A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

NCT00666705

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects between 18 and 55 years of age.

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


- Evidence or history of clinically significant disease or clinical findings at
screening

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
Official Title  ICMJE An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
Brief Summary An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.
Detailed Description Drug interaction study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Maraviroc
    300 milligrams(mg) every 12 hours Days 6-11
    Other Name: Selzentry, Celsentri
  • Drug: Maraviroc
    Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
  • Drug: Raltegravir
    Days 12-14: Raltegravir 400 milligrams(mg) every 12 hours, maraviroc 300 milligrams(mg) every 12 hours (AM doses only on Day 14)
  • Drug: Raltegravir
    400 milligrams(mg) every 12 hours Days 1-3 Followed by washout Days 4-5
Study Arms  ICMJE
  • Experimental: Maraviroc alone
    Intervention: Drug: Maraviroc
  • Experimental: Maraviroc + Raltegravir
    Interventions:
    • Drug: Maraviroc
    • Drug: Raltegravir
  • Experimental: Raltegravir alone
    Intervention: Drug: Raltegravir
Publications * Not Provided

*   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 23, 2008)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between 18 and 55 years of age.

Exclusion Criteria:

  • Evidence or history of clinically significant disease or clinical findings at screening
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666705
Other Study ID Numbers  ICMJE A4001082
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 January 2013

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