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Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects

NCT ID: NCT01290211

Last Updated: 2011-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Twice daily regimen

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

maraviroc 300 mg BID x 5 days

Fosamprenavir/ritonavir

Intervention Type DRUG

fosamprenavir/ritonavir 700/100 mg BID x 10 days

Maraviroc + Fosamprenavir/ritonavir

Intervention Type DRUG

maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days

Cohort 2

Once daily regimen

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

maraviroc 300 mg QD x 5 days

Fosamprenavir/ritonavir

Intervention Type DRUG

fosamprenavir/ritonavir 1400/100 mg QD x 10 days

Maraviroc + Fosamprenavir/ritonavir

Intervention Type DRUG

maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days

Interventions

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Maraviroc

maraviroc 300 mg BID x 5 days

Intervention Type DRUG

Fosamprenavir/ritonavir

fosamprenavir/ritonavir 700/100 mg BID x 10 days

Intervention Type DRUG

Maraviroc + Fosamprenavir/ritonavir

maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days

Intervention Type DRUG

Maraviroc

maraviroc 300 mg QD x 5 days

Intervention Type DRUG

Fosamprenavir/ritonavir

fosamprenavir/ritonavir 1400/100 mg QD x 10 days

Intervention Type DRUG

Maraviroc + Fosamprenavir/ritonavir

maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days

Intervention Type DRUG

Other Intervention Names

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Selzentry, Celsentri

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria

* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Positive result for HIV, Hepatitis B or Hepatitis C virus.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Known hypersensitivity or history of allergy to sulfonamides.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001103&StudyName=Pharmacokinetic%20Interaction%20Between%20Maraviroc%20And%20Fosamprenavir/Ritonavir%20In%20Healthy%20Subjects%20

To obtain contact information for a study center near you, click here.

Other Identifiers

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A4001103

Identifier Type: -

Identifier Source: org_study_id

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