NCT00634959

Brief Summary

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)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_2 hiv

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2 hiv

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
Last Updated

November 10, 2010

Status Verified

November 1, 2010

First QC Date

March 5, 2008

Last Update Submit

November 9, 2010

Conditions

HIV

Keywords

HIV InfectionsTreatment Naïve

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in viral load

    Day 11

  • UK-427,857 pharmacokinetics

    Days 1-11

Secondary Outcomes (11)

  • Physical examination

    Days 1, 11, 40

  • 12-lead ECG

    Days 1-11 and Day 40

  • Relationship of change in viral load (baseline to Day 11) versus mean receptor saturation (Day 10)

    Days 1-11

  • Time course of viral load from baseline to follow-up

    Days 1-13 and Days 15, 19, 22, 25, 40

  • CCR5 receptor saturation

    Days 1, 5, 10, 11, 13, 15, 19, 40

  • +6 more secondary outcomes

Study Arms (5)

1

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

2

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

3

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

4

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

5

PLACEBO COMPARATOR
Other: Placebo

Interventions

Maraviroc (UK-427,857)DRUG

150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only)

Also known as: Celsentri, Selzentry
1
PlaceboOTHER

Matching placebo oral tablet on Days 1-10 (fed and fasted)

5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Birmingham, Alabama, 35294-2050, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Cologne, 50931, Germany

Location

Pfizer Investigational Site

Frankfurt, 60596, Germany

Location

Pfizer Investigational Site

Hamburg, 20099, Germany

Location

Pfizer Investigational Site

London, NW3 2QG, United Kingdom

Location

Pfizer Investigational Site

London, SW10 9NH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 13, 2008

Study Start

July 1, 2003

Study Completion

December 1, 2003

Last Updated

November 10, 2010

Record last verified: 2010-11

Locations

DE(3)GB(2)US(2)