AIDS malignancy consortium (AMC) study 061: A phase I/PK study of sunitinib (S) with highly active antiretroviral therapy (HAART) in HIV+ patients with solid tumors.

2591 Background: Rates of non-AIDS defining cancers (NADCs) now exceed those of AIDS-defining cancers in HIV+ patients taking HAART. Treatment of NADCs may be complicated by drug-drug interactions between HAART and chemotherapy, including HAART induction or inhibition of metabolizing enzymes, especially CYP3A4. We present findings from the first of a series of studies by the AMC of new targeted therapies and HAART in HIV+ cancer pts. Methods: Pts were stratified into two arms to determine the MTD of S: (1) non-ritonavir based HAART or (2) ritonavir-based HAART. Pts in arm 1 received the standard dose of S (50mg). Arm 2 used a phase I, 3+3 dose escalation design (25, 37.5, and 50mg). S was taken daily on a 4 wk on/2 wk off cycle. PK monitoring of S and its active metabolite (S-M) were performed throughout cycle one, and normalized based on dose level, to calculate AUC-24, Cmax, and trough level. Results: Between 8/09 and 1/11, 16 patients were enrolled and completed cycle 1 (9 on arm 1, 7 on arm 2). Follow...