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

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ClinicalTrials.gov Identifier: NCT01276236
Recruitment Status : Unknown
Verified July 2014 by University of California, San Francisco.
Recruitment status was:  Enrolling by invitation
First Posted : January 13, 2011
Last Update Posted : July 24, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this 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.

Condition or disease Intervention/treatment
Kaposi's Sarcoma Drug: Maraviroc

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)
Study Start Date : February 2011
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : April 2015


Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment Arm (single-arm study)
The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.
Drug: Maraviroc

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.

Other Name: Selzentry(Celsentri outside US)


Outcome Measures

Primary Outcome Measures :
  1. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 1 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 1 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  2. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 2 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 2 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  3. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 4 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 4 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  4. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 8 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 8 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  5. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 16 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 16 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  6. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 36 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 36 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  7. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 56 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 56 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  8. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 76 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 76 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.

  9. Change in Kaposi's Sarcoma Lesion Burden between Baseline and Week 96 [ Time Frame: Evaluations of the lesions will occur at baseline (week 0) and at week 96 ]
    The subjects' Kaposi's sarcoma related lesions will be evaluated during each visit for an increase or decrease in the number of lesions and whether the quality of the lesions show improvement or worsening of the condition.


Secondary Outcome Measures :
  1. Effects of Maraviroc on CCR5 and KSHV levels in lesional skin. [ Time Frame: Week 0 (baseline), and week 96 or at the end of the therapy if it is discontinued early. ]
    A biopsy will be taken from the subjects' lesions at baseline and at the end of the study to determine whether there has been a change in CCR5 receptor levels or KSHV levels.

  2. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 4 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 4. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  3. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 16 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 16. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  4. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 36 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 36. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  5. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 56 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 56. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  6. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 76 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 76. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  7. Change in CD4 count, and HIV viral load with Maraviroc from Baseline to Week 96 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 96. ]
    Blood samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in CD4 count or HIV viral load.

  8. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 1 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 1. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  9. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 2 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 2. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  10. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 4 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 4. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  11. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 16 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 16. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  12. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 36 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 36. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  13. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 56 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 56. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  14. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 76 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 76. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  15. Effects on KSHV Viral Load with Maraviroc treatment from Baseline to Week 96 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline) and 96. ]
    Blood and saliva samples will be obtained from the subjects throughout the study at different points to assess if there are any changes in KSHV viral load.

  16. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 1 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 1. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  17. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 2 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 2. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  18. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 4 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 4. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  19. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 16 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 16. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  20. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 36 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 36. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  21. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 56 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 56. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  22. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 76 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 76. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  23. Effects of Maraviroc on CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells from Baseline to Week 96 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 96. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in CCR5 receptor expression in T and B lymphocytes, monocytes, and natural killer cells.

  24. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 1 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 1. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  25. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 2 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 2. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  26. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 4 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 4. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  27. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 16 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 16. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  28. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 36 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 36. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  29. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 56 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 56. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  30. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 76 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 76. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.

  31. Changes in T Cell activation and exhaustion with Maraviroc treatment between Baseline and Week 96 [ Time Frame: Data will be collected on this measure during the subjects' visits on Weeks 0 (baseline), and 96. ]
    Blood samples will be obtained from the subjects throughout the study and cryopreserved to assess if there are any changes in T cell activation and exhaustion.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276236


Locations
United States, California
San Francisco General Hospital, Clinical Trials Unit
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Pfizer
ViiV Healthcare
Investigators
Principal Investigator: Patrick Unemori, MD University of California, San Francisco; San Francisco General Hospital (SFGH)
Principal Investigator: Toby Maurer, MD University of California, San Francisco; San Francisco General Hospital (SFGH)
More Information

Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01276236     History of Changes
Other Study ID Numbers: 10-02850
10-02850 ( Registry Identifier: IRB Number from UCSF CHR )
2860798 ( Other Identifier: FDA IND Exemption Reference ID )
First Posted: January 13, 2011    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014

Keywords provided by University of California, San Francisco:
Kaposi's Sarcoma
Maraviroc
CCR5
HIV

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents