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Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

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: NCT00162097
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : August 25, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Hepatic Impairment
Intervention Drug: efavirenz containing antiretroviral regimen
Enrollment 21
Recruitment Details  
Pre-assignment Details 21 participants were enrolled in the study; 5 discontinued prior to study drug administration (1 adverse event, 1 enrollment completed, 1 screen failure, 1 no longer met study criteria and 1 withdrew consent).
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe). Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15. Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Period Title: Overall Study
Started 6 [1] 2 [1] 1 [1] 7 [2]
Completed 6 2 1 6
Not Completed 0 0 0 1
Reason Not Completed
Participant no longer met study criteria             0             0             0             1
[1]
Treated on Day 1
[2]
Treated on Day 1. One participant enrolled twice in the study and is hence counted twice
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function Total
Hide Arm/Group Description Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe). Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9. Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15. Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group Total of all reporting groups
Overall Number of Baseline Participants 6 2 1 7 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
50  (11) 51  (1) 47 49  (4) 49  (7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
< 65 years 5 2 1 7 15
>= 65 years 1 0 0 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
Female
4
  66.7%
0
   0.0%
1
 100.0%
0
   0.0%
5
  31.3%
Male
2
  33.3%
2
 100.0%
0
   0.0%
7
 100.0%
11
  68.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
Hispanic or Latino
1
  16.7%
0
   0.0%
1
 100.0%
0
   0.0%
2
  12.5%
Not Hispanic or Latino
5
  83.3%
2
 100.0%
0
   0.0%
6
  85.7%
13
  81.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   6.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
American Indian 1 0 0 0 1
Black 3 1 0 5 9
White 2 1 0 2 5
Hispanic/Latino 0 0 1 0 1
Body mass index (BMI) Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
26.3  (3.7) 24.6  (0.1) 24.0 22.8  (2.2) 24.4  (3.0)
[1]
Measure Description: BMI is defined as the individual's body weight divided by the square of his or her height.
Height Continuous  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
165.5  (11.9) 173.4  (3.7) 160.0 175.6  (7.2) 170.6  (10.0)
Weight, Continuous  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 6 participants 2 participants 1 participants 7 participants 16 participants
71.5  (7.2) 73.9  (2.9) 61.5 70.4  (9.6) 70.7  (7.9)
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax)
Hide Description Cmax was obtained directly from the concentration-time data.
Time Frame Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed per protocol.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 6
Geometric Mean (Full Range)
Unit of Measure: micrograms (mcg)/mL
5.303
(2.730 to 16.000)
8.964
(4.900 to 16.400)
6.750
(6.750 to 6.750)
6.515
(2.680 to 25.300)
2.Primary Outcome
Title Minimum Plasma Concentration (Cmin)
Hide Description Cmin was obtained directly from the concentration-time data.
Time Frame Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed per protocol.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 6
Geometric Mean (Full Range)
Unit of Measure: mcg/mL
2.599
(0.688 to 11.500)
4.885
(1.850 to 12.900)
3.780
(3.780 to 3.780)
2.405
(0.611 to 17.900)
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve Over the Dosing Interval of 24 Hours (AUC[TAU])
Hide Description The AUC(TAU), from time 0 to the time of the last measurable concentration (t), was calculated by the linear trapezoidal rule.
Time Frame Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed per protocol.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 1 1 6
Geometric Mean (Full Range)
Unit of Measure: mcg*h/mL
83.422
(29.84 to 323.06)
75.425
(75.425 to 75.425)
101.912
(101.912 to 101.912)
93.516
(36.51 to 486.43)
4.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description Tmax was obtained directly from the concentration-time data.
Time Frame Blood samples were collected at time 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose, relative to administration of PM or AM dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed per protocol.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 6
Median (Full Range)
Unit of Measure: hours
1.765
(0.98 to 6.03)
4.500
(3.00 to 6.00)
1.000
(1.00 to 1.00)
3.500
(2.00 to 6.00)
5.Secondary Outcome
Title Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs)
Hide Description An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge.
Hide Outcome Measure Data
Hide Analysis Population Description
All data from participants who signed the informed consent and enrolled in the study is included in the data set used for evaluating SAEs.
