NCT00643643

Brief Summary

To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects 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
41

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
3 countries

6 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

October 1, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
Last Updated

November 10, 2010

Status Verified

November 1, 2010

Enrollment Period

8 months

First QC Date

March 19, 2008

Last Update Submit

November 9, 2010

Conditions

HIV Infections

Keywords

HIVTreatment Naïve

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in viral load

    Day 11

  • Pharmacokinetic profile of UK-427,857

    Days 1 and 10

  • Receptor saturation

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

Secondary Outcomes (10)

  • 12-lead electrocardiography

    Days 1-11 and Day 40

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

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

  • Time to rebound of viral load

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

  • The relationship of change in viral load (from baseline to day 11) versus average (Days 1-11) and trough (Day 10) plasma concentrations

    Days 1-11

  • The relationship of change in viral load (from baseline to day 11) versus mean receptor saturation (Day 10)

    Days 1-11

  • +5 more secondary outcomes

Study Arms (5)

A

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

B

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

C

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

D

EXPERIMENTAL
Drug: Maraviroc (UK-427,857)

E

PLACEBO COMPARATOR
Other: Placebo

Interventions

Maraviroc (UK-427,857)DRUG

25 mg oral tablet once daily for 10 days

Also known as: Celsentri, Selzentry
A
PlaceboOTHER

Matching placebo oral tablet twice daily for 10 days

Also known as: Celsentri, Selzentry
E

Eligibility Criteria

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

You may qualify if:

  • Male with HIV or surgically sterilized female with HIV showing no symptoms of HIV
  • Weight between 50 and 90kg and within the permitted range for their height

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Bonn, 53105, Germany

Location

Pfizer Investigational Site

Cologne, 50924, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

Utrecht, 3584 CX, Netherlands

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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 26, 2008

Study Start

October 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

November 10, 2010

Record last verified: 2010-11

Locations

NL(1)DE(3)GB(2)