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Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

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ClinicalTrials.gov Identifier: NCT00376935
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : January 30, 2012
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Palifermin
Drug: Palifermin placebo
Enrollment 99
Recruitment Details Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.
Pre-assignment Details All randomized participants got at least one injection on each of three consecutive days.
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Period Title: Overall Study
Started 25 25 25 24
Completed 25 25 25 24
Not Completed 0 0 0 0
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg) Total
Hide Arm/Group Description Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 24 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
47
(42 to 50)
49
(43 to 54)
45
(39 to 54)
50
(46 to 57)
49
(42 to 55)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
Between 18 and 29 years 0 0 1 0 1
Between 30 and 39 years 4 1 6 2 13
Between 40 and 49 years 13 12 8 9 42
Between 50 and 59 years 4 8 7 8 27
Over 60 years 4 4 3 5 16
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
Female
3
  12.0%
2
   8.0%
3
  12.0%
1
   4.2%
9
   9.1%
Male
22
  88.0%
23
  92.0%
22
  88.0%
23
  95.8%
90
  90.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
White Non-Hispanic 15 13 12 12 52
Black Non-Hispanic 6 9 4 6 25
Hispanic (Regardless of Race) 3 3 8 6 20
Asian, Pacific Islander 1 0 0 0 1
Missing/ Unknown 0 0 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
25 25 25 24 99
IV drug use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
Never 20 22 19 20 81
Previously 5 3 6 4 18
CD4 count  
Median (Inter-Quartile Range)
Unit of measure:  Cell/mm^3
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
147
(110 to 180)
155
(126 to 194)
156
(116 to 197)
152
(112 to 192)
153
(116 to 194)
CD8 count  
Median (Inter-Quartile Range)
Unit of measure:  Cell/mm^3
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
638
(394 to 887)
615
(464 to 722)
716
(575 to 999)
761
(502 to 1099)
665
(467 to 954)
HIV-1 RNA Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 24 participants 99 participants
< 50 copies/mL 22 22 23 24 91
= 52 copies/mL 1 0 0 0 1
= 77 copies/mL 1 0 0 0 1
= 81 copies/mL 1 0 0 0 1
= 84 copies/mL 0 0 1 0 1
= 88 copies/mL 0 1 0 0 1
= 97 copies/mL 0 1 0 0 1
= 69440 copies/mL 0 1 0 0 1
Missing 0 0 1 0 1
1.Primary Outcome
Title Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)
Hide Description Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.
Time Frame Pre-entry, entry, study week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat.
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
15
(-16 to 23)
11
(2 to 32)
12
(-2 to 25)
8
(-13 to 35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Palifermin Placebo, Palifermin (20 mcg/kg)
Comments The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1996
Comments P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.
Method of Estimation Estimation Parameter Shift parameter
Estimated Value -9
Confidence Interval (1-Sided) 98.4%
14
Estimation Comments The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Palifermin Placebo, Palifermin (40 mcg/kg)
Comments The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3135
Comments P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.
Method of Estimation Estimation Parameter Shift parameter
Estimated Value -4
Confidence Interval (1-Sided) 98.4%
17
Estimation Comments The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Palifermin Placebo, Palifermin (60 mcg/kg)
Comments The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3662
Comments P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.
Method Wilcoxon (Mann-Whitney)
Comments One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.
Method of Estimation Estimation Parameter Shift parameter
Estimated Value -4
Confidence Interval (1-Sided) 98.4%
22
Estimation Comments The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.
2.Secondary Outcome
Title Qualitative Hepatitis C Virus RNA
Hide Description [Not Specified]
Time Frame At study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Measure Type: Number
Unit of Measure: participants
# of participants who had positive HCV results 4 2 1 5
# of participants who had negative HCV results 21 22 24 19
# of missing 0 1 0 0
3.Secondary Outcome
Title Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24
Hide Description Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.
Time Frame From randomization to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Measure Type: Number
Unit of Measure: participants
2 4 2 1
4.Secondary Outcome
Title Change in Naive CD4+ Cell Counts From Randomization
Hide Description [Not Specified]
Time Frame randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Day 2 (N=24, 24, 22, 22)
-2
(-5 to 2)
-2
(-10 to 3)
-1
(-4 to 2)
-2
(-6 to 1)
Week 1 (N=24, 25, 25, 24)
0
(-3 to 4)
-2
(-6 to 2)
-1
(-7 to 2)
-1
(-4 to 2)
Week 2 (N=23, 22, 24, 23)
-1
(-8 to 4)
-1
(-5 to 2)
-1
(-4 to 3)
0
(-7 to 3)
Week 4 (N=21, 24, 19, 23)
0
(-2 to 4)
-2
(-4 to 1)
1
(-4 to 3)
0
(-3 to 5)
Week 8 (N=24, 25, 21, 23)
3
(-2 to 7)
0
(-6 to 3)
1
(-3 to 5)
2
(-1 to 7)
Week 12 (N=23, 23, 21, 23)
1
(-6 to 5)
1
(-7 to 4)
1
(-3 to 5)
0
(-6 to 5)
Week 24 (N=23, 20, 22, 23)
1
(-1 to 10)
-1
(-7 to 4)
2
(-4 to 8)
1
(-4 to 7)
5.Secondary Outcome
Title Change in CT Thymic Index From Randomization
Hide Description CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.
Time Frame randomization, study week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had CT thymus evaluations at both randomization and study week 12.
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 22 22 22 22
Measure Type: Number
Unit of Measure: participants
two-sizes-smaller thymus at week 12 1 0 1 0
one-size-smaller thymus at week 12 3 6 3 3
unchanged thymus from randomization to week 12 11 12 13 13
one-size-larger thymus at week 12 7 4 4 6
two-sizes-larger thymus at week 12 0 0 1 0
6.Secondary Outcome
Title Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Hide Description [Not Specified]
Time Frame randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Day 2 (N=25, 25, 25, 24)
-4
(-15 to 22)
2
(-13 to 15)
-12
(-28 to 1)
-5
(-21 to 16)
Week 1 (N=25, 25, 25, 24)
1
(-10 to 7)
-12
(-31 to 15)
-9
(-33 to 12)
6
(-27 to 22)
Week 2 (N=24, 24, 24, 24)
-1
(-10 to 37)
1
(-29 to 9)
14
(-3 to 21)
2
(-20 to 26)
Week 4 (N=23, 24, 23, 23)
6
(-17 to 25)
1
(-17 to 9)
16
(-15 to 29)
2
(-35 to 28)
Week 8 (N=25, 25, 24, 24)
10
(-14 to 26)
2
(-15 to 20)
20
(-5 to 39)
9
(-8 to 32)
Week 12 (N=24, 23, 23, 24)
14
(-17 to 27)
11
(1 to 32)
12
(-6 to 38)
8
(-13 to 35)
Week 24 (N=25, 23, 25, 24)
14
(-10 to 26)
8
(-13 to 34)
14
(1 to 50)
15
(0 to 46)
7.Secondary Outcome
Title Grade 3 or 4 Lab Toxicities From Randomization to Week 24
Hide Description Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.
Time Frame From randomization to study week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Measure Type: Number
Unit of Measure: participants
4 5 4 6
8.Secondary Outcome
Title Number of Death From Randomization to Week 24
Hide Description Number of subjects died.
Time Frame From randomization to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palifermin Placebo Palifermin (20 mcg/kg) Palifermin (40 mcg/kg) Palifermin (60 mcg/kg)
Hide Arm/Group Description:
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
Overall Number of Participants Analyzed 25 25 25 24
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Palifermin Placebo Palifermin (20 Mcg/kg) Palifermin (40 Mcg/kg) Palifermin (60 Mcg/kg)
Hide Arm/Group Description Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3. Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
All-Cause Mortality
Palifermin Placebo Palifermin (20 Mcg/kg) Palifermin (40 Mcg/kg) Palifermin (60 Mcg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Palifermin Placebo Palifermin (20 Mcg/kg) Palifermin (40 Mcg/kg) Palifermin (60 Mcg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   1/25 (4.00%)   1/25 (4.00%)   0/24 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  0/24 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Laryngeal cancer  1  0/25 (0.00%)  1/25 (4.00%)  0/25 (0.00%)  0/24 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Palifermin Placebo Palifermin (20 Mcg/kg) Palifermin (40 Mcg/kg) Palifermin (60 Mcg/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/25 (100.00%)   24/25 (96.00%)   25/25 (100.00%)   24/24 (100.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  1/25 (4.00%)  0/25 (0.00%)  0/25 (0.00%)  2/24 (8.33%) 
Cardiac disorders         
Palpitations  1  1/25 (4.00%)  0/25 (0.00%)  2/25 (8.00%)  0/24 (0.00%) 
Eye disorders         
Eye pruritus  1  1/25 (4.00%)  0/25 (0.00%)  3/25 (12.00%)  1/24 (4.17%) 
