Sunitinib Malate in Treating HIV-Positive Patients With Cancer Undergoing Highly Active Antiretroviral Therapy

OBJECTIVES:

Primary

- To determine the safety of sunitinib malate in HIV-positive patients with cancer
undergoing highly active antiretroviral therapy (HAART) containing protease inhibitors
and/or non-nucleoside reverse transcriptase inhibitors.

- To investigate the pharmacological interactions of sunitinib malate.

Secondary

- To evaluate the efficacy of sunitinib malate in treating patients with
non-AIDS-defining cancers.

- To detect alterations in antiretroviral drug pharmacokinetics due to sunitinib malate.

- To detect alterations in immune parameters, including total leukocyte count, CD4 count,
and viral load, during treatment with sunitinib malate.

- To correlate variations in genes involved in sunitinib malate absorption, metabolism,
and elimination (e.g., CYP3A4, CYP3A5, ABCB1, and ABCG2) with drug pharmacokinetics.

- To explore the potential for pharmacological interactions between sunitinib and newer
antiretroviral agents such as integrase and CCR5 inhibitors.

OUTLINE: This is a multicenter study. Patients are stratified according to type of highly
active antiretroviral therapy (non-nucleoside reverse transcriptase inhibitor-based therapy
vs non-ritonavir protease inhibitor [PI]-based therapy vs ritonavir PI-based therapy).

Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks
in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for pharmacokinetic studies by liquid
chromatography-tandem mass spectrometry (LC-MS/MS).

After completion of study therapy, patients are followed for at least 1 month.