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

Stopped early · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.

Key facts

Study ID: NCT00496782
Run by: ViiV Healthcare
People needed: 16
Starts: 2007-07-01
Expected to finish: 2008-10-01
Last updated by the study team: 2019-01-30

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit.
Have an HIV RNA ≥ 1000 copies/mL, at screening.
Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided.
That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance),
Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents.
Based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new OBT. This is defined as:
Having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or,
Having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the OBT not having used raltegravir in the past.

You may not qualify if…

Potentially life threatening (Grade 4) laboratory abnormality or medical condition.
Severe hepatic impairment (Child-Pugh classification B or C).
End stage renal disease or other disease states requiring dialysis therapy.

Where it is running

Pfizer Investigational Site — Miami, Florida, United States
Pfizer Investigational Site — Chicago, Illinois, United States
Pfizer Investigational Site — Topeka, Kansas, United States
Pfizer Investigational Site — Topeka, Kansas, United States
Pfizer Investigational Site — Detroit, Michigan, United States
Pfizer Investigational Site — Omaha, Nebraska, United States
Pfizer Investigational Site — Buffalo, New York, United States
Pfizer Investigational Site — Tulsa, Oklahoma, United States
Pfizer Investigational Site — Hampton, Virginia, United States
Pfizer Investigational Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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