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Phase IIB Pilot of Atazanavir + Raltegravir (SPARTAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768989
Recruitment Status : Terminated (Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.)
First Posted : October 8, 2008
Results First Posted : January 16, 2012
Last Update Posted : February 24, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: Atazanavir
Drug: Raltegravir
Drug: Ritonavir
Drug: Tenofovir/Emtricitabine
Enrollment 167
Recruitment Details Participants were enrolled from sites in Argentina (n=21 randomized), France (n=26 randomized), and the United States (n=47 randomized).
Pre-assignment Details 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.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Period Title: Prior to Week 24
Started 63 30
Completed 59 27
Not Completed 4 3
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             3             0
Lost to Follow-up             0             1
Protocol Violation             0             2
Period Title: Week 24 to Prior to Week 36
Started 59 27
Completed 51 27
Not Completed 8 0
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             6             0
Withdrawal by Subject             1             0
Period Title: On or After Week 36
Started 51 27
Completed 0 0
Not Completed 51 27
Reason Not Completed
Lack of Efficacy             1             0
Adverse Event             0             1
Lost to Follow-up             1             0
Poor Compliance             1             0
Protocol Violation             1             0
Did not attend termination visit             2             0
Sponsor Termination             45             26
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine Total
Hide Arm/Group Description Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily Total of all reporting groups
Overall Number of Baseline Participants 63 30 93
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 30 participants 93 participants
39.5  (10.90) 41.6  (10.87) 40.2  (10.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 30 participants 93 participants
Female
8
  12.7%
2
   6.7%
10
  10.8%
Male
55
  87.3%
28
  93.3%
83
  89.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 30 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.3%
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  12.7%
6
  20.0%
14
  15.1%
White
54
  85.7%
23
  76.7%
77
  82.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.6%
0
   0.0%
1
   1.1%
HIV RNA Level at Baseline  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 63 participants 30 participants 93 participants
4.9  (0.57) 4.9  (0.66) 4.9  (0.60)
HIV RNA Distribution at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 30 participants 93 participants
< 30,000 copies/mL 14 7 21
30,000 to <100,000 copies/mL 15 10 25
100,000 to <500,000 copies/mL 26 10 36
>=500,000 copies/mL 8 3 11
Mean Cluster of Differentiation 4 (CD4) Cell Count at Baseline  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 63 participants 30 participants 93 participants
256.2  (116.79) 261.2  (134.93) 257.8  (122.21)
CD4 Distribution at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 30 participants 93 participants
< 50 cells/mm^3 5 4 9
50 to < 100 cells/mm^3 1 1 2
100 to < 200 cells/mm^3 13 3 16
200 to < 350 cells/mm^3 29 13 42
350 to < 500 cells/mm^3 14 9 23
>= 500 cells/mm^3 1 0 1
1.Primary Outcome
Title Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
Hide Description 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).
Time Frame At Week 24 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
NC=F (n=63, 30) 47 19
NC=M (n=58, 27) 47 19
VR-OC (n=52, 25) 41 19
2.Secondary Outcome
Title Number of Nonresponders at Week 8
Hide Description Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.
Time Frame At Week 8 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The first 60 participants randomized, who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 37 20
Measure Type: Number
Unit of Measure: Participants
0 1
3.Secondary Outcome
Title Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
Hide Description 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.
Time Frame At Weeks 48 and 96 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 45 25
Measure Type: Number
Unit of Measure: Participants
37 19
4.Secondary Outcome
Title Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
Hide Description NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed
Time Frame At Week 24 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
NC=F (n= 63, 30) 52 26
NC=M (n=58, 27) 52 26
VR-OC (n=52, 25) 46 24
5.Secondary Outcome
Title Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
Hide Description [Not Specified]
Time Frame At Week 48 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 45 25
Measure Type: Number
Unit of Measure: Participants
45 25
6.Secondary Outcome
Title Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96
Hide Description [Not Specified]
Time Frame At Week 96 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was not preformed due to early termination of the study.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
Hide Description [Not Specified]
Time Frame From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and had baseline and timepoint results.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Mean (Standard Error)
Unit of Measure: cells/mm^3
Mean change from Baseline at Week 2 (n=59, 26) 81.1  (11.886) 63.1  (14.248)
Mean change from Baseline at Week 4 (n=62, 27) 82.7  (12.238) 100.1  (19.481)
Mean change from Baseline at Week 8 (n=60, 29) 111.5  (12.297) 111.9  (16.845)
Mean change from Baseline at Week 12 (n=62, 28) 128.6  (13.964) 129.3  (20.460)
Mean change from Baseline at Week 16 (n=58, 27) 143.6  (12.789) 127.6  (19.336)
Mean change from Baseline at Week 20 (n=58, 24) 166.5  (12.189) 140.7  (19.919)
Mean change from Baseline at Week 24 (n=55, 24) 166.0  (16.954) 127.0  (17.788)
8.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation
Hide Description 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.
Time Frame Week 1 to Week 96, continuously
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
AEs 60 29
SAEs 7 2
Deaths 0 0
AEs leading to discontinuation 4 1
SAEs leading to discontinuation 1 0
9.Secondary Outcome
Title Baseline and Mean Change From Baseline in Total Cholesterol Levels
Hide Description The mean change from baseline in participant fasting lipids was determined using fasting serum samples.
Time Frame From Baseline to Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Mean (Standard Error)
Unit of Measure: mg/dL
Baseline (n=56, 26) 164.6  (3.833) 169.6  (6.756)
Mean change from Baseline at Week 24 (n=51, 20) 14.7  (4.367) 15.1  (6.827)
Mean change from Baseline at Week 48 (n=38, 20) 18.0  (3.040) 17.1  (4.526)
10.Secondary Outcome
Title Mean Change From Baseline in Total Bilirubin Level
Hide Description [Not Specified]
Time Frame From Baseline to Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Mean (Standard Error)
Unit of Measure: mg/dL
Mean change from Baseline at Week 24 2.15  (0.2032) 1.71  (0.2234)
Mean change from Baseline at Week 48 2.08  (0.2176) 1.52  (0.2206)
11.Secondary Outcome
Title Mean Change From Baseline in Electrocardiogram Findings
Hide Description The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Mean (Standard Error)
Unit of Measure: msec
QRS Interval 8.9  (1.019) 3.6  (1.966)
QTc Friderica Interval -2.7  (2.001) 6.0  (3.760)
PR Interval 17.6  (2.101) 4.9  (2.248)
12.Secondary Outcome
Title Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
Hide Description Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
3506.5  (1366)
13.Secondary Outcome
Title Raltegravir Cmax in 1 Dosing Interval
Hide Description Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
1577.0  (2516)
14.Secondary Outcome
Title Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
Hide Description Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Full Range)
Unit of Measure: Hours
3.0
(2.0 to 4.0)
15.Secondary Outcome
Title Raltegravir Tmax
Hide Description Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Full Range)
Unit of Measure: Hours
2.08
(0.0 to 8.0)
16.Secondary Outcome
Title Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
687.1  (402)
17.Secondary Outcome
Title Raltegravir Cmin 12 Hours Postdose
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
76.2  (94.5)
18.Secondary Outcome
Title Atazanavir Cmin Prior to the Morning Dose
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng*h / mL
879.25  (495)
19.Secondary Outcome
Title Raltegravir Cmin Prior to the Morning Dose
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
445.42  (577)
20.Secondary Outcome
Title Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
19903.4  (8088)
21.Secondary Outcome
Title Raltegravir AUC (0-12h) in 1 Dosing Interval
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
6446.4  (6432)
22.Secondary Outcome
Title Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval
Hide Description AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Geometric Mean (Standard Deviation)
Unit of Measure: ng•h/mL
39806.7  (16176)
23.Secondary Outcome
Title Atazanavir Individual Inhibitory Quotient (IQ)
Hide Description 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.
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 12
Geometric Mean (Full Range)
Unit of Measure: Units on a Scale
23.47
(12.0 to 50.1)
24.Secondary Outcome
Title Atazanavir Terminal Elimination Half Life
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Hours
5.0  (2.2)
25.Secondary Outcome
Title Raltegravir Terminal Elimination Half Life
Hide Description [Not Specified]
Time Frame At Week 2 from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication and who were evaluable.
Arm/Group Title Atazanavir + Raltegravir
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Hours
2.9  (2.8)
26.Secondary Outcome
Title Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
Hide Description 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.
Time Frame While on treatment from Baseline through Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
Hematocrit 1 0
Hemoglobin 2 0
Platelets 1 1
Prothrombin Time 12 7
White Blood Cells 22 14
27.Secondary Outcome
Title Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
Hide Description 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.
Time Frame While on treatment from Baseline through Week 96
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Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
Blood urea nitrogen 0 1
Creatinine 3 2
Hypercarbia 1 1
Hypocarbia 15 7
Hypercalcemia 2 1
Hypocalcemia 1 1
Hyperchloremia 0 0
Hypochloremia 1 1
Hyperkalemia 2 0
Hypokalemia 6 5
Hypernatremia 0 0
Hyponatremia 3 1
Hyperclycemia 8 5
Hypoglycemia 6 4
28.Secondary Outcome
Title Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)
Hide Description 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.
Time Frame While on treatment from Baseline through Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
Hyperkalemia 2 1
Hypokalemia 1 1
Hypernatremia 0 0
Hyponatremia 3 1
Hyperclycemia 8 5
Hypoglycemia 6 4
Creatine kinase 21 7
Albumin 3 2
29.Secondary Outcome
Title Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
Hide Description 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.
Time Frame While on treatment from Baseline through Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study medication.
Arm/Group Title Atazanavir + Raltegravir Atazanavir + Ritonavir + Tenofovir/Emtricitabine
Hide Arm/Group Description:
Atazanavir, 300 mg twice daily, plus Raltegravir, 400 mg twice daily
Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/emtricitabine, 300 mg/200 mg once daily
Overall Number of Participants Analyzed 63 30
Measure Type: Number
Unit of Measure: Participants
Total Bilirubin 62 28
AST/SGOT 11 8
ALT/ SGPT 10 8
Lipase 11 13
Proteinurea 14 11
Creatine kinase 21 7
Time Frame While on treatment from Baseline through Week 96
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir + Raltegravir
Hide Arm/Group Description Atazanavir, 300 mg once daily, plus Ritonavir, 100 mg once daily, plus fixed-dose Tenofovir/Emtricitabine, 300 mg/200 mg once daily Atazanavir 300 mg twice daily plus Raltegravir 400 mg twice daily
All-Cause Mortality
Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   7/63 (11.11%)   2/30 (6.67%) 
Cardiac disorders     
ATRIAL FLUTTER  1  1/63 (1.59%)  0/30 (0.00%) 
Infections and infestations     
MALARIA  1  0/63 (0.00%)  1/30 (3.33%) 
