HIV Infections
Conditions
Keywords
Treatment Experienced
Brief summary
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.
Detailed description
Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression. The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts. This study will last 24 weeks. Participants will be randomly assigned to one of four arms: * Arm A participants will receive placebo * Arm B participants will receive palifermin 20 mcg/kg * Arm C participants will receive palifermin 40 mcg/kg * Arm D participants will receive palifermin 60 mcg/kg Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.
Interventions
DRUGPalifermin
Keratinocyte growth factor administered via injection
DRUGPalifermin placebo
Keratinocyte growth factor placebo administered via injection
Sponsors
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV infected * Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry * CD4 count of 200 cells/mm3 or less within 30 days prior to study entry * Documented CD4 count obtained at study screening * Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry * Willing to use acceptable forms of contraception for the duration of the study
Exclusion criteria
* Active pancreatitis * Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), or investigational ART within 30 days prior to study entry * Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time. * Allergy or sensitivity to any component of palifermin * Prior treatment with palifermin or other keratinocyte growth factors * Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation * Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded. * Active cancer * HIV-1 RNA levels \>200 copies/mL within 6 months prior to study entry * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) | Pre-entry, entry, study week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 | From randomization to week 24 | 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. |
| Change in Naive CD4+ Cell Counts From Randomization | randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24 | — |
| Change in CT Thymic Index From Randomization | randomization, 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. |
| Qualitative Hepatitis C Virus RNA | At study entry | — |
| Grade 3 or 4 Lab Toxicities From Randomization to Week 24 | From randomization to study week 24 | 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. |
| Number of Death From Randomization to Week 24 | From randomization to week 24 | Number of subjects died. |
| Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24 | — |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| 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. | 25 |
| 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. | 24 |
| Total | 99 |
Baseline characteristics
| Characteristic | Palifermin Placebo | Total | Palifermin (60 mcg/kg) | Palifermin (40 mcg/kg) | Palifermin (20 mcg/kg) |
|---|---|---|---|---|---|
| Age, Continuous | 47 years INTER_QUARTILE_RANGE 7.8 | 49 years INTER_QUARTILE_RANGE 8.9 | 50 years INTER_QUARTILE_RANGE 8.9 | 45 years INTER_QUARTILE_RANGE 9.7 | 49 years INTER_QUARTILE_RANGE 8.8 |
| Age, Customized Between 18 and 29 years | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| Age, Customized Between 30 and 39 years | 4 participants | 13 participants | 2 participants | 6 participants | 1 participants |
| Age, Customized Between 40 and 49 years | 13 participants | 42 participants | 9 participants | 8 participants | 12 participants |
| Age, Customized Between 50 and 59 years | 4 participants | 27 participants | 8 participants | 7 participants | 8 participants |
| Age, Customized Over 60 years | 4 participants | 16 participants | 5 participants | 3 participants | 4 participants |
| CD4 count | 147 cell/mm^3 | 153 cell/mm^3 | 152 cell/mm^3 | 156 cell/mm^3 | 155 cell/mm^3 |
| CD8 count | 638 cell/mm^3 | 665 cell/mm^3 | 761 cell/mm^3 | 716 cell/mm^3 | 615 cell/mm^3 |
| HIV-1 RNA Categorical < 50 copies/mL | 22 participants | 91 participants | 24 participants | 23 participants | 22 participants |
| HIV-1 RNA Categorical = 52 copies/mL | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| HIV-1 RNA Categorical = 69440 copies/mL | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| HIV-1 RNA Categorical = 77 copies/mL | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| HIV-1 RNA Categorical = 81 copies/mL | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| HIV-1 RNA Categorical = 84 copies/mL | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| HIV-1 RNA Categorical = 88 copies/mL | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| HIV-1 RNA Categorical = 97 copies/mL | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| HIV-1 RNA Categorical Missing | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| IV drug use Never | 20 participants | 81 participants | 20 participants | 19 participants | 22 participants |
| IV drug use Previously | 5 participants | 18 participants | 4 participants | 6 participants | 3 participants |
| Race/Ethnicity, Customized Asian, Pacific Islander | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 6 participants | 25 participants | 6 participants | 4 participants | 9 participants |
| Race/Ethnicity, Customized Hispanic (Regardless of Race) | 3 participants | 20 participants | 6 participants | 8 participants | 3 participants |
| Race/Ethnicity, Customized Missing/ Unknown | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 15 participants | 52 participants | 12 participants | 12 participants | 13 participants |
| Region of Enrollment United States | 25 participants | 99 participants | 24 participants | 25 participants | 25 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 22 Participants | 90 Participants | 23 Participants | 22 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 25 | 24 / 25 | 25 / 25 | 24 / 24 |
| serious Total, serious adverse events | 0 / 25 | 1 / 25 | 1 / 25 | 0 / 24 |
Outcome results
Primary
Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)
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
Population: Numbers presented use the intent-to-treat.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Palifermin Placebo | Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) | 15 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) | 11 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) | 12 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values) | 8 cells/mm^3 |
Comparison: 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.p-value: 0.1996Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.3135Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.3662Wilcoxon (Mann-Whitney)
Secondary
Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.
Time frame: randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin Placebo | 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 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 12 CD4+ change | 11 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 4 CD4+ change | 1 cells/mm^3 |
| Palifermin (20 mcg/kg) | 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 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 8 CD4+ change | 2 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 24 CD4+ change | 8 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 1 CD4+ change | -12 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Day 2 CD4+ change | 2 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 4 CD4+ change | 16 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Day 2 CD4+ change | -12 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 1 CD4+ change | -9 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 2 CD4+ change | 14 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 8 CD4+ change | 20 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 12 CD4+ change | 12 cells/mm^3 |
| Palifermin (40 mcg/kg) | 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 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 2 CD4+ change | 2 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 24 CD4+ change | 15 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 12 CD4+ change | 8 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 1 CD4+ change | 6 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Day 2 CD4+ change | -5 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 8 CD4+ change | 9 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | Week 4 CD4+ change | 2 cells/mm^3 |
Secondary
Change in CT Thymic Index From Randomization
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
Population: Participants who had CT thymus evaluations at both randomization and study week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin Placebo | Change in CT Thymic Index From Randomization | one-size-smaller thymus at week 12 | 3 participants |
| Palifermin Placebo | Change in CT Thymic Index From Randomization | two-sizes-smaller thymus at week 12 | 1 participants |
| Palifermin Placebo | Change in CT Thymic Index From Randomization | unchanged thymus from randomization to week 12 | 11 participants |
| Palifermin Placebo | Change in CT Thymic Index From Randomization | two-sizes-larger thymus at week 12 | 0 participants |
| Palifermin Placebo | Change in CT Thymic Index From Randomization | one-size-larger thymus at week 12 | 7 participants |
| Palifermin (20 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-larger thymus at week 12 | 0 participants |
| Palifermin (20 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-smaller thymus at week 12 | 0 participants |
| Palifermin (20 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-smaller thymus at week 12 | 6 participants |
| Palifermin (20 mcg/kg) | Change in CT Thymic Index From Randomization | unchanged thymus from randomization to week 12 | 12 participants |
| Palifermin (20 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-larger thymus at week 12 | 4 participants |
| Palifermin (40 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-smaller thymus at week 12 | 3 participants |
| Palifermin (40 mcg/kg) | Change in CT Thymic Index From Randomization | unchanged thymus from randomization to week 12 | 13 participants |
| Palifermin (40 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-larger thymus at week 12 | 4 participants |
| Palifermin (40 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-smaller thymus at week 12 | 1 participants |
| Palifermin (40 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-larger thymus at week 12 | 1 participants |
| Palifermin (60 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-smaller thymus at week 12 | 3 participants |
| Palifermin (60 mcg/kg) | Change in CT Thymic Index From Randomization | one-size-larger thymus at week 12 | 6 participants |
| Palifermin (60 mcg/kg) | Change in CT Thymic Index From Randomization | unchanged thymus from randomization to week 12 | 13 participants |
| Palifermin (60 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-smaller thymus at week 12 | 0 participants |
| Palifermin (60 mcg/kg) | Change in CT Thymic Index From Randomization | two-sizes-larger thymus at week 12 | 0 participants |
Secondary
Change in Naive CD4+ Cell Counts From Randomization
Time frame: randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 12 naive CD4+ change | 1 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 8 naive CD4+ change | 3 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 24 naive CD4+ change | 1 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 2 naive CD4+ change | -1 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 1 naive CD4+ change | 0 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Week 4 naive CD4+ change | 0 cells/mm^3 |
| Palifermin Placebo | Change in Naive CD4+ Cell Counts From Randomization | Day 2 naive CD4+ change | -2 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 4 naive CD4+ change | -2 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 8 naive CD4+ change | 0 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Day 2 naive CD4+ change | -2 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 1 naive CD4+ change | -2 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 24 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 12 naive CD4+ change | 1 cells/mm^3 |
| Palifermin (20 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 2 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 4 naive CD4+ change | 1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Day 2 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 1 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 2 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 8 naive CD4+ change | 1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 12 naive CD4+ change | 1 cells/mm^3 |
| Palifermin (40 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 24 naive CD4+ change | 2 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 1 naive CD4+ change | -1 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 24 naive CD4+ change | 1 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 12 naive CD4+ change | 0 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Day 2 naive CD4+ change | -2 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 2 naive CD4+ change | 0 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 8 naive CD4+ change | 2 cells/mm^3 |
| Palifermin (60 mcg/kg) | Change in Naive CD4+ Cell Counts From Randomization | Week 4 naive CD4+ change | 0 cells/mm^3 |
Secondary
Grade 3 or 4 Lab Toxicities From Randomization to Week 24
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palifermin Placebo | Grade 3 or 4 Lab Toxicities From Randomization to Week 24 | 4 participants |
| Palifermin (20 mcg/kg) | Grade 3 or 4 Lab Toxicities From Randomization to Week 24 | 5 participants |
| Palifermin (40 mcg/kg) | Grade 3 or 4 Lab Toxicities From Randomization to Week 24 | 4 participants |
| Palifermin (60 mcg/kg) | Grade 3 or 4 Lab Toxicities From Randomization to Week 24 | 6 participants |
Secondary
Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24
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
Population: Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palifermin Placebo | Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 | 2 participants |
| Palifermin (20 mcg/kg) | Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 | 4 participants |
| Palifermin (40 mcg/kg) | Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 | 2 participants |
| Palifermin (60 mcg/kg) | Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24 | 1 participants |
Secondary
Number of Death From Randomization to Week 24
Number of subjects died.
Time frame: From randomization to week 24
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Palifermin Placebo | Number of Death From Randomization to Week 24 | 0 participants |
| Palifermin (20 mcg/kg) | Number of Death From Randomization to Week 24 | 0 participants |
| Palifermin (40 mcg/kg) | Number of Death From Randomization to Week 24 | 0 participants |
| Palifermin (60 mcg/kg) | Number of Death From Randomization to Week 24 | 0 participants |
Secondary
Qualitative Hepatitis C Virus RNA
Time frame: At study entry
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Palifermin Placebo | Qualitative Hepatitis C Virus RNA | # of participants who had positive HCV results | 4 participants |
| Palifermin Placebo | Qualitative Hepatitis C Virus RNA | # of missing | 0 participants |
| Palifermin Placebo | Qualitative Hepatitis C Virus RNA | # of participants who had negative HCV results | 21 participants |
| Palifermin (20 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had positive HCV results | 2 participants |
| Palifermin (20 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of missing | 1 participants |
| Palifermin (20 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had negative HCV results | 22 participants |
| Palifermin (40 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had negative HCV results | 24 participants |
| Palifermin (40 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had positive HCV results | 1 participants |
| Palifermin (40 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of missing | 0 participants |
| Palifermin (60 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had positive HCV results | 5 participants |
| Palifermin (60 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of missing | 0 participants |
| Palifermin (60 mcg/kg) | Qualitative Hepatitis C Virus RNA | # of participants who had negative HCV results | 19 participants |