Bilirubin* =< 2 x upper limit of normal* In the absence of Gilbert�s disease
Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN), unless elevated secondary to lymphomatous involvement of liver or biliary system, or due to other HIV medications (e.g., indinavir, tenofovir, or atazanavir); if secondary to lymphomatous involvement, an initial upper limit of total bilirubin 5 mg/dL (85.5 uM/L) should be utilized - for direct bilirubin > 1.2 mg/dL (20.5 uM/L)
Total bilirubin must be < 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert�s syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (unless due to Gilbert�s disease or disease-related hemolysis, then =< 3.0 x ULN)
Total bilirubin=< 1.5 x upper limit of normal (ULN) (if, however, the participant has Gilbert�s disease or unconjugated hyperbilirubinemia that is considered to be secondary to with atazanavir or indinavir therapy, then the total bilirubin must be =< 3 x ULN)
Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert�s syndrome, for which bilirubin =< 3 x upper limit of normal [ULN] is permitted) obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Bilirubin =< 2 x upper limit of normal (ULN) (unless documented Gilbert�s syndrome, for which Bilirubin =< 3 x upper limit of normal [ULN] is permitted); obtained within 2 weeks prior to registration
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (or =< 2.5 x ULN for patients with Gilbert�s syndrome)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert�s syndrome
Bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert�s syndrome, within 2 weeks of the first dose of study treatment
Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert�s or Meulengracht�s syndrome); the values must be obtained within 48 hours prior to randomization
Total bilirubin < 2.0 mg/dL unless due to Gilbert�s disease, hemolysis or leukemia
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert�s syndrome may have serum bilirubin > 1.5 � ULN)
Bilirubin =< 1.5 x ULN within 14 days prior to study registration; unless patient has Gilbert�s disease
Total bilirubin =< 1.5 x institutional upper limit of normal; unless due to Gilbert�s syndrome
Total bilirubin =< ULN (institutional upper limit of normal) except elevated total bilirubin < 1.5 x ULN due to Gilbert�s disease or similar syndrome involving slow conjugation of bilirubin, measured within 28 days prior to randomization
Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert�s syndrome)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.5 x ULN with Gilbert�s disease)
Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (patients with Gilbert�s syndrome may have direct bilirubin > 2.5 x ULN)
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert�s syndrome, obtained within 4 weeks prior to randomization
Total bilirubin =< 1.5 x upper limit of normal (ULN) (unless Gilbert�s syndrome or disease infiltration of the liver is present)
Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented Gilbert�s disease, who must have a total bilirubin =< 3.0 mg/dL), must be obtained within 8 weeks prior to screening for protocol therapy
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in patients with documented Gilbert�s disease, who must have a total bilirubin =< 3.0 mg/dL)
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert�s syndrome
Total bilirubin =< 1.5 x upper limit of normal (ULN); for subjects with known Gilbert�s disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =< 3.0 mg/dL
Total bilirubin =< 1.25 x institutional upper limit of normal (ULN), with the exception of < 2.9 mg/dL for patients with Gilbert�s disease
Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those with known Gilbert�s syndrome
Within 2 weeks prior to screening step registration and within 4 weeks prior to treatment step registration: Total bilirubin =< 1.5 X institutional upper limit of normal (ULN) (unless documented Gilbert�s syndrome, for which bilirubin =< 3 x institutional ULN is permitted)
Within 6 weeks prior to randomization: Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert�s disease or similar syndrome involving slow conjugation of bilirubin
PARTICIPANTS NOT ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) =< 3 x ULN for subjects with Gilbert�s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation and must have a total bilirubin less than 3.0 mg/dL, within 2 weeks prior to enrollment
PARTICIPANTS ON THE HODGKIN LYMPHOMA EXPANSION COHORT: Total bilirubin: =<1.5 � institutional upper limit of normal (ULN), or =< 3 x ULN for participants with Gilbert�s disease or with atazanavir- or indinavir-induced unconjugated hyperbilirubinemia without AST or ALT elevation, and must have a total bilirubin less than 3.0 mg/dL), within 2 weeks prior to enrollment
Total bilirubin =< 1.5 x upper limit of normal (ULN); except in case of Gilbert�s disease
Total bilirubin =< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert�s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); an exception to this may be allowed for participants with Gilbert�s syndrome with documented approval by the protocol chair
Total bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert�s syndrome may have serum bilirubin > 1.5 ULN)
Total bilirubin =< 1.5 x ULN (patients with Gilbert�s syndrome may have serum bilirubin > 1.5 x ULN)
Total bilirubin =< 1.5 x upper limit of normal (ULN), unless due to Gilbert�s syndrome or hemolysis, in which case =< 3.0 x ULN is allowed
Total bilirubin =< 1.5 x ULN unless Gilbert�s syndrome of disease infiltration of the liver is present
Total bilirubin < 1.5 X upper limit of normal (ULN); or < 3 x institutional ULN for Gilbert�s syndrome or HIV protease inhibitors; or < 5 x ULN and direct bilirubin < 0.7 mg/dL for patients on atazanavir containing HIV regimen
Total bilirubin must be =< ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert�s disease or similar syndrome involving slow conjugation of bilirubin within 28 days before randomization
Total bilirubin (=< 1.5 mg/dl) normal unless history of Gilbert�s syndrome
Total bilirubin =< 1.5 x normal institutional limits; this will not apply to patients with confirmed Gilbert�s syndrome (persistent or recurrent hyperbilirubinemia [predominantly unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician
Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN)* If elevated total bilirubin is due Gilbert�s disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN
Total bilirubin =< 2.0 mg/dL unless due to Gilbert�s syndrome, hemolysis, or ineffective hematopoiesis
Total bilirubin > 1.5 times ULN if no liver metastases or > 3 times ULN in the presence of documented Gilbert�s syndrome (unconjugated hyperbilirubinemia) or liver metastases
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN) (except patients with Gilbert�s syndrome, who can have total bilirubin < 3 mg/DL)
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (except for patients with known Gilbert�s syndrome who must have normal direct bilirubin)
Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert�s syndrome
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 30 days of day 1 of study; NOTE: patients with elevated bilirubin secondary to Gilbert�s disease are eligible to participate in the study