Trial Outcomes & Findings for Phase IIB Pilot of Atazanavir + Raltegravir (NCT NCT00768989)

NCT ID: NCT00768989

Last Updated: 2012-02-24

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 167 participants
• Primary outcome timeframe: At Week 24 from Baseline
• Results posted on: 2012-02-24

Participant Flow

Participants were enrolled from sites in Argentina (n=21 randomized), France (n=26 randomized), and the United States (n=47 randomized).

Of 167 participants enrolled, 94 were randomized to treatment; 1 withdrew consent after randomization but prior to study dosing. Of the 73 not randomized, 5 withdrew consent, 1 lost to follow up; 1 poor/noncompliance; 61 no longer met study criteria, and 5 for other reasons. The trial was terminated early.

Participant milestones

Measure	Atazanavir + Raltegravir Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily	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
Prior to Week 24 STARTED	63	30
Prior to Week 24 COMPLETED	59	27
Prior to Week 24 NOT COMPLETED	4	3
Week 24 to Prior to Week 36 STARTED	59	27
Week 24 to Prior to Week 36 COMPLETED	51	27
Week 24 to Prior to Week 36 NOT COMPLETED	8	0
On or After Week 36 STARTED	51	27
On or After Week 36 COMPLETED	0	0
On or After Week 36 NOT COMPLETED	51	27

Reasons for withdrawal

Measure	Atazanavir + Raltegravir Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily	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
Prior to Week 24 Withdrawal by Subject	1	0
Prior to Week 24 Adverse Event	3	0
Prior to Week 24 Lost to Follow-up	0	1
Prior to Week 24 Protocol Violation	0	2
Week 24 to Prior to Week 36 Adverse Event	1	0
Week 24 to Prior to Week 36 Lack of Efficacy	6	0
Week 24 to Prior to Week 36 Withdrawal by Subject	1	0
On or After Week 36 Lack of Efficacy	1	0
On or After Week 36 Adverse Event	0	1
On or After Week 36 Lost to Follow-up	1	0
On or After Week 36 Poor Compliance	1	0
On or After Week 36 Protocol Violation	1	0
On or After Week 36 Did not attend termination visit	2	0
On or After Week 36 Sponsor Termination	45	26

Baseline Characteristics

Phase IIB Pilot of Atazanavir + Raltegravir

Baseline characteristics by cohort

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily	Total n=93 Participants Total of all reporting groups
HIV RNA Distribution at Baseline >=500,000 copies/mL	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Age Continuous	39.5 years STANDARD_DEVIATION 10.90 • n=5 Participants	41.6 years STANDARD_DEVIATION 10.87 • n=7 Participants	40.2 years STANDARD_DEVIATION 10.88 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	28 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	23 Participants n=7 Participants	77 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Mean Cluster of Differentiation 4 (CD4) Cell Count at Baseline	256.2 cells/mm^3 STANDARD_DEVIATION 116.79 • n=5 Participants	261.2 cells/mm^3 STANDARD_DEVIATION 134.93 • n=7 Participants	257.8 cells/mm^3 STANDARD_DEVIATION 122.21 • n=5 Participants
HIV RNA Level at Baseline	4.9 log10 copies/mL STANDARD_DEVIATION 0.57 • n=5 Participants	4.9 log10 copies/mL STANDARD_DEVIATION 0.66 • n=7 Participants	4.9 log10 copies/mL STANDARD_DEVIATION 0.60 • n=5 Participants
HIV RNA Distribution at Baseline < 30,000 copies/mL	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
HIV RNA Distribution at Baseline 30,000 to <100,000 copies/mL	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
HIV RNA Distribution at Baseline 100,000 to <500,000 copies/mL	26 Participants n=5 Participants	10 Participants n=7 Participants	36 Participants n=5 Participants
CD4 Distribution at Baseline < 50 cells/mm^3	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
CD4 Distribution at Baseline 50 to < 100 cells/mm^3	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
CD4 Distribution at Baseline 100 to < 200 cells/mm^3	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
CD4 Distribution at Baseline 200 to < 350 cells/mm^3	29 Participants n=5 Participants	13 Participants n=7 Participants	42 Participants n=5 Participants
CD4 Distribution at Baseline 350 to < 500 cells/mm^3	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
CD4 Distribution at Baseline >= 500 cells/mm^3	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 24 from Baseline

Population: All randomized participants who received at least 1 dose of study medication.

