Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

November 9, 2010 updated by: ViiV Healthcare

An Investigation Into The Effects Of Food And Dose Regimen On Viral Load Response In HIV Infected Patients On Short-Term Monotherapy With UK-427,857 (Maraviroc)

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60596
        • Pfizer Investigational Site
      • Hamburg, Germany, 20099
        • Pfizer Investigational Site
      • Koeln, Germany, 50931
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • London, United Kingdom, SW10 9NH
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2050
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic HIV-1 infected male and female patients
  • Weight between 50 and 100kg and within the permitted range for their height
  • Patients with virus that targets CCR5 receptor

Exclusion Criteria:

  • Patients with a CD4 count <250 cells/mm3 or HIV viral load <5000 copies/mL
  • Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
  • Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
  • Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Experimental: 2
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Experimental: 3
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Experimental: 4
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
100 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
300 mg oral tablet once daily while fasted on Days 1-10
Other Names:
  • Celsentri, Selzentry
Drug: Maraviroc (UK-427,857)
150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only)
Other Names:
  • Celsentri, Selzentry
Placebo Comparator: 5
Other: Placebo
Matching placebo oral tablet on Days 1-10 (fed and fasted)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in viral load
Time Frame: Day 11
Day 11
UK-427,857 pharmacokinetics
Time Frame: Days 1-11
Days 1-11

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Physical examination
Time Frame: Days 1, 11, 40
Days 1, 11, 40
12-lead ECG
Time Frame: Days 1-11 and Day 40
Days 1-11 and Day 40
Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)
Time Frame: Days 1-11
Days 1-11
Time course of viral load from baseline to follow-up
Time Frame: Days 1-13 and Days 15, 19, 22, 25, 40
Days 1-13 and Days 15, 19, 22, 25, 40
CCR5 receptor saturation
Time Frame: Days 1, 5, 10, 11, 13, 15, 19, 40
Days 1, 5, 10, 11, 13, 15, 19, 40
Adverse events
Time Frame: Days 1-40
Days 1-40
Relationship of change in viral load (baseline to Day 11) versus baseline susceptibility (IC50 and IC90)
Time Frame: Days 1-11
Days 1-11
Laboratory safety
Time Frame: Days 1, 3, 7, 11, 15, 40
Days 1, 3, 7, 11, 15, 40
Relationship of change in viral load (baseline to Day 11) versus average and trough plasma concentrations (Day 10)
Time Frame: Days 1-11
Days 1-11
Supine/standing blood pressure and pulse rate
Time Frame: Days 1-11 and Day 40
Days 1-11 and Day 40
Time to rebound of viral load
Time Frame: Days 1-13 and Days 15, 19, 22, 25, 40
Days 1-13 and Days 15, 19, 22, 25, 40

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4001015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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