Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)
Condition: Kaposi's Sarcoma
MeSH terms: Sarcoma, Kaposi; Sarcoma
Intervention: Maraviroc
Intervention description: FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.
Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.
Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions.
Intervention MeSH terms: Maraviroc
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kaposi's Sarcoma; Maraviroc; CCR5; HIV

Summary:

      The purpose of this pilot study is to determine whether Maraviroc is effective in the
      treatment of Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected, as documented by any licensed ELISA test kit and confirmed by Western
             blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA,
             or a second antibody test by a method other than ELISA is acceptable as an alternative
             confirmatory test.

          -  Active biopsy confirmed KS

          -  Screening plasma HIV RNA < 75 copies/mL

          -  Patients have unremitting KS. Unremitting is defined as having active biopsy confirmed
             KS in spite of having had sustained HIV RNA < 75 copies/mL for 24 prior months.
             Isolated values that are detectable but < 500 copies will be allowed as long as the
             plasma HIV RNA levels before and after this time point are undetectable.

          -  >90% adherence to therapy within the preceding 30 days, as determined by self-report.

          -  Both male and female subjects are eligible. Females of childbearing potential must
             have a negative serum pregnancy test at screening and agree to use a double-barrier
             method of contraception throughout the study period.

          -  Ability and willingness of subject or legal guardian/representative to provide
             informed consent

        Exclusion Criteria:

          -  Patients who are intending to modify antiretroviral therapy in the next 24 weeks for
             any reason.

          -  Serious illness requiring hospitalization or parental antibiotics within preceding 3
             months.

          -  Concurrent treatment with immunomodulatory drugs or therapies, or exposure to any
             immunomodulatory drug or therapy in past 16 weeks.

          -  Prior exposure to CCR5 inhibitors

          -  Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000
             cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute.

          -  Elevated transaminases greater than 2.5 times the upper limit of normal.

          -  Evidence of cirrhosis

          -  Pregnant or breastfeeding women

          -  Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen.

          -  Local therapy for any KS index lesion in preceding 60 days, unless lesion has clearly
             progressed with enlargement since the local therapy