Multicenter Pilot Study To Define The Marker As An Alternate For Tropism Assay
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: maraviroc; Trofile Assay and HIV RNA quantification assay
Intervention description: 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.; Trofile Assay and HIV RNA quantification assay
Intervention MeSH terms: Maraviroc
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 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.

        Exclusion Criteria:

          -  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.