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

This study has been completed.
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00376935
First received: September 14, 2006
Last updated: November 25, 2013
Last verified: November 2013
Results First Received: October 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Palifermin
Drug: Palifermin placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All randomized participants got at least one injection on each of three consecutive days.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Palifermin Placebo     Palifermin (20 Mcg/kg)     Palifermin (40 Mcg/kg)     Palifermin (60 Mcg/kg)  
STARTED     25     25     25     24  
COMPLETED     25     25     25     24  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Palifermin Placebo     Palifermin (20 Mcg/kg)     Palifermin (40 Mcg/kg)     Palifermin (60 Mcg/kg)     Total  
Number of Participants  
[units: participants]
  25     25     25     24     99  
Age  
[units: years]
Median ( Inter-Quartile Range )
  47  
  ( 42 to 50 )  
  49  
  ( 43 to 54 )  
  45  
  ( 39 to 54 )  
  50  
  ( 46 to 57 )  
  49  
  ( 42 to 55 )  
Age, Customized  
[units: participants]
         
Between 18 and 29 years     0     0     1     0     1  
Between 30 and 39 years     4     1     6     2     13  
Between 40 and 49 years     13     12     8     9     42  
Between 50 and 59 years     4     8     7     8     27  
Over 60 years     4     4     3     5     16  
Gender  
[units: participants]
         
Female     3     2     3     1     9  
Male     22     23     22     23     90  
Race/Ethnicity, Customized  
[units: participants]
         
White Non-Hispanic     15     13     12     12     52  
Black Non-Hispanic     6     9     4     6     25  
Hispanic (Regardless of Race)     3     3     8     6     20  
Asian, Pacific Islander     1     0     0     0     1  
Missing/ Unknown     0     0     1     0     1  
Region of Enrollment  
[units: participants]
         
United States     25     25     25     24     99  
IV drug use  
[units: participants]
         
Never     20     22     19     20     81  
Previously     5     3     6     4     18  
CD4 count  
[units: cell/mm^3]
Median ( Inter-Quartile Range )
  147  
  ( 110 to 180 )  
  155  
  ( 126 to 194 )  
  156  
  ( 116 to 197 )  
  152  
  ( 112 to 192 )  
  153  
  ( 116 to 194 )  
CD8 count  
[units: cell/mm^3]
Median ( Inter-Quartile Range )
  638  
  ( 394 to 887 )  
  615  
  ( 464 to 722 )  
  716  
  ( 575 to 999 )  
  761  
  ( 502 to 1099 )  
  665  
  ( 467 to 954 )  
HIV-1 RNA Categorical  
[units: participants]
         
< 50 copies/mL     22     22     23     24     91  
= 52 copies/mL     1     0     0     0     1  
= 77 copies/mL     1     0     0     0     1  
= 81 copies/mL     1     0     0     0     1  
= 84 copies/mL     0     0     1     0     1  
= 88 copies/mL     0     1     0     0     1  
= 97 copies/mL     0     1     0     0     1  
= 69440 copies/mL     0     1     0     0     1  
Missing     0     0     1     0     1  



  Outcome Measures
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1.  Primary:   Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)   [ Time Frame: Pre-entry, entry, study week 12 ]

2.  Secondary:   Qualitative Hepatitis C Virus RNA   [ Time Frame: At study entry ]

3.  Secondary:   Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24   [ Time Frame: From randomization to week 24 ]

4.  Secondary:   Change in Naive CD4+ Cell Counts From Randomization   [ Time Frame: randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24 ]

5.  Secondary:   Change in CT Thymic Index From Randomization   [ Time Frame: randomization, study week 12 ]

6.  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 ]

7.  Secondary:   Grade 3 or 4 Lab Toxicities From Randomization to Week 24   [ Time Frame: From randomization to study week 24 ]

8.  Secondary:   Number of Death From Randomization to Week 24   [ Time Frame: From randomization to week 24 ]

9.  Secondary:   Change in T-cell Receptor Excision Circles (TRECs)From Randomization   [ Time Frame: randomization, study week 12, week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

10.  Secondary:   Percent of CD3 and CD4 T Cells That Are Enriched in Recent Thymic Emigrants (RTE)   [ Time Frame: randomization, study week 12, week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

11.  Secondary:   Ratio Signal Joint TREC (sjTREC)/DBetaJBetaTREC as Quantified in Peripheral Blood Mononuclear Cell (PBMC)   [ Time Frame: randomization, study week 12, week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No

12.  Secondary:   sjTREC Relative Frequency in PBMC   [ Time Frame: randomization, study week12, week 24 ]
Results not yet posted.   Anticipated Posting Date:   12/2012   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.gov@sdac.harvard.edu


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00376935     History of Changes
Other Study ID Numbers: A5212, 10147, ACTG A5212
Study First Received: September 14, 2006
Results First Received: October 4, 2011
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration