Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10147 | Registry Identifier | DAIDS ES | |
| ACTG A5212 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | NETWORK |
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Participants will receive palifermin placebo injection on Days 1, 2, and 3 |
|
| 2 | Experimental | Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3 |
|
| 3 | Experimental | Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3 |
|
| 4 | Experimental | Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palifermin | Drug | Keratinocyte growth factor administered via injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-entry, entry, study week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Hepatitis C Virus RNA | At study entry | |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M. Jacobson, MD | Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC CRS | Los Angeles | California | 90033 | United States | ||
| UCLA CARE Center CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16848276 | Background | Aiuti F, Mezzaroma I. Failure to reconstitute CD4+ T-cells despite suppression of HIV replication under HAART. AIDS Rev. 2006 Apr-Jun;8(2):88-97. | |
| 11986226 | Background | Franco JM, Rubio A, Martinez-Moya M, Leal M, Merchante E, Sanchez-Quijano A, Lissen E. T-cell repopulation and thymic volume in HIV-1-infected adult patients after highly active antiretroviral therapy. Blood. 2002 May 15;99(10):3702-6. doi: 10.1182/blood.v99.10.3702. |
Not provided
Not provided
All randomized participants got at least one injection on each of three consecutive days.
Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Palifermin (20 mcg/kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Palifermin placebo | Drug | Keratinocyte growth factor placebo administered via injection |
|
|
| From randomization to week 24 |
| 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 | 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. | randomization, study week 12 |
| 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 |
| 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. | From randomization to study week 24 |
| Number of Death From Randomization to Week 24 | Number of subjects died. | From randomization to week 24 |
| Los Angeles |
| California |
| 90035 |
| United States |
| Stanford CRS | Palo Alto | California | 94304 | United States |
| Ucsd, Avrc Crs | San Diego | California | 92103 | United States |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | United States |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136-1013 | United States |
| The Ponce de Leon Ctr. CRS | Atlanta | Georgia | 30308 | United States |
| IHV Baltimore Treatment CRS | Baltimore | Maryland | 21201 | United States |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | United States |
| Washington U CRS | St Louis | Missouri | 63108-2138 | United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| Columbia P&S CRS | New York | New York | 10032-3732 | United States |
| Trillium Health ACTG CRS | Rochester | New York | 14607 | United States |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | United States |
| Unc Aids Crs | Chapel Hill | North Carolina | 27514 | United States |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | United States |
| Case CRS | Cleveland | Ohio | 44106 | United States |
| MetroHealth CRS | Cleveland | Ohio | 44109 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Therapeutics CRS | Nashville | Tennessee | 37204 | United States |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | United States |
| 15516965 | Background | van den Brink MR, Alpdogan O, Boyd RL. Strategies to enhance T-cell reconstitution in immunocompromised patients. Nat Rev Immunol. 2004 Nov;4(11):856-67. doi: 10.1038/nri1484. |
| 12672400 | Background | Ye P, Kourtis AP, Kirschner DE. Reconstitution of thymic function in HIV-1 patients treated with highly active antiretroviral therapy. Clin Immunol. 2003 Feb;106(2):95-105. doi: 10.1016/s1521-6616(02)00024-4. |
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.
| FG002 | 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. |
| FG003 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| IV drug use | Number | participants |
| ||||||||||||||||
| CD4 count | Median | Inter-Quartile Range | cell/mm^3 |
| |||||||||||||||
| CD8 count | Median | Inter-Quartile Range | cell/mm^3 |
| |||||||||||||||
| HIV-1 RNA Categorical | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Numbers presented use the intent-to-treat. | Posted | Median | Inter-Quartile Range | cells/mm^3 | Pre-entry, entry, study week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Qualitative Hepatitis C Virus RNA | Posted | Number | participants | At study entry |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment). | Posted | Number | participants | From randomization to week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Naive CD4+ Cell Counts From Randomization | 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. | Posted | Median | Inter-Quartile Range | cells/mm^3 | randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Participants who had CT thymus evaluations at both randomization and study week 12. | Posted | Number | participants | randomization, study week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24. | 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. | Posted | Median | Inter-Quartile Range | cells/mm^3 | randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Number | participants | From randomization to study week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Death From Randomization to Week 24 | Number of subjects died. | Posted | Number | participants | From randomization to week 24 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 25 | 25 | 25 | ||
| EG001 | 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. | 1 | 25 | 24 | 25 | ||
| EG002 | 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. | 1 | 25 | 25 | 25 | ||
| EG003 | 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. | 0 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tongue discolouration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood albumin | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bicarbonate | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood cholesterol abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Carbon dioxide | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Carbon dioxide abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG ClinicalTrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D051523 | Fibroblast Growth Factor 7 |
| ID | Term |
|---|---|
| D005346 | Fibroblast Growth Factors |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Between 30 and 39 years |
|
| Between 40 and 49 years |
|
| Between 50 and 59 years |
|
| Over 60 years |
|
| Male |
|
| Black Non-Hispanic |
|
| Hispanic (Regardless of Race) |
|
| Asian, Pacific Islander |
|
| Missing/ Unknown |
|
| Previously |
|
| = 52 copies/mL |
|
| = 77 copies/mL |
|
| = 81 copies/mL |
|
| = 84 copies/mL |
|
| = 88 copies/mL |
|
| = 97 copies/mL |
|
| = 69440 copies/mL |
|
| Missing |
|
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. |
| Superiority or Other (legacy) |
| 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. | Wilcoxon (Mann-Whitney) | 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. | 0.3135 | 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. | Shift parameter | -4 | 1-Sided | 98.4 | 17 | 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. | Superiority or Other (legacy) |
| 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. | Wilcoxon (Mann-Whitney) | 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. | 0.3662 | 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. | Shift parameter | -4 | 1-Sided | 98.4 | 22 | 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. | Superiority or Other (legacy) |
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| 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. |
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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.
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| OG003 | 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. |
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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. |
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