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).

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 NC=F (n=63, 30)	47 Participants	19 Participants
Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 NC=M (n=58, 27)	47 Participants	19 Participants
Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 VR-OC (n=52, 25)	41 Participants	19 Participants

SECONDARY outcome

Timeframe: At Week 8 from Baseline

Population: The first 60 participants randomized, who received at least 1 dose of study medication.

Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.

Outcome measures

Measure	Atazanavir + Raltegravir n=37 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=20 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Nonresponders at Week 8	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Weeks 48 and 96 from Baseline

Population: 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.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=45 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=25 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96	37 Participants	19 Participants

SECONDARY outcome

Timeframe: At Week 24 from Baseline

Population: All randomized participants who received at least 1 dose of study medication.

NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 NC=F (n= 63, 30)	52 Participants	26 Participants
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 NC=M (n=58, 27)	52 Participants	26 Participants
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 VR-OC (n=52, 25)	46 Participants	24 Participants

SECONDARY outcome

Timeframe: At Week 48 from Baseline

Population: 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.

Outcome measures

Measure	Atazanavir + Raltegravir n=45 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=25 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48	45 Participants	25 Participants

SECONDARY outcome

Timeframe: At Week 96 from Baseline

Population: This analysis was not preformed due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24

Population: All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 24 (n=55, 24)	166.0 cells/mm^3 Standard Error 16.954	127.0 cells/mm^3 Standard Error 17.788
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 2 (n=59, 26)	81.1 cells/mm^3 Standard Error 11.886	63.1 cells/mm^3 Standard Error 14.248
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 4 (n=62, 27)	82.7 cells/mm^3 Standard Error 12.238	100.1 cells/mm^3 Standard Error 19.481
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 8 (n=60, 29)	111.5 cells/mm^3 Standard Error 12.297	111.9 cells/mm^3 Standard Error 16.845
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 12 (n=62, 28)	128.6 cells/mm^3 Standard Error 13.964	129.3 cells/mm^3 Standard Error 20.460
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 16 (n=58, 27)	143.6 cells/mm^3 Standard Error 12.789	127.6 cells/mm^3 Standard Error 19.336
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count Mean change from Baseline at Week 20 (n=58, 24)	166.5 cells/mm^3 Standard Error 12.189	140.7 cells/mm^3 Standard Error 19.919

SECONDARY outcome

Timeframe: Week 1 to Week 96, continuously

Population: All randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation SAEs	7 Participants	2 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation Deaths	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation AEs leading to discontinuation	4 Participants	1 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation AEs	60 Participants	29 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation SAEs leading to discontinuation	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline to Week 24 and Week 48

Population: 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.

The mean change from baseline in participant fasting lipids was determined using fasting serum samples.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Baseline and Mean Change From Baseline in Total Cholesterol Levels Baseline (n=56, 26)	164.6 mg/dL Standard Error 3.833	169.6 mg/dL Standard Error 6.756
Baseline and Mean Change From Baseline in Total Cholesterol Levels Mean change from Baseline at Week 24 (n=51, 20)	14.7 mg/dL Standard Error 4.367	15.1 mg/dL Standard Error 6.827
Baseline and Mean Change From Baseline in Total Cholesterol Levels Mean change from Baseline at Week 48 (n=38, 20)	18.0 mg/dL Standard Error 3.040	17.1 mg/dL Standard Error 4.526

SECONDARY outcome

Timeframe: From Baseline to Week 24 and Week 48

Population: All randomized participants who received at least 1 dose of study medication.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Mean Change From Baseline in Total Bilirubin Level Mean change from Baseline at Week 24	2.15 mg/dL Standard Error 0.2032	1.71 mg/dL Standard Error 0.2234
Mean Change From Baseline in Total Bilirubin Level Mean change from Baseline at Week 48	2.08 mg/dL Standard Error 0.2176	1.52 mg/dL Standard Error 0.2206

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received at least 1 dose of study medication.

The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Mean Change From Baseline in Electrocardiogram Findings QRS Interval	8.9 msec Standard Error 1.019	3.6 msec Standard Error 1.966
Mean Change From Baseline in Electrocardiogram Findings QTc Friderica Interval	-2.7 msec Standard Error 2.001	6.0 msec Standard Error 3.760
Mean Change From Baseline in Electrocardiogram Findings PR Interval	17.6 msec Standard Error 2.101	4.9 msec Standard Error 2.248

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and were evaluable.

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval	3506.5 ng/mL Standard Deviation 1366	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and were evaluable.

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir Cmax in 1 Dosing Interval	1577.0 ng/mL Standard Deviation 2516	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)	3.0 Hours Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir Tmax	2.08 Hours Interval 0.0 to 8.0	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose	687.1 ng•h/mL Standard Deviation 402	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir Cmin 12 Hours Postdose	76.2 ng•h/mL Standard Deviation 94.5	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Cmin Prior to the Morning Dose	879.25 ng*h / mL Standard Deviation 495	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir Cmin Prior to the Morning Dose	445.42 ng•h/mL Standard Deviation 577	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval	19903.4 ng•h/mL Standard Deviation 8088	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir AUC (0-12h) in 1 Dosing Interval	6446.4 ng•h/mL Standard Deviation 6432	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval	39806.7 ng•h/mL Standard Deviation 16176	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=12 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Individual Inhibitory Quotient (IQ)	23.47 Units on a Scale Interval 12.0 to 50.1	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Atazanavir Terminal Elimination Half Life	5.0 Hours Standard Deviation 2.2	—

SECONDARY outcome

Timeframe: At Week 2 from Baseline

Population: All randomized participants who received at least 1 dose of study medication and who were evaluable.

Outcome measures

Measure	Atazanavir + Raltegravir n=13 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	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
Raltegravir Terminal Elimination Half Life	2.9 Hours Standard Deviation 2.8	—

SECONDARY outcome

Timeframe: While on treatment from Baseline through Week 96

Population: All randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants Hematocrit	1 Participants	0 Participants
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants Hemoglobin	2 Participants	0 Participants
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants Platelets	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants Prothrombin Time	12 Participants	7 Participants
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants White Blood Cells	22 Participants	14 Participants

SECONDARY outcome

Timeframe: While on treatment from Baseline through Week 96

Population: All randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Blood urea nitrogen	0 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Creatinine	3 Participants	2 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypercarbia	1 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypocarbia	15 Participants	7 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypercalcemia	2 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypocalcemia	1 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hyperchloremia	0 Participants	0 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypochloremia	1 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hyperkalemia	2 Participants	0 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypokalemia	6 Participants	5 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypernatremia	0 Participants	0 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hyponatremia	3 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hyperclycemia	8 Participants	5 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Hypoglycemia	6 Participants	4 Participants

SECONDARY outcome

Timeframe: While on treatment from Baseline through Week 96

Population: All randomized participants who received at least 1 dose of study medication.

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: <LLN-30; Gr 2: <30-20; Gr 3&4: <20.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hyponatremia	3 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hyperclycemia	8 Participants	5 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hypoglycemia	6 Participants	4 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Creatine kinase	21 Participants	7 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Albumin	3 Participants	2 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hyperkalemia	2 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hypokalemia	1 Participants	1 Participants
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) Hypernatremia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: While on treatment from Baseline through Week 96

Population: All randomized participants who received at least 1 dose of study medication.

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.

Outcome measures

Measure	Atazanavir + Raltegravir n=63 Participants Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=30 Participants Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Total Bilirubin	62 Participants	28 Participants
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 AST/SGOT	11 Participants	8 Participants
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 ALT/ SGPT	10 Participants	8 Participants
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Lipase	11 Participants	13 Participants
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Proteinurea	14 Participants	11 Participants
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Creatine kinase	21 Participants	7 Participants

Adverse Events

Atazanavir + Ritonavir + Tenofovir/Emtricitabine

Serious events: 7 serious events

Other events: 58 other events

Deaths: 0 deaths

Atazanavir + Raltegravir

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=63 participants at risk Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily	Atazanavir + Raltegravir n=30 participants at risk Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Injury, poisoning and procedural complications BURNS FIRST DEGREE	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Cardiac disorders ATRIAL FLUTTER	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KAPOSI'S SARCOMA	0.00% 0/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Infections and infestations MALARIA	0.00% 0/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Injury, poisoning and procedural complications OVERDOSE	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Psychiatric disorders SUICIDE ATTEMPT	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TESTIS CANCER	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Psychiatric disorders DEPRESSION	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Injury, poisoning and procedural complications GUN SHOT WOUND	1.6% 1/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96

Other adverse events

Measure	Atazanavir + Ritonavir + Tenofovir/Emtricitabine n=63 participants at risk Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily	Atazanavir + Raltegravir n=30 participants at risk Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	3.2% 2/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Eye disorders OCULAR ICTERUS	23.8% 15/63 • While on treatment from Baseline through Week 96	13.3% 4/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders ABDOMINAL PAIN	6.3% 4/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.8% 3/63 • While on treatment from Baseline through Week 96	16.7% 5/30 • While on treatment from Baseline through Week 96
General disorders ASTHENIA	3.2% 2/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations BRONCHITIS	14.3% 9/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
General disorders FATIGUE	6.3% 4/63 • While on treatment from Baseline through Week 96	16.7% 5/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders HAEMORRHOIDS	7.9% 5/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Infections and infestations HERPES ZOSTER	6.3% 4/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations TOOTH INFECTION	6.3% 4/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Investigations BILIRUBIN CONJUGATED INCREASED	15.9% 10/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Investigations BLOOD BILIRUBIN INCREASED	17.5% 11/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Infections and infestations NASOPHARYNGITIS	6.3% 4/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	4.8% 3/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations SINUSITIS	7.9% 5/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders VOMITING	4.8% 3/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations ACARODERMATITIS	0.00% 0/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	9.5% 6/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Musculoskeletal and connective tissue disorders BACK PAIN	6.3% 4/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders DIARRHOEA	12.7% 8/63 • While on treatment from Baseline through Week 96	16.7% 5/30 • While on treatment from Baseline through Week 96
Nervous system disorders HEADACHE	17.5% 11/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Investigations ALANINE AMINOTRANSFERASE INCREASED	6.3% 4/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	12.7% 8/63 • While on treatment from Baseline through Week 96	13.3% 4/30 • While on treatment from Baseline through Week 96
Psychiatric disorders INSOMNIA	1.6% 1/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders NAUSEA	4.8% 3/63 • While on treatment from Baseline through Week 96	23.3% 7/30 • While on treatment from Baseline through Week 96
Nervous system disorders PARAESTHESIA	1.6% 1/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Musculoskeletal and connective tissue disorders MYALGIA	1.6% 1/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Skin and subcutaneous tissue disorders PRURITUS	6.3% 4/63 • While on treatment from Baseline through Week 96	10.0% 3/30 • While on treatment from Baseline through Week 96
Respiratory, thoracic and mediastinal disorders COUGH	9.5% 6/63 • While on treatment from Baseline through Week 96	26.7% 8/30 • While on treatment from Baseline through Week 96
Infections and infestations INFLUENZA	3.2% 2/63 • While on treatment from Baseline through Week 96	13.3% 4/30 • While on treatment from Baseline through Week 96
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	1.6% 1/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations SYPHILIS	6.3% 4/63 • While on treatment from Baseline through Week 96	0.00% 0/30 • While on treatment from Baseline through Week 96
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.5% 6/63 • While on treatment from Baseline through Week 96	20.0% 6/30 • While on treatment from Baseline through Week 96
Eye disorders CONJUNCTIVITIS	0.00% 0/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Gastrointestinal disorders FLATULENCE	1.6% 1/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
Infections and infestations GENITAL HERPES	6.3% 4/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Hepatobiliary disorders JAUNDICE	23.8% 15/63 • While on treatment from Baseline through Week 96	6.7% 2/30 • While on treatment from Baseline through Week 96
General disorders PYREXIA	6.3% 4/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96
Skin and subcutaneous tissue disorders RASH	12.7% 8/63 • While on treatment from Baseline through Week 96	3.3% 1/30 • While on treatment from Baseline through Week 96

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
• Publication restrictions are in place

Restriction type: OTHER