following topic categories:

HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on January 16, 2009