Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.

Summary

Kaposi sarcoma (KS) has an unpredictable course, patients with disseminated KS starting combined Antiretroviral Therapy can develop Immune Reconstitution Syndrome (IRIS), with a severe clinical presentation and high mortality (severe-IRIS-KS). The objective of this study is to evaluate the presence of Severe IRIS-KS and it´s attributable mortality in patients with AIDS and disseminated KS with the use of valganciclovir prior to the initiation of cART compared with the standard management of immediate cART initiation.

Timeline

Start

2015-10-01

Primary completion

2019-08-26

Completion

2019-08-26

Publications

• Background Gottlieb GJ, Ragaz A, Vogel JV, Friedman-Kien A, Rywlin AM, Weiner EA, Ackerman AB. A preliminary communication on extensively disseminated Kaposi's sarcoma in young homosexual men. Am J Dermatopathol. 1981 Summer;3(2):111-4. doi: 10.1097/00000372-198100320-00002. No abstract available.
• Background Hymes KB, Cheung T, Greene JB, Prose NS, Marcus A, Ballard H, William DC, Laubenstein LJ. Kaposi's sarcoma in homosexual men-a report of eight cases. Lancet. 1981 Sep 19;2(8247):598-600. doi: 10.1016/s0140-6736(81)92740-9.
• Background Safai B, Johnson KG, Myskowski PL, Koziner B, Yang SY, Cunningham-Rundles S, Godbold JH, Dupont B. The natural history of Kaposi's sarcoma in the acquired immunodeficiency syndrome. Ann Intern Med. 1985 Nov;103(5):744-50. doi: 10.7326/0003-4819-103-5-744.
• Background Yarchoan R, Uldrick TS. HIV-Associated Cancers and Related Diseases. N Engl J Med. 2018 Mar 15;378(11):1029-1041. doi: 10.1056/NEJMra1615896.
• Background Lacombe JM, Boue F, Grabar S, Viget N, Gazaignes S, Lascaux-Cametz AS, Pacanowski J, Partisani M, Launay O, Matheron S, Rosenthal E, Rouveix E, Tattevin P, de Truchis P, Costagliola D, Goedert JJ. Risk of Kaposi sarcoma during the first months on combination antiretroviral therapy. AIDS. 2013 Feb 20;27(4):635-43. doi: 10.1097/QAD.0b013e32835cba6c.
• Cornejo-Juarez P, Islas-Munoz B, Ramirez-Ibarguen AF, Rosales-Pedraza G, Chavez-Mazari B, Martinez-Orozco A, Volkow-Fernandez P. Bone Marrow Culture Yield for the Diagnosis of Opportunistic Diseases in Patients with AIDS and Disseminated Kaposi Sarcoma. Curr HIV Res. 2020;18(4):277-282. doi: 10.2174/1570162X18666200603145640.

Drugs

Indications