Multicenter, Safety Study Of Maraviroc - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00478231

Purpose

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Condition	Intervention	Phase
Acquired Immunodeficiency Syndrome HIV Infection	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:	A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

Further study details as provided by Pfizer:

Primary Outcome Measures:

Primary endpoint of this study is to collect safety information in all subjects who receive at least one dose of study medication in all study visits (involving clinical and laboratorial data). [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in chemokine co-receptor tropism from screening to time of virologic failure will be reported for all subjects meeting the definition of virologic failure. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Secondary endpoints include the following efficacy variables: change in HIV-1 RNA levels from baseline, proportion of subjects achieving HIV-1 RNA levels below the limit of quantification, CD4 and CD8 cell counts and percent [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Time to virologic failure, and evolution of resistance to OBT in samples collected at time of virologic failure. [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Maraviroc Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Exclusion Criteria:

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478231

Locations

Brazil, BA
Pfizer Investigational Site
Salvador, BA, Brazil, 40110-160
Brazil, DF
Pfizer Investigational Site
Brasilia, DF, Brazil, 70351-580
Brazil, mg
Pfizer Investigational Site
Belo Horizonte, mg, Brazil, 30130-100
Brazil, PR
Pfizer Investigational Site
Curitiba, PR, Brazil, 80240-280
Brazil, RJ
Pfizer Investigational Site
Nova Iguaçu, RJ, Brazil, 26030-380
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90110-270
Brazil, SC
Pfizer Investigational Site
Florianopolis, SC, Brazil, 88025-301
Brazil, SP
Pfizer Investigational Site
Campinas, SP, Brazil, 13083-887
Pfizer Investigational Site
São Paulo, SP, Brazil, 04231-030
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01307-001
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04040-002
Pfizer Investigational Site
Ribeirao Preto, SP, Brazil, 14048900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04121-000
Pfizer Investigational Site
Santo Andre, SP, Brazil, 09060-650
Pfizer Investigational Site
Campinas, SP, Brazil, 13059-900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-900

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:	A4001063
Study First Received:	May 22, 2007
Last Updated:	May 5, 2009
ClinicalTrials.gov Identifier:	NCT00478231 History of Changes
Health Authority:	Brazil: National Ethics Committee (CONEP)

Keywords provided by Pfizer:

Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc
Treatment Experienced

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
Sexually Transmitted Diseases, Viral
Disease
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Pathologic Processes
HIV Infections
Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009