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What is a Clinical Trial?
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A clinical trial is a research study designed to investigate a new drug or treatment
regimen. There are several kinds of clinical trials…
- Phase I: Study of a drugs safety and clearance from the body. Often done in
patients without any disease (health volunteers), who are generally paid to
participate.
- Phase II: A study of efficacy (does it work?), safety and "best" dose in
patients with disease. Generally, 50 to 300 patients may be studied.
- Phase III: A trial with a large patient enrollment that is used to determine
efficacy in many patients with the disease. The data from Phase III trials often
serves as the final information prior to Food and Drug Administration (F.D.A.) approval
of a new drug or use.
- Phase IV: Following F.D.A. approval, investigators or the company may try to
use the drug for other indications or in a different dosing manner than that found on
the approval.
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Current Clinical Trials Offered (Updated February 2003)
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| DISEASE |
TREATMENT |
PATIENT TYPE |
STATUS |
PHASE |
| Hepatitis C |
PEG-Interferon + Ribavirin + VX950 |
Naive |
Enrolling |
Phase II |
| Hepatitis C |
PEG-Interferon + NM283 |
Non-responders |
In Progress |
Phase II |
| Hepatitis C |
PEG-IFN + NM283 |
Naive |
In Progress |
Phase II |
| Hepatitis C |
GSK Antifibrotic |
Non-responders |
Enrolling |
Phase II |
| HCV/HIV |
Interferon Maintenance |
HCV/HIV Non-responders |
Enrolling |
Phase IV |
Other Trials for Patients with HIV Infection at the ACTG Website (Click here)
If Interested in Further Information Contact:
Susan Sibert, RN
Study Coordinator
UNIVERSITY OF CINCINNATI
(513)584-5245
(513)584-2363
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