Ocular hyperaemia  1  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  0/24 (0.00%) 
Vision blurred  1  2/25 (8.00%)  0/25 (0.00%)  0/25 (0.00%)  1/24 (4.17%) 
Gastrointestinal disorders         
Abdominal pain  1  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  2/24 (8.33%) 
Constipation  1  0/25 (0.00%)  2/25 (8.00%)  1/25 (4.00%)  1/24 (4.17%) 
Diarrhoea  1  3/25 (12.00%)  5/25 (20.00%)  5/25 (20.00%)  2/24 (8.33%) 
Dry mouth  1  2/25 (8.00%)  0/25 (0.00%)  3/25 (12.00%)  2/24 (8.33%) 
Dyspepsia  1  1/25 (4.00%)  1/25 (4.00%)  2/25 (8.00%)  0/24 (0.00%) 
Hypoaesthesia oral  1  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  2/24 (8.33%) 
Nausea  1  1/25 (4.00%)  3/25 (12.00%)  1/25 (4.00%)  2/24 (8.33%) 
Paraesthesia oral  1  1/25 (4.00%)  0/25 (0.00%)  3/25 (12.00%)  3/24 (12.50%) 
Tongue discolouration  1  0/25 (0.00%)  1/25 (4.00%)  3/25 (12.00%)  2/24 (8.33%) 
Tongue disorder  1  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  2/24 (8.33%) 
Vomiting  1  1/25 (4.00%)  5/25 (20.00%)  0/25 (0.00%)  1/24 (4.17%) 
General disorders         
Chest pain  1  1/25 (4.00%)  3/25 (12.00%)  0/25 (0.00%)  0/24 (0.00%) 
Chills  1  0/25 (0.00%)  3/25 (12.00%)  0/25 (0.00%)  0/24 (0.00%) 
Fatigue  1  3/25 (12.00%)  5/25 (20.00%)  2/25 (8.00%)  3/24 (12.50%) 
Oedema peripheral  1  1/25 (4.00%)  1/25 (4.00%)  2/25 (8.00%)  0/24 (0.00%) 
Pyrexia  1  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  1/24 (4.17%) 
Infections and infestations         
Upper respiratory tract infection  1  2/25 (8.00%)  1/25 (4.00%)  1/25 (4.00%)  1/24 (4.17%) 
Investigations         
Alanine aminotransferase increased  1  4/25 (16.00%)  4/25 (16.00%)  3/25 (12.00%)  3/24 (12.50%) 
Aspartate aminotransferase increased  1  7/25 (28.00%)  8/25 (32.00%)  3/25 (12.00%)  5/24 (20.83%) 
Blood albumin  1  1/25 (4.00%)  2/25 (8.00%)  3/25 (12.00%)  1/24 (4.17%) 
Blood alkaline phosphatase increased  1  1/25 (4.00%)  3/25 (12.00%)  4/25 (16.00%)  3/24 (12.50%) 
Blood bicarbonate  1  4/25 (16.00%)  4/25 (16.00%)  2/25 (8.00%)  2/24 (8.33%) 
Blood bilirubin increased  1  10/25 (40.00%)  6/25 (24.00%)  6/25 (24.00%)  7/24 (29.17%) 
Blood calcium decreased  1  4/25 (16.00%)  4/25 (16.00%)  0/25 (0.00%)  2/24 (8.33%) 
Blood cholesterol abnormal  1  2/25 (8.00%)  2/25 (8.00%)  0/25 (0.00%)  2/24 (8.33%) 
Blood creatinine increased  1  6/25 (24.00%)  1/25 (4.00%)  4/25 (16.00%)  4/24 (16.67%) 
Blood glucose abnormal  1  3/25 (12.00%)  3/25 (12.00%)  3/25 (12.00%)  4/24 (16.67%) 
Blood glucose decreased  1  3/25 (12.00%)  5/25 (20.00%)  3/25 (12.00%)  7/24 (29.17%) 
Blood glucose increased  1  9/25 (36.00%)  13/25 (52.00%)  16/25 (64.00%)  16/24 (66.67%) 
Blood phosphorus decreased  1  2/25 (8.00%)  3/25 (12.00%)  1/25 (4.00%)  1/24 (4.17%) 
Blood potassium decreased  1  2/25 (8.00%)  5/25 (20.00%)  4/25 (16.00%)  4/24 (16.67%) 
Blood potassium increased  1  1/25 (4.00%)  1/25 (4.00%)  2/25 (8.00%)  0/24 (0.00%) 
Blood sodium decreased  1  5/25 (20.00%)  7/25 (28.00%)  7/25 (28.00%)  5/24 (20.83%) 
Blood sodium increased  1  1/25 (4.00%)  3/25 (12.00%)  1/25 (4.00%)  0/24 (0.00%) 
Carbon dioxide  1  0/25 (0.00%)  1/25 (4.00%)  2/25 (8.00%)  3/24 (12.50%) 
Carbon dioxide abnormal  1  2/25 (8.00%)  4/25 (16.00%)  2/25 (8.00%)  2/24 (8.33%) 
Lipase increased  1  1/25 (4.00%)  2/25 (8.00%)  3/25 (12.00%)  2/24 (8.33%) 
Neutrophil count decreased  1  4/25 (16.00%)  2/25 (8.00%)  4/25 (16.00%)  1/24 (4.17%) 
