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

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.

Timeline

Start

2011-03-09

Primary completion

2015-01-31

Completion

2015-04-30

Publications

• Background Engels EA, Pfeiffer RM, Goedert JJ, Virgo P, McNeel TS, Scoppa SM, Biggar RJ; HIV/AIDS Cancer Match Study. Trends in cancer risk among people with AIDS in the United States 1980-2002. AIDS. 2006 Aug 1;20(12):1645-54. doi: 10.1097/01.aids.0000238411.75324.59.
• Background Parkin DM, Nambooze S, Wabwire-Mangen F, Wabinga HR. Changing cancer incidence in Kampala, Uganda, 1991-2006. Int J Cancer. 2010 Mar 1;126(5):1187-95. doi: 10.1002/ijc.24838.
• Background Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.
• Background Nakano K, Isegawa Y, Zou P, Tadagaki K, Inagi R, Yamanishi K. Kaposi's sarcoma-associated herpesvirus (KSHV)-encoded vMIP-I and vMIP-II induce signal transduction and chemotaxis in monocytic cells. Arch Virol. 2003 May;148(5):871-90. doi: 10.1007/s00705-002-0971-7.
• Background Navenot JM, Wang ZX, Trent JO, Murray JL, Hu QX, DeLeeuw L, Moore PS, Chang Y, Peiper SC. Molecular anatomy of CCR5 engagement by physiologic and viral chemokines and HIV-1 envelope glycoproteins: differences in primary structural requirements for RANTES, MIP-1 alpha, and vMIP-II Binding. J Mol Biol. 2001 Nov 9;313(5):1181-93. doi: 10.1006/jmbi.2001.5086.
• Background Shao W, Fernandez E, Sachpatzidis A, Wilken J, Thompson DA, Schweitzer BI, Lolis E. CCR2 and CCR5 receptor-binding properties of herpesvirus-8 vMIP-II based on sequence analysis and its solution structure. Eur J Biochem. 2001 May;268(10):2948-59. doi: 10.1046/j.1432-1327.2001.02184.x.
• Background Nicholas J, Ruvolo VR, Burns WH, Sandford G, Wan X, Ciufo D, Hendrickson SB, Guo HG, Hayward GS, Reitz MS. Kaposi's sarcoma-associated human herpesvirus-8 encodes homologues of macrophage inflammatory protein-1 and interleukin-6. Nat Med. 1997 Mar;3(3):287-92. doi: 10.1038/nm0397-287.
• Background Boshoff C, Endo Y, Collins PD, Takeuchi Y, Reeves JD, Schweickart VL, Siani MA, Sasaki T, Williams TJ, Gray PW, Moore PS, Chang Y, Weiss RA. Angiogenic and HIV-inhibitory functions of KSHV-encoded chemokines. Science. 1997 Oct 10;278(5336):290-4. doi: 10.1126/science.278.5336.290.
• Background Kledal TN, Rosenkilde MM, Coulin F, Simmons G, Johnsen AH, Alouani S, Power CA, Luttichau HR, Gerstoft J, Clapham PR, Clark-Lewis I, Wells TN, Schwartz TW. A broad-spectrum chemokine antagonist encoded by Kaposi's sarcoma-associated herpesvirus. Science. 1997 Sep 12;277(5332):1656-9. doi: 10.1126/science.277.5332.1656.
• Background Moore PS, Chang Y. Detection of herpesvirus-like DNA sequences in Kaposi's sarcoma in patients with and those without HIV infection. N Engl J Med. 1995 May 4;332(18):1181-5. doi: 10.1056/NEJM199505043321801.
• Background Chang Y, Cesarman E, Pessin MS, Lee F, Culpepper J, Knowles DM, Moore PS. Identification of herpesvirus-like DNA sequences in AIDS-associated Kaposi's sarcoma. Science. 1994 Dec 16;266(5192):1865-9. doi: 10.1126/science.7997879.
• Background Cherqui S, Kingdon KM, Thorpe C, Kurian SM, Salomon DR. Lentiviral gene delivery of vMIP-II to transplanted endothelial cells and endothelial progenitors is proangiogenic in vivo. Mol Ther. 2007 Jul;15(7):1264-72. doi: 10.1038/sj.mt.6300183. Epub 2007 May 1.
• Background Dupont C, Vasseur E, Beauchet A, Aegerter P, Berthe H, de Truchis P, Zucman D, Rouveix E, Saiag P. Long-term efficacy on Kaposi's sarcoma of highly active antiretroviral therapy in a cohort of HIV-positive patients. CISIH 92. Centre d'information et de soins de l'immunodeficience humaine. AIDS. 2000 May 26;14(8):987-93. doi: 10.1097/00002030-200005260-00010.
• Background Nguyen HQ, Magaret AS, Kitahata MM, Van Rompaey SE, Wald A, Casper C. Persistent Kaposi sarcoma in the era of highly active antiretroviral therapy: characterizing the predictors of clinical response. AIDS. 2008 May 11;22(8):937-45. doi: 10.1097/QAD.0b013e3282ff6275.
• Background Cooley T, Henry D, Tonda M, Sun S, O'Connell M, Rackoff W. A randomized, double-blind study of pegylated liposomal doxorubicin for the treatment of AIDS-related Kaposi's sarcoma. Oncologist. 2007 Jan;12(1):114-23. doi: 10.1634/theoncologist.12-1-114.
• Background Cainelli F, Vallone A. Safety and efficacy of pegylated liposomal doxorubicin in HIV-associated Kaposi's sarcoma. Biologics. 2009;3:385-90. doi: 10.2147/btt.2009.3455. Epub 2009 Sep 15.
• Background Lichterfeld M, Qurishi N, Hoffmann C, Hochdorfer B, Brockmeyer NH, Arasteh K, Mauss S, Rockstroh JK; German Clinical AIDS Working Group (KAAD). Treatment of HIV-1-associated Kaposi's sarcoma with pegylated liposomal doxorubicin and HAART simultaneously induces effective tumor remission and CD4+ T cell recovery. Infection. 2005 Jun;33(3):140-7. doi: 10.1007/s15010-005-4099-z.
• Background Saran FH, Adamietz IA, Thilmann C, Mose S, Bottcher HD. HIV-associated cutaneous Kaposi's sarcoma--palliative local treatment by radiotherapy. Acta Oncol. 1997;36(1):55-8. doi: 10.3109/02841869709100733.
• Background McCormick SU. Intralesional vinblastine injections for the treatment of oral Kaposi's sarcoma: report of 10 patients with 2-year follow-up. J Oral Maxillofac Surg. 1996 May;54(5):583-7; discussion 588-9. doi: 10.1016/s0278-2391(96)90637-0.
• Background Maurer T, Ponte M, Leslie K. HIV-associated Kaposi's sarcoma with a high CD4 count and a low viral load. N Engl J Med. 2007 Sep 27;357(13):1352-3. doi: 10.1056/NEJMc070508. No abstract available.

Drugs

Indications