Prospective Observational Epidemiologic Study of Maraviroc's Safety - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00665561

Purpose

The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

Condition	Intervention	Phase
Human Immunodeficiency Virus	Drug: Maraviroc along with an optimized background antiretroviral drug regimen Drug: Optimized background antiretroviral drug regimen without maraviroc	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	An International, Multicenter, Prospective Observational Study Of The Safety Of Maraviroc Used With Optimized Background Therapy In Treatment-Experienced HIV-1 Infected Patients

Further study details as provided by Pfizer:

Primary Outcome Measures:

CDC Category C AIDS defining infections, Viral encephalitis, Rhabdomyolysis, Liver failure, Liver related deaths [ Time Frame: Followed till 6 months after drug discontinuation up to a total of 5 years. ] [ Designated as safety issue: Yes ]
All Malignancies (AIDS defining and non-AIDS defining), Myocardial ischemia or infarction, All cause mortality [ Time Frame: Followed for a total of up to 5 years regardless of the time of drug discontinuaion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

There are no Secondary Outcomes for this study. [ Time Frame: 0 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	October 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Maraviroc exposed	Drug: Maraviroc along with an optimized background antiretroviral drug regimen Maraviroc prescribed per approved local label.
Maraviroc unexposed	Drug: Optimized background antiretroviral drug regimen without maraviroc Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.

Detailed Description:

All patients meeting the study eligibility criteria at participating sites will be invited to participate.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Treatment experienced, HIV-1 infected patients in routine clinical practice.

Criteria

Inclusion Criteria:

Treatment experienced, HIV-1 infected patients
18 years or older
Receive an approved assay for determination of HIV-1 tropism

Exclusion Criteria:

Pregnant or lactating
Using CCR5 inhibitor other than maraviroc

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665561

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 250 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4001067
Study First Received:	April 23, 2008
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00665561 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Maraviroc, HIV-1, Safety, Non-interventional

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:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009