Injury, poisoning and procedural complications     
BURNS FIRST DEGREE  1  1/63 (1.59%)  0/30 (0.00%) 
OVERDOSE  1  1/63 (1.59%)  0/30 (0.00%) 
GUN SHOT WOUND  1  1/63 (1.59%)  0/30 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-CELL LYMPHOMA  1  1/63 (1.59%)  0/30 (0.00%) 
KAPOSI'S SARCOMA  1  0/63 (0.00%)  1/30 (3.33%) 
TESTIS CANCER  1  1/63 (1.59%)  0/30 (0.00%) 
Psychiatric disorders     
SUICIDE ATTEMPT  1  1/63 (1.59%)  0/30 (0.00%) 
DEPRESSION  1  1/63 (1.59%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atazanavir + Ritonavir + Tenofovir/Emtricitabine Atazanavir + Raltegravir
Affected / at Risk (%) Affected / at Risk (%)
Total   58/63 (92.06%)   27/30 (90.00%) 
Eye disorders     
OCULAR ICTERUS  1  15/63 (23.81%)  4/30 (13.33%) 
CONJUNCTIVITIS  1  0/63 (0.00%)  2/30 (6.67%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  4/63 (6.35%)  0/30 (0.00%) 
HAEMORRHOIDS  1  5/63 (7.94%)  0/30 (0.00%) 
VOMITING  1  3/63 (4.76%)  2/30 (6.67%) 
DIARRHOEA  1  8/63 (12.70%)  5/30 (16.67%) 
NAUSEA  1  3/63 (4.76%)  7/30 (23.33%) 
FLATULENCE  1  1/63 (1.59%)  2/30 (6.67%) 
General disorders     
ASTHENIA  1  2/63 (3.17%)  2/30 (6.67%) 
FATIGUE  1  4/63 (6.35%)  5/30 (16.67%) 
PYREXIA  1  4/63 (6.35%)  1/30 (3.33%) 
Hepatobiliary disorders     
JAUNDICE  1  15/63 (23.81%)  2/30 (6.67%) 
Infections and infestations     
BRONCHITIS  1  9/63 (14.29%)  3/30 (10.00%) 
HERPES ZOSTER  1  4/63 (6.35%)  2/30 (6.67%) 
TOOTH INFECTION  1  4/63 (6.35%)  2/30 (6.67%) 
NASOPHARYNGITIS  1  4/63 (6.35%)  1/30 (3.33%) 
SINUSITIS  1  5/63 (7.94%)  0/30 (0.00%) 
ACARODERMATITIS  1  0/63 (0.00%)  2/30 (6.67%) 
INFLUENZA  1  2/63 (3.17%)  4/30 (13.33%) 
SYPHILIS  1  4/63 (6.35%)  0/30 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  6/63 (9.52%)  6/30 (20.00%) 
GENITAL HERPES  1  4/63 (6.35%)  1/30 (3.33%) 
Investigations     
BILIRUBIN CONJUGATED INCREASED  1  10/63 (15.87%)  2/30 (6.67%) 
BLOOD BILIRUBIN INCREASED  1  11/63 (17.46%)  3/30 (10.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  6/63 (9.52%)  1/30 (3.33%) 
ALANINE AMINOTRANSFERASE INCREASED  1  4/63 (6.35%)  1/30 (3.33%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  8/63 (12.70%)  4/30 (13.33%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  3/63 (4.76%)  5/30 (16.67%) 
BACK PAIN  1  4/63 (6.35%)  3/30 (10.00%) 
MUSCLE SPASMS  1  0/63 (0.00%)  2/30 (6.67%) 
MYALGIA  1  1/63 (1.59%)  3/30 (10.00%) 
Nervous system disorders     
HEADACHE  1  11/63 (17.46%)  3/30 (10.00%) 
PARAESTHESIA  1  1/63 (1.59%)  2/30 (6.67%) 
Psychiatric disorders     
INSOMNIA  1  1/63 (1.59%)  3/30 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
NASAL CONGESTION  1  2/63 (3.17%)  2/30 (6.67%) 
OROPHARYNGEAL PAIN  1  3/63 (4.76%)  2/30 (6.67%) 
COUGH  1  6/63 (9.52%)  8/30 (26.67%) 
PRODUCTIVE COUGH  1  1/63 (1.59%)  2/30 (6.67%) 
Skin and subcutaneous tissue disorders     
PRURITUS  1  4/63 (6.35%)  3/30 (10.00%) 
RASH  1  8/63 (12.70%)  1/30 (3.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00768989    
Other Study ID Numbers: AI424-376
First Submitted: October 6, 2008
First Posted: October 8, 2008
Results First Submitted: October 19, 2011
Results First Posted: January 16, 2012
Last Update Posted: February 24, 2012