Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS)
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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 | Intervention |
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Kaposi's Sarcoma |
Drug: Maraviroc |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Effects of Maraviroc (MVC) on HIV-related Kaposi's Sarcoma (KS) |
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
Estimated Enrollment: | 10 |
Study Start Date: | February 2011 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimental: Treatment Arm (single-arm study)
The subjects in this arm will receive Maraviroc as treatment, while continuing their current antiretroviral medication regimen.
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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)
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Show Detailed Description
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, California | |
San Francisco General Hospital, Clinical Trials Unit | |
San Francisco, California, United States, 94110 |
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) |
Publications:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01276236 History of Changes |
Other Study ID Numbers: | 10-02850, 10-02850, 2860798 |
Study First Received: | December 20, 2010 |
Last Updated: | May 3, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
Kaposi's Sarcoma Maraviroc CCR5 HIV |
Additional relevant MeSH terms:
Sarcoma, Kaposi Sarcoma Herpesviridae Infections DNA Virus Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue |
ClinicalTrials.gov processed this record on February 21, 2013