Multicenter, Safety Study Of Maraviroc

NCT00478231

Last updated date
Study Location
Pfizer Investigational Site
Salvador, BA, 40110-160, Brazil
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acquired Immunodeficiency Syndrome, HIV Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Acquired Immunodeficiency Syndrome, HIV InfectionMulticenter, Safety Study Of Maraviroc
NCT00478231
  1. Salvador, BA
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  3. Belo Horizonte, MG
  4. Curitiba, PR
  5. Nova Iguaçu, RJ
  6. Porto Alegre, RS
  7. Florianopolis, SC
  8. Campinas, SP
  9. Campinas, SP
  10. Ribeirao Preto, SP
  11. Santo Andre, SP
  12. Sao Paulo, SP
  13. Sao Paulo, SP
  14. Sao Paulo, SP
  15. Sao Paulo, SP
  16. São Paulo, SP
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multicenter, Safety Study Of Maraviroc
Official Title  ICMJE A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc
Brief Summary To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acquired Immunodeficiency Syndrome
  • HIV Infection
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Maraviroc
Publications * Furtado J, Madruga JV, Bicudo EL, da Eira M, Lopes MI, Netto EM, Santini-Oliveira M, Leite OH, Machado AA, Tupinambas U, de Andrade Neto JL, Lima MP, Pedro Rde J, Miranda AF, Lewi DS, Santos BR, Portsmouth S, Wajsbrot DB, Cassoli LM. Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1203-10. doi: 10.1089/AID.2012.0330. Epub 2013 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2011)
209
Original Enrollment  ICMJE
 (submitted: May 22, 2007)
200
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00478231
Other Study ID Numbers  ICMJE A4001063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViiV Healthcare
Study Sponsor  ICMJE ViiV Healthcare
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account ViiV Healthcare
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP