Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants

Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.

Time frame: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.

Time frame: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants

AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles.

Time frame: Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle

Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Time frame: Days 1 to 31 (discharge), continuously

Number of Participants With Marked Abnormalities in Serum Chemistry Test Results

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If \>1.25\*ULN, or if preRX\>ULN, use \>1.25\*preRX. Total and direct bilirubin: If \>1.1\*ULN or if preRX\>ULN, use \>1.25\*preRX. Creatinine: If \>1.33\*preRX. Serum glucose, fasting: If preRX\<LLN, use \<.8\*preRX or \>ULN; if preRX\>ULN, use \>2\*preRX or \<LLN. Creatinine kinase: If \>1.5\*ULN or preRX\>ULN, use \>1.5\*or preRX. Lactose dehydrogenase: If \>1.25\*ULN or preRX\>ULN, use \>1.5\*preRX.

Time frame: Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)

Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results

LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If \<.85\*LLN or \>1.15\*ULN or ULN or if preRX\<LLN, use \<0.85\*preRX or \>ULN; if preRX\>ULN, use \>1.15\*preRX or \<LLN. Lymphocytes, relative: If \<0.85\*LLN or \>1.15\*ULN, or if preRX \<LLN, use \<0.85\*preRX or \>ULN; if preRX \>ULN, use \>1.15\*preRX or \<LLN. Blood, urine: If \>= 2+, or if preRX \>=1+, use \>=2\*preRX. White blood cells, urine: If \>=2+, or if preRX \>=2+, use \>=4+. Red blood cells, urine: If \>=2+ or if preRX \>=2+, use \>=4+. Not all categories were evaluated for each arm.

Time frame: Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)

Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator

volt=voltage; LVH=left ventricular hypertrophy

Time frame: Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)

Number of Participants With Abnormalities in Vital Signs

Time frame: Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge)