Trial Outcomes & Findings for Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults (NCT NCT00376935)
NCT ID: NCT00376935
Last Updated: 2021-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Pre-entry, entry, study week 12
Results posted on
2021-11-04
Participant Flow
Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.
All randomized participants got at least one injection on each of three consecutive days.
Participant milestones
| Measure |
Palifermin Placebo
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
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.
|
Palifermin (40 mcg/kg)
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.
|
Palifermin (60 mcg/kg)
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 Study
STARTED
|
25
|
25
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Baseline characteristics by cohort
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47 years
INTER_QUARTILE_RANGE 7.8 • n=5 Participants
|
49 years
INTER_QUARTILE_RANGE 8.8 • n=7 Participants
|
45 years
INTER_QUARTILE_RANGE 9.7 • n=5 Participants
|
50 years
INTER_QUARTILE_RANGE 8.9 • n=4 Participants
|
49 years
INTER_QUARTILE_RANGE 8.9 • n=21 Participants
|
|
Age, Customized
Between 18 and 29 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Age, Customized
Between 30 and 39 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
2 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Age, Customized
Between 40 and 49 years
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
9 participants
n=4 Participants
|
42 participants
n=21 Participants
|
|
Age, Customized
Between 50 and 59 years
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
7 participants
n=5 Participants
|
8 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Age, Customized
Over 60 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
12 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
6 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing/ Unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
24 participants
n=4 Participants
|
99 participants
n=21 Participants
|
|
IV drug use
Never
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
19 participants
n=5 Participants
|
20 participants
n=4 Participants
|
81 participants
n=21 Participants
|
|
IV drug use
Previously
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
CD4 count
|
147 cell/mm^3
n=5 Participants
|
155 cell/mm^3
n=7 Participants
|
156 cell/mm^3
n=5 Participants
|
152 cell/mm^3
n=4 Participants
|
153 cell/mm^3
n=21 Participants
|
|
CD8 count
|
638 cell/mm^3
n=5 Participants
|
615 cell/mm^3
n=7 Participants
|
716 cell/mm^3
n=5 Participants
|
761 cell/mm^3
n=4 Participants
|
665 cell/mm^3
n=21 Participants
|
|
HIV-1 RNA Categorical
< 50 copies/mL
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
23 participants
n=5 Participants
|
24 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 52 copies/mL
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 77 copies/mL
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 81 copies/mL
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 84 copies/mL
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 88 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 97 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
= 69440 copies/mL
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
HIV-1 RNA Categorical
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-entry, entry, study week 12Population: Numbers presented use the intent-to-treat.
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.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)
|
15 cells/mm^3
Interval -16.0 to 23.0
|
11 cells/mm^3
Interval 2.0 to 32.0
|
12 cells/mm^3
Interval -2.0 to 25.0
|
8 cells/mm^3
Interval -13.0 to 35.0
|
SECONDARY outcome
Timeframe: At study entryOutcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Qualitative Hepatitis C Virus RNA
# of participants who had positive HCV results
|
4 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Qualitative Hepatitis C Virus RNA
# of participants who had negative HCV results
|
21 participants
|
22 participants
|
24 participants
|
19 participants
|
|
Qualitative Hepatitis C Virus RNA
# of missing
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From randomization to week 24Population: Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).
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.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24
|
2 participants
|
4 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24Population: This analysis was based on observed data only. No imputation was done for missing values. The number of participants with results available varies by study week for each treatment arm.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Change in Naive CD4+ Cell Counts From Randomization
Day 2 naive CD4+ change
|
-2 cells/mm^3
Interval -5.0 to 2.0
|
-2 cells/mm^3
Interval -10.0 to 3.0
|
-1 cells/mm^3
Interval -4.0 to 2.0
|
-2 cells/mm^3
Interval -6.0 to 1.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 1 naive CD4+ change
|
0 cells/mm^3
Interval -3.0 to 4.0
|
-2 cells/mm^3
Interval -6.0 to 2.0
|
-1 cells/mm^3
Interval -7.0 to 2.0
|
-1 cells/mm^3
Interval -4.0 to 2.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 2 naive CD4+ change
|
-1 cells/mm^3
Interval -8.0 to 4.0
|
-1 cells/mm^3
Interval -5.0 to 2.0
|
-1 cells/mm^3
Interval -4.0 to 3.0
|
0 cells/mm^3
Interval -7.0 to 3.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 4 naive CD4+ change
|
0 cells/mm^3
Interval -2.0 to 4.0
|
-2 cells/mm^3
Interval -4.0 to 1.0
|
1 cells/mm^3
Interval -4.0 to 3.0
|
0 cells/mm^3
Interval -3.0 to 5.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 8 naive CD4+ change
|
3 cells/mm^3
Interval -2.0 to 7.0
|
0 cells/mm^3
Interval -6.0 to 3.0
|
1 cells/mm^3
Interval -3.0 to 5.0
|
2 cells/mm^3
Interval -1.0 to 7.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 12 naive CD4+ change
|
1 cells/mm^3
Interval -6.0 to 5.0
|
1 cells/mm^3
Interval -7.0 to 4.0
|
1 cells/mm^3
Interval -3.0 to 5.0
|
0 cells/mm^3
Interval -6.0 to 5.0
|
|
Change in Naive CD4+ Cell Counts From Randomization
Week 24 naive CD4+ change
|
1 cells/mm^3
Interval -1.0 to 10.0
|
-1 cells/mm^3
Interval -7.0 to 4.0
|
2 cells/mm^3
Interval -4.0 to 8.0
|
1 cells/mm^3
Interval -4.0 to 7.0
|
SECONDARY outcome
Timeframe: randomization, study week 12Population: Participants who had CT thymus evaluations at both randomization and study week 12.
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.
Outcome measures
| Measure |
Palifermin Placebo
n=22 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=22 Participants
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.
|
Palifermin (40 mcg/kg)
n=22 Participants
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.
|
Palifermin (60 mcg/kg)
n=22 Participants
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.
|
|---|---|---|---|---|
|
Change in CT Thymic Index From Randomization
two-sizes-smaller thymus at week 12
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Change in CT Thymic Index From Randomization
one-size-smaller thymus at week 12
|
3 participants
|
6 participants
|
3 participants
|
3 participants
|
|
Change in CT Thymic Index From Randomization
unchanged thymus from randomization to week 12
|
11 participants
|
12 participants
|
13 participants
|
13 participants
|
|
Change in CT Thymic Index From Randomization
one-size-larger thymus at week 12
|
7 participants
|
4 participants
|
4 participants
|
6 participants
|
|
Change in CT Thymic Index From Randomization
two-sizes-larger thymus at week 12
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24Population: 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.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Day 2 CD4+ change
|
-4 cells/mm^3
Interval -15.0 to 22.0
|
2 cells/mm^3
Interval -13.0 to 15.0
|
-12 cells/mm^3
Interval -28.0 to 1.0
|
-5 cells/mm^3
Interval -21.0 to 16.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 1 CD4+ change
|
1 cells/mm^3
Interval -10.0 to 7.0
|
-12 cells/mm^3
Interval -31.0 to 15.0
|
-9 cells/mm^3
Interval -33.0 to 12.0
|
6 cells/mm^3
Interval -27.0 to 22.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 2 CD4+ change
|
-1 cells/mm^3
Interval -10.0 to 37.0
|
1 cells/mm^3
Interval -29.0 to 9.0
|
14 cells/mm^3
Interval -3.0 to 21.0
|
2 cells/mm^3
Interval -20.0 to 26.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 4 CD4+ change
|
6 cells/mm^3
Interval -17.0 to 25.0
|
1 cells/mm^3
Interval -17.0 to 9.0
|
16 cells/mm^3
Interval -15.0 to 29.0
|
2 cells/mm^3
Interval -35.0 to 28.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 8 CD4+ change
|
10 cells/mm^3
Interval -14.0 to 26.0
|
2 cells/mm^3
Interval -15.0 to 20.0
|
20 cells/mm^3
Interval -5.0 to 39.0
|
9 cells/mm^3
Interval -8.0 to 32.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 12 CD4+ change
|
14 cells/mm^3
Interval -17.0 to 27.0
|
11 cells/mm^3
Interval 1.0 to 32.0
|
12 cells/mm^3
Interval -6.0 to 38.0
|
8 cells/mm^3
Interval -13.0 to 35.0
|
|
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Week 24 CD4+ change
|
14 cells/mm^3
Interval -10.0 to 26.0
|
8 cells/mm^3
Interval -13.0 to 34.0
|
14 cells/mm^3
Interval 1.0 to 50.0
|
15 cells/mm^3
Interval 0.0 to 46.0
|
SECONDARY outcome
Timeframe: From randomization to study week 24Number 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.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Grade 3 or 4 Lab Toxicities From Randomization to Week 24
|
4 participants
|
5 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From randomization to week 24Number of subjects died.
Outcome measures
| Measure |
Palifermin Placebo
n=25 Participants
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 mcg/kg)
n=25 Participants
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.
|
Palifermin (40 mcg/kg)
n=25 Participants
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.
|
Palifermin (60 mcg/kg)
n=24 Participants
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.
|
|---|---|---|---|---|
|
Number of Death From Randomization to Week 24
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Palifermin Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Palifermin (20 Mcg/kg)
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Palifermin (40 Mcg/kg)
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Palifermin (60 Mcg/kg)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palifermin Placebo
n=25 participants at risk
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 Mcg/kg)
n=25 participants at risk
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.
|
Palifermin (40 Mcg/kg)
n=25 participants at risk
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.
|
Palifermin (60 Mcg/kg)
n=24 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/25
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/24
|
Other adverse events
| Measure |
Palifermin Placebo
n=25 participants at risk
Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
|
Palifermin (20 Mcg/kg)
n=25 participants at risk
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.
|
Palifermin (40 Mcg/kg)
n=25 participants at risk
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.
|
Palifermin (60 Mcg/kg)
n=24 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.0%
1/25
|
0.00%
0/25
|
0.00%
0/25
|
8.3%
2/24
|
|
Cardiac disorders
Palpitations
|
4.0%
1/25
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/24
|
|
Eye disorders
Eye pruritus
|
4.0%
1/25
|
0.00%
0/25
|
12.0%
3/25
|
4.2%
1/24
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/25
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/24
|
|
Eye disorders
Vision blurred
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25
|
8.0%
2/25
|
4.0%
1/25
|
4.2%
1/24
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25
|
20.0%
5/25
|
20.0%
5/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Dry mouth
|
8.0%
2/25
|
0.00%
0/25
|
12.0%
3/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25
|
4.0%
1/25
|
8.0%
2/25
|
0.00%
0/24
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25
|
12.0%
3/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Paraesthesia oral
|
4.0%
1/25
|
0.00%
0/25
|
12.0%
3/25
|
12.5%
3/24
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/25
|
4.0%
1/25
|
12.0%
3/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/25
|
0.00%
0/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25
|
20.0%
5/25
|
0.00%
0/25
|
4.2%
1/24
|
|
General disorders
Chest pain
|
4.0%
1/25
|
12.0%
3/25
|
0.00%
0/25
|
0.00%
0/24
|
|
General disorders
Chills
|
0.00%
0/25
|
12.0%
3/25
|
0.00%
0/25
|
0.00%
0/24
|
|
General disorders
Fatigue
|
12.0%
3/25
|
20.0%
5/25
|
8.0%
2/25
|
12.5%
3/24
|
|
General disorders
Oedema peripheral
|
4.0%
1/25
|
4.0%
1/25
|
8.0%
2/25
|
0.00%
0/24
|
|
General disorders
Pyrexia
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
4.2%
1/24
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25
|
4.0%
1/25
|
4.0%
1/25
|
4.2%
1/24
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
4/25
|
16.0%
4/25
|
12.0%
3/25
|
12.5%
3/24
|
|
Investigations
Aspartate aminotransferase increased
|
28.0%
7/25
|
32.0%
8/25
|
12.0%
3/25
|
20.8%
5/24
|
|
Investigations
Blood albumin
|
4.0%
1/25
|
8.0%
2/25
|
12.0%
3/25
|
4.2%
1/24
|
|
Investigations
Blood alkaline phosphatase increased
|
4.0%
1/25
|
12.0%
3/25
|
16.0%
4/25
|
12.5%
3/24
|
|
Investigations
Blood bicarbonate
|
16.0%
4/25
|
16.0%
4/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Investigations
Blood bilirubin increased
|
40.0%
10/25
|
24.0%
6/25
|
24.0%
6/25
|
29.2%
7/24
|
|
Investigations
Blood calcium decreased
|
16.0%
4/25
|
16.0%
4/25
|
0.00%
0/25
|
8.3%
2/24
|
|
Investigations
Blood cholesterol abnormal
|
8.0%
2/25
|
8.0%
2/25
|
0.00%
0/25
|
8.3%
2/24
|
|
Investigations
Blood creatinine increased
|
24.0%
6/25
|
4.0%
1/25
|
16.0%
4/25
|
16.7%
4/24
|
|
Investigations
Blood glucose abnormal
|
12.0%
3/25
|
12.0%
3/25
|
12.0%
3/25
|
16.7%
4/24
|
|
Investigations
Blood glucose decreased
|
12.0%
3/25
|
20.0%
5/25
|
12.0%
3/25
|
29.2%
7/24
|
|
Investigations
Blood glucose increased
|
36.0%
9/25
|
52.0%
13/25
|
64.0%
16/25
|
66.7%
16/24
|
|
Investigations
Blood phosphorus decreased
|
8.0%
2/25
|
12.0%
3/25
|
4.0%
1/25
|
4.2%
1/24
|
|
Investigations
Blood potassium decreased
|
8.0%
2/25
|
20.0%
5/25
|
16.0%
4/25
|
16.7%
4/24
|
|
Investigations
Blood potassium increased
|
4.0%
1/25
|
4.0%
1/25
|
8.0%
2/25
|
0.00%
0/24
|
|
Investigations
Blood sodium decreased
|
20.0%
5/25
|
28.0%
7/25
|
28.0%
7/25
|
20.8%
5/24
|
|
Investigations
Blood sodium increased
|
4.0%
1/25
|
12.0%
3/25
|
4.0%
1/25
|
0.00%
0/24
|
|
Investigations
Carbon dioxide
|
0.00%
0/25
|
4.0%
1/25
|
8.0%
2/25
|
12.5%
3/24
|
|
Investigations
Carbon dioxide abnormal
|
8.0%
2/25
|
16.0%
4/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Investigations
Lipase increased
|
4.0%
1/25
|
8.0%
2/25
|
12.0%
3/25
|
8.3%
2/24
|
|
Investigations
Neutrophil count decreased
|
16.0%
4/25
|
8.0%
2/25
|
16.0%
4/25
|
4.2%
1/24
|
|
Investigations
Platelet count decreased
|
20.0%
5/25
|
20.0%
5/25
|
20.0%
5/25
|
4.2%
1/24
|
|
Investigations
White blood cell count decreased
|
12.0%
3/25
|
4.0%
1/25
|
12.0%
3/25
|
8.3%
2/24
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.0%
1/25
|
4.0%
1/25
|
8.0%
2/25
|
4.2%
1/24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
3/25
|
12.0%
3/25
|
4.0%
1/25
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25
|
0.00%
0/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.0%
3/25
|
16.0%
4/25
|
0.00%
0/25
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
4.0%
1/25
|
8.0%
2/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Nervous system disorders
Dysgeusia
|
8.0%
2/25
|
20.0%
5/25
|
24.0%
6/25
|
12.5%
3/24
|
|
Nervous system disorders
Headache
|
4.0%
1/25
|
16.0%
4/25
|
12.0%
3/25
|
8.3%
2/24
|
|
Nervous system disorders
Hypoaesthesia
|
4.0%
1/25
|
4.0%
1/25
|
12.0%
3/25
|
4.2%
1/24
|
|
Nervous system disorders
Paraesthesia
|
4.0%
1/25
|
0.00%
0/25
|
8.0%
2/25
|
4.2%
1/24
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/25
|
12.5%
3/24
|
|
Psychiatric disorders
Insomnia
|
4.0%
1/25
|
8.0%
2/25
|
8.0%
2/25
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25
|
16.0%
4/25
|
20.0%
5/25
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/25
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25
|
24.0%
6/25
|
8.0%
2/25
|
12.5%
3/24
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
1/25
|
0.00%
0/25
|
12.0%
3/25
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
4.0%
1/25
|
0.00%
0/25
|
8.0%
2/25
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/25
|
8.0%
2/25
|
0.00%
0/25
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.0%
2/25
|
0.00%
0/25
|
16.0%
4/25
|
8.3%
2/24
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.0%
1/25
|
24.0%
6/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/25
|
0.00%
0/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25
|
0.00%
0/25
|
0.00%
0/25
|
12.5%
3/24
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/25
|
0.00%
0/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/25
|
4.0%
1/25
|
4.0%
1/25
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/25
|
0.00%
0/25
|
8.0%
2/25
|
8.3%
2/24
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
2/25
|
4.0%
1/25
|
12.0%
3/25
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.0%
1/25
|
8.0%
2/25
|
4.0%
1/25
|
8.3%
2/24
|
Additional Information
ACTG ClinicalTrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER