Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)

• Status: Completed
• Trial end date: 2015-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Pfizer; ViiV Healthcare
• Treatments: Maraviroc

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