Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay

PHASE1TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
HIV Infections
Interventions
DRUG

maraviroc

Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

PROCEDURE

Trofile Assay and HIV RNA quantification assay

Trofile Assay and HIV RNA quantification assay

Trial Locations (10)

14215

Pfizer Investigational Site, Buffalo

23666

Pfizer Investigational Site, Hampton

33137

Pfizer Investigational Site, Miami

48202

Pfizer Investigational Site, Detroit

60613

Pfizer Investigational Site, Chicago

66606

Pfizer Investigational Site, Topeka

74135

Pfizer Investigational Site, Tulsa

66606-1670

Pfizer Investigational Site, Topeka

68198-5400

Pfizer Investigational Site, Omaha

H2L 5B1

Pfizer Investigational Site, Montreal

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

ViiV Healthcare

INDUSTRY