| ACTG 5212 FACT SHEET |
| A Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Recovery
(ACTG 5212, Version 1.0)
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Purpose of This Trial:
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This study is being done to determine if palifermin (recombinant human keratinocyte growth factor [rHuKGF]) can increase CD4+ T cell counts in HIV infected people with suppressed viral loads but low CD4+ T cell counts. The safety of palifermin will also be evaluated.
Palifermin used for this purpose is experimental, so the U.S. Food and Drug Administration (FDA) allows Palifermin to be used only in research with a limited number of people.
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| Requirements to Enter Study: |
- HIV-positive men and women 18 years or older
- Currently on HIV drugs for at least 6 months
- CD4 T cell count less than 200
- HIV viral load less than 200 copies/mL for at least 6 months
- Not pregnant or breast feeding
- No androgens, immunomodulators (growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), and/or investigational HIV medications within 30 days
- No evidence of pancreatitis
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| Medications While on Study: |
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At entry you will be randomly assigned (like flipping a coin) to one of four treatment groups. This drug is given through a vein in your arm (intravenously or IV) once a day for 3 days at entry.
- Arm A: palifermin placebo (no active medication) daily for 3 days
- Arm B: palifermin 20 mcg/kg IV daily for 3 days
- Arm C: palifermin 40 mcg/kg IV daily for 3 days
- Arm D: palifermin 60 mcg/kg IV daily for 3 days
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| Length of Study: |
| About 6 months |
| Schedule of Study Appointments (about 1 hour each):
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Screening, pre-entry, entry and at weeks 1, 2, 4, 8, 12, and 24. Visits include physical exams and blood draws. CT scans (special X-rays) are performed at entry and week 12.
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| Reimbursement: |
| Exams, study medication, and lab tests are provided at no cost.
$20.00 per study visit and $10 for each CT scan.
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| Benefits: |
| You get to play an active role in your own health care, and you will help others by contributing to medical research.
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| Contact: |
| Call 731-3184 and ask for the screening nurse
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