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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00478231 |
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 |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Brazil, BA | |
Pfizer Investigational Site | Recruiting |
Salvador, BA, Brazil, 40110-160 | |
Brazil, DF | |
Pfizer Investigational Site | Active, not recruiting |
Brasília, DF, Brazil, 70351-580 | |
Brazil, mg | |
Pfizer Investigational Site | Active, not recruiting |
Belo Horizonte, mg, Brazil, 30130-100 | |
Brazil, PR | |
Pfizer Investigational Site | Active, not recruiting |
Curitiba, PR, Brazil, 80430-040 | |
Brazil, RJ | |
Pfizer Investigational Site | Recruiting |
Nova Iguaçu, RJ, Brazil, 26030-380 | |
Brazil, RS | |
Pfizer Investigational Site | Active, not recruiting |
Porto Alegre, RS, Brazil, 90110-270 | |
Brazil, SC | |
Pfizer Investigational Site | Recruiting |
Florianópolis, SC, Brazil, 88025-301 | |
Brazil, SP | |
Pfizer Investigational Site | Active, not recruiting |
Campinas, SP, Brazil, 13083-887 | |
Pfizer Investigational Site | Recruiting |
São Paulo, SP, Brazil, 04230-000 | |
Pfizer Investigational Site | Recruiting |
São Paulo, SP, Brazil, 01307-001 | |
Pfizer Investigational Site | Active, not recruiting |
São Paulo, SP, Brazil, 04040-002 | |
Pfizer Investigational Site | Recruiting |
Ribeirão Preto, SP, Brazil, 14048-900 | |
Pfizer Investigational Site | Active, not recruiting |
São Paulo, SP, Brazil, 04121-000 | |
Pfizer Investigational Site | Recruiting |
Santo André, SP, Brazil, 09060-650 | |
Pfizer Investigational Site | Recruiting |
Campinas, SP, Brazil, 13059-900 | |
Pfizer Investigational Site | Recruiting |
São Paulo, SP, Brazil, 01246-900 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4001063 |
Study First Received: | May 22, 2007 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00478231 |
Health Authority: | Brazil: National Ethics Committee (CONEP) |
Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Pathologic Processes Disease Slow Virus Diseases |
Immune System Diseases Syndrome Lentivirus Infections Infection |