Arm/Group Title Participants With Mild Hepatic Impairment Participants With Moderate Hepatic Impairment Participants With Severe Hepatic Impairment Participants With Normal Hepatic Function Participants Not Dosed
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Participants were enrolled in the study and discontinued prior to study drug administration
Overall Number of Participants Analyzed 6 2 1 7 5
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0 0 1
Other Serious Adverse Events 0 0 0 0 1
6.Secondary Outcome
Title Number of Participants Who Experienced AEs
Hide Description AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
1 0 0 0
7.Secondary Outcome
Title Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation
Hide Description AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
0 0 0 0
8.Secondary Outcome
Title Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following hematology MA definitions specify the criteria for the data presented. Low platelet count: <0.85 x lower limit of normal (LLN) (or if pre-treatment value <LLN, then <0.85 x pre-treatment value). Low leukocytes: <0.9 x LLN (or if pre-treatment value <LLN, then <0.85 x pre-treatment value. If pre-treatment value >upper limit of normal [ULN], then <LLN). Low neutrophils+bands (absolute): <=1.500 10^3 cells/microliter (uL). Low lymphocytes (absolute): <0.750 10^3 cells/uL.
Time Frame Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 and were evaluated for these measures.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 5 2 1 7
Measure Type: Number
Unit of Measure: participants
Low platelet count 0 1 0 0
Low leukocytes 1 0 0 1
Low neutrophils+bands (absolute) 1 2 1 0
Low lymphocytes (absolute) 0 0 1 0
9.Secondary Outcome
Title Number of Participants With Serum Chemistry MAs
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following serum chemistry MA definitions specify the criteria for MAs in the data presented. High bilirubin (total): >1.1 x ULN (or if pre-treatment value >ULN, then >1.25 x pre-treatment value). High creatinine: >1.33 x pre-treatment value. Low albumin: <0.9 x LLN (or if pre-treatment value <LLN, then <0.9 x pre-treatment value). High amylase (total): >2 x pre-treatment value.
Time Frame Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis. The 'n' signifies those participants who received study drug and were evaluated for this measure, for each group respectively.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
High bilirubin (total) (n = 5, 1, 1, 7) 1 0 0 0
High creatinine (n = 5, 1, 1, 7) 0 0 0 1
Low albumin (n = 5, 1, 1, 7) 0 1 0 0
High amylase (total) (n = 5, 1, 0, 7) 0 0 0 1
10.Secondary Outcome
Title Number of Participants With Urinalysis MAs
Hide Description MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly "positive" urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+).
Time Frame Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 and were evaluated for these measures.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 5 1 1 7
Measure Type: Number
Unit of Measure: participants
White blood cells (WBCs) 1 0 0 0
Red blood cells (RBCs) 1 0 0 0
11.Secondary Outcome
Title Number of Participants With Identified Electrocardiogram (ECG) Abnormalities
Hide Description ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
3 1 0 5
12.Secondary Outcome
Title Number of Participants With Clinically Meaningful Vital Signs Measures
Hide Description Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
0 0 0 0
13.Secondary Outcome
Title Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1)
Hide Description The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator
Time Frame From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug on Day 1 were included in the analysis. Physical examination findings were not analysed at discharge.
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function
Hide Arm/Group Description:
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
Overall Number of Participants Analyzed 6 2 1 7
Measure Type: Number
Unit of Measure: participants
5 2 1 5
Time Frame [Not Specified]
Adverse Event Reporting Description One participant enrolled twice in the study in EFV600mg participants with normal hepatic function group and is hence counted twice in this group.
 
Arm/Group Title EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function Not Dosed
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function Not Dosed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function Not Dosed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/2 (0.00%)   0/1 (0.00%)   0/7 (0.00%)   1/5 (20.00%) 
Infections and infestations           
OESOPHAGEAL CANDIDIASIS  1  0/6 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
AIDS RELATED COMPLICATION  1  0/6 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Metabolism and nutrition disorders           
HYPONATRAEMIA  1  0/6 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EFV600mg Participants With Mild Hepatic Impairment EFV600mg Participants With Moderate Hepatic Impairment EFV600mg Participants With Severe Hepatic Impairment EFV600mg Participants With Normal Hepatic Function Not Dosed
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/2 (0.00%)   0/1 (0.00%)   0/7 (0.00%)   0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
OROPHARYNGEAL PAIN  1  1/6 (16.67%)  0/2 (0.00%)  0/1 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
The study was terminated early leading to a small number of participants treated and analyzed. Due to the small sample size, no conclusion could be made for participants with Child-Pugh scores B and C (moderate and severe hepatic impairment).
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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162097    
Other Study ID Numbers: AI266-917
First Submitted: September 9, 2005
First Posted: September 13, 2005
Results First Submitted: July 28, 2010
Results First Posted: August 25, 2010
Last Update Posted: September 14, 2010