A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B

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NCT01327547

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Study Location
The Office of Dr. Franco Antonio Felizarta, M.D.
Bakersfield, California, 93301, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Coinfection
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

- HIV coinfected with HCV and/or HBV.

- Undetectable HIV-1 RNA for at least 3 months prior to the screening visit

- Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.

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


- Currently receiving maraviroc.


- Active opportunistic infections.


- ALT and/or AST >5x upper limit of normal.


- Direct bilirubin >1.5x upper limit of normal.


- Severe or decompensated liver disease.


- Liver disease unrelated to viral hepatitis infection.

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HIV CoinfectionA Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
NCT01327547
  1. Bakersfield, California
  2. Los Angeles, California
  3. Oakland, California
  4. Sacramento, California
  5. Sacramento, California
  6. San Francisco, California
  7. San Francisco, California
  8. Miami, Florida
  9. Tampa, Florida
  10. Wilton Manors, Florida
  11. Augusta, Georgia
  12. Iowa City, Iowa
  13. Detroit, Michigan
  14. Newark, New Jersey
  15. New York, New York
  16. New York, New York
  17. New York, New York
  18. Valhalla, New York
  19. Charlotte, North Carolina
  20. Clackamas, Oregon
  21. Portland, Oregon
  22. Dallas, Texas
  23. Dallas, Texas
  24. San Antonio, Texas
  25. Brno,
  26. Lyon cedex 4,
  27. Paris CEDEX 14,
  28. Paris,
  29. Berlin,
  30. Bonn,
  31. Hamburg,
  32. Hamburg,
  33. Koeln,
  34. Muenchen,
  35. Budapest,
  36. Wroclaw, Dolnoslaskie
  37. Bydgoszcz,
  38. Warszawa,
  39. Ponce,
  40. San Juan,
  41. San Juan,
  42. Barcelona,
  43. Cordoba,
  44. Madrid,
  45. Sevilla,
  46. Valencia,
  47. London,
  48. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
Official Title  ICMJE A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus
Brief Summary To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV Coinfection
Intervention  ICMJE
  • Drug: Maraviroc
    150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
    Other Name: Selzentry, Celsentri
  • Drug: Placebo
    150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
Study Arms  ICMJE
  • Experimental: 1.0
    Intervention: Drug: Maraviroc
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications *

*   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: April 9, 2015)		138
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2011)		120
Actual Study Completion Date  ICMJE March 24, 2015
Actual Primary Completion Date April 23, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV coinfected with HCV and/or HBV.
  • Undetectable HIV-1 RNA for at least 3 months prior to the screening visit
  • Treatment with current antiretroviral therapy (3-6 drugs excluding low-dose ritonavir) for at least 5 months.

Exclusion Criteria:

  • Currently receiving maraviroc.
  • Active opportunistic infections.
  • ALT and/or AST >5x upper limit of normal.
  • Direct bilirubin >1.5x upper limit of normal.
  • Severe or decompensated liver disease.
  • Liver disease unrelated to viral hepatitis infection.
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 Czechia,   France,   Germany,   Hungary,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01327547
Other Study ID Numbers  ICMJE A4001098
2010-021994-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 November 2017

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