| Primary | Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 | The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC). | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | At Week 24 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
| | | Title | Denominators | Categories |
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| NC=F (n=63, 30) | | | | NC=M (n=58, 27) | | |
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| Secondary | Number of Nonresponders at Week 8 | Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL. | The first 60 participants randomized, who received at least 1 dose of study medication. | Posted | | Number | | Participants | | At Week 8 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96 | Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases. | The study terminated early, and this analysis was done only at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated. | Posted | | Number | | Participants | | At Weeks 48 and 96 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 | NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | At Week 24 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48 | | The study terminated early, and this analysis was only done at Week 48 using VR-OC for participants who reached Week 48 when the study was terminated. | Posted | | Number | | Participants | | At Week 48 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96 | | This analysis was not preformed due to early termination of the study. | Posted | | Number | | Participants | | At Week 96 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count | | All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results. | Posted | | Mean | Standard Error | cells/mm^3 | | From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation | AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | Week 1 to Week 96, continuously | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Baseline and Mean Change From Baseline in Total Cholesterol Levels | The mean change from baseline in participant fasting lipids was determined using fasting serum samples. | All randomized participants who received at least 1 dose of study medication. N=number of participants analyzed; n=number of participants with measurements for that time point. | Posted | | Mean | Standard Error | mg/dL | | From Baseline to Week 24 and Week 48 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Mean Change From Baseline in Total Bilirubin Level | | All randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Error | mg/dL | | From Baseline to Week 24 and Week 48 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Mean Change From Baseline in Electrocardiogram Findings | The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24. | All randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Error | msec | | From Baseline to Week 24 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval | Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. | All randomized participants who received at least 1 dose of study medication and were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir Cmax in 1 Dosing Interval | Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. | All randomized participants who received at least 1 dose of study medication and were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Time of Maximum Observed Plasma Concentration (Tmax) | Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Full Range | Hours | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir Tmax | Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Full Range | Hours | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir Cmin 12 Hours Postdose | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Cmin Prior to the Morning Dose | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng*h / mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir Cmin Prior to the Morning Dose | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir AUC (0-12h) in 1 Dosing Interval | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval | AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2. | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Standard Deviation | ng•h/mL | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Individual Inhibitory Quotient (IQ) | Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates. | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Geometric Mean | Full Range | Units on a Scale | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Atazanavir Terminal Elimination Half Life | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Mean | Standard Deviation | Hours | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Raltegravir Terminal Elimination Half Life | | All randomized participants who received at least 1 dose of study medication and who were evaluable. | Posted | | Mean | Standard Deviation | Hours | | At Week 2 from Baseline | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily |
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| Secondary | Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants | ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | While on treatment from Baseline through Week 96 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 | Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | While on treatment from Baseline through Week 96 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) | Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: \ | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | While on treatment from Baseline through Week 96 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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| Secondary | Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 | AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. | All randomized participants who received at least 1 dose of study medication. | Posted | | Number | | Participants | | While on treatment from Baseline through Week 96 | | | | ID | Title | Description |
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| OG000 | Atazanavir + Raltegravir | Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily | | OG001 | Atazanavir + Ritonavir + Tenofovir/Emtricitabine | Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily |
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