Platelet count decreased  1  5/25 (20.00%)  5/25 (20.00%)  5/25 (20.00%)  1/24 (4.17%) 
White blood cell count decreased  1  3/25 (12.00%)  1/25 (4.00%)  3/25 (12.00%)  2/24 (8.33%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/25 (4.00%)  1/25 (4.00%)  2/25 (8.00%)  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  3/25 (12.00%)  3/25 (12.00%)  1/25 (4.00%)  0/24 (0.00%) 
Back pain  1  1/25 (4.00%)  0/25 (0.00%)  1/25 (4.00%)  2/24 (8.33%) 
Myalgia  1  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/24 (0.00%) 
Neck pain  1  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/24 (0.00%) 
Pain in extremity  1  3/25 (12.00%)  4/25 (16.00%)  0/25 (0.00%)  0/24 (0.00%) 
Nervous system disorders         
Dizziness  1  1/25 (4.00%)  2/25 (8.00%)  1/25 (4.00%)  2/24 (8.33%) 
Dysgeusia  1  2/25 (8.00%)  5/25 (20.00%)  6/25 (24.00%)  3/24 (12.50%) 
Headache  1  1/25 (4.00%)  4/25 (16.00%)  3/25 (12.00%)  2/24 (8.33%) 
Hypoaesthesia  1  1/25 (4.00%)  1/25 (4.00%)  3/25 (12.00%)  1/24 (4.17%) 
Paraesthesia  1  1/25 (4.00%)  0/25 (0.00%)  2/25 (8.00%)  1/24 (4.17%) 
Psychiatric disorders         
Anxiety  1  2/25 (8.00%)  0/25 (0.00%)  0/25 (0.00%)  3/24 (12.50%) 
Insomnia  1  1/25 (4.00%)  2/25 (8.00%)  2/25 (8.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/25 (8.00%)  4/25 (16.00%)  5/25 (20.00%)  1/24 (4.17%) 
Dysphonia  1  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  1/24 (4.17%) 
Dyspnoea  1  1/25 (4.00%)  6/25 (24.00%)  2/25 (8.00%)  3/24 (12.50%) 
Nasal congestion  1  1/25 (4.00%)  0/25 (0.00%)  3/25 (12.00%)  1/24 (4.17%) 
Paranasal sinus hypersecretion  1  1/25 (4.00%)  0/25 (0.00%)  2/25 (8.00%)  1/24 (4.17%) 
Productive cough  1  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%)  0/24 (0.00%) 
Rhinorrhoea  1  2/25 (8.00%)  0/25 (0.00%)  4/25 (16.00%)  2/24 (8.33%) 
Sinus congestion  1  1/25 (4.00%)  6/25 (24.00%)  2/25 (8.00%)  2/24 (8.33%) 
Skin and subcutaneous tissue disorders         
Dry skin  1  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  2/24 (8.33%) 
Erythema  1  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  3/24 (12.50%) 
Generalised erythema  1  0/25 (0.00%)  0/25 (0.00%)  1/25 (4.00%)  2/24 (8.33%) 
Hyperhidrosis  1  0/25 (0.00%)  1/25 (4.00%)  1/25 (4.00%)  2/24 (8.33%) 
Pruritus generalised  1  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  2/24 (8.33%) 
Rash  1  2/25 (8.00%)  1/25 (4.00%)  3/25 (12.00%)  1/24 (4.17%) 
Skin lesion  1  1/25 (4.00%)  2/25 (8.00%)  1/25 (4.00%)  2/24 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Restriction Description:In accordance with the Clinical Trial Agreement between NIAID (DAIDS)and company collaborators,NIAID provides companies with a copy of any abstract,press release,or manuscript prior to submission for publication with sufficient time for company review and comment.The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and 5 business days for abstracts,to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
Phone: (617) 432-2829
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00376935     History of Changes
Other Study ID Numbers: A5212
10147 ( Registry Identifier: DAIDS ES )
ACTG A5212
First Submitted: September 14, 2006
First Posted: September 15, 2006
Results First Submitted: October 4, 2011
Results First Posted: January 30, 2012
Last Update Posted: June 30, 2015