Phase II AIDS Malignancy Consortium trial of topical halofuginone in AIDS-related Kaposi sarcoma.

Koon HB, Fingleton B, Lee JY, Geyer JT, Cesarman E, Parise RA, Egorin MJ, Dezube BJ, Aboulafia D, Krown SE
J Acquir Immune Defic Syndr. 2011 56 (1): 64-8

PMID: 21068672 · PMCID: PMC3017346 · DOI:10.1097/QAI.0b013e3181fc0141

Using a novel blinded intrapatient vehicle control design, we conducted a phase II study of topically administered halofuginone, an angiogenesis inhibitor that inhibits collagen type-I and matrix metalloproteinases (MMPs), in patients with AIDS-related Kaposi sarcoma. Serial Kaposi sarcoma biopsies assessed treatment effects on angiogenic factors and Kaposi sarcoma herpesvirus-latency associated nuclear antigen-1 (KSHV-LANA). We observed marked heterogeneity of KSHV-LANA expression. Although the small number of subjects whose response could be evaluated precluded definitive assessment of halofuginone's efficacy, we observed a significant decrease in type-I collagen only in halofuginone-treated lesions, but no effect on MMP-2. The trial design is applicable to future studies of topical agents.

MeSH Terms (13)

Administration, Topical Adult AIDS-Related Opportunistic Infections Antineoplastic Agents Female Humans Male Middle Aged Piperidines Quinazolinones Sarcoma, Kaposi Single-Blind Method Young Adult

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