| Secondary | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest | An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | Participants who received study drug and were evaluable. | Posted | | Number | | Participants | | Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG001 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG002 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. |
| | | Title | Denominators | Categories |
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| Deaths | | | | SAEs | | |
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| Secondary | Number of Participants With Abnormalities in Vital Signs | Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate. | Participants who received study drug and were evaluable. | Posted | | Number | | Participants | | Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | All Treated | All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine. |
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| Primary | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir | | Participants who received study drug and had adequate PK profiles. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG001 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG002 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. |
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| Primary | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir | | Participants who received study drug and had adequate PK profiles. | Posted | | Median | Full Range | Hours | | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG001 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG002 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. |
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| Primary | Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir | | Participants who received study drug and had adequate PK profiles. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG001 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG002 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. |
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| Secondary | Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings | ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities. | Participants who received study drug and were evaluable. | Posted | | Number | | Participants | | Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | All Treated | All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine. |
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| Secondary | Number of Participants With Abnormalities in Laboratory Test Results | PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. | Participants who received study drug and were evaluable. | Posted | | Number | | Participants | | Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely. | | | | ID | Title | Description |
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| OG000 | Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. | | OG001 | Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF. |
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