Development of life-threatening infection or malignancy. Development of serious HIV-related illness. Permanent discontinuation of all antiretroviral drugs. Inability to tolerate procedures or study requirements. Patient requests discontinuation of study treatment.
Principle investigator feels it is in the patient's best interest.
Subsequent cycles are initiated at a dose below the level that gave rise to the DLT during the previous cycle. Pregnancy or breast-feeding. Intercurrent illness that, in the judgment of the clinician, would significantly affect the assessment of clinical status. Use of cytotoxic agents, approved or experimental, for any reason. Recruiting USA accrual 000620.