Maraviroc Compassionate Use - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00719823

Purpose

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

Condition	Intervention	Phase
Human Immunodeficiency Virus Type 1	Drug: Maraviroc	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Maraviroc Compassionate Use

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Maraviroc Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
Have only CCR5-tropic HIV-1 virus
CD4+ cell count < 200 cells/mm3

Exclusion Criteria:

CXCR4- or dual/mixed-tropic HIV-1 virus
Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness
Patients who are pregnant or breast feeding an infant or planning to become pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719823

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:	A4001068
Study First Received:	July 18, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00719823
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Maraviroc Compassionate Use

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on January 13, 2009