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TMC125-C214 - Early Access of TMC125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options.

PI:  Jonathan Moorman, M.D., Ph.D.

This is a phase III, expanded access protocol designed to provide a novel drug, TMC125, to individuals with HIV-1 infection who have limited treatment options.  Eligible subjects will be recruited from the ETSU Center of Excellence for HIV based on defined enrollment criteria and be given TMC125 along with a backbone regimen of ARVs.  Subjects will be provided the drug for as long as is necessary until FDA approval is given.


A Multi-national, Multi-center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h For Ten Days in Subjects With Clostridium difficile-Associated Diarrhea

PI:  Jonathan Moorman, M.D., Ph.D.

This double-blind Phase 3 trial will compare the safety and efficacy of an investigational antibiotic versus vancomycin.

At study entry, Visit 1, subjects will be randomized at each site to receive the oral investigational antibiotic or oral vancomycin in a double blind manner. Subjects will be evaluated clinically during and after the 10-day course of therapy for cure or failure and, if cured, followed for a four-week period thereafter for recurrence. Clinical response (cure/failure, recurrence) will be based on the Investigator's assessment of clinical parameters, most importantly diarrhea. The subject will be evaluated for changes in the number and character of stools and for other signs/symptoms or laboratory values suggestive of CDAD. Toxin A and B assays will be performed at the End-of-Therapy Visit or Early Termination Visit for subjects who fail. Subjects who are cured will be evaluated for diarrhea during the post-therapy follow-up time frame to Study Days 36-40 (Post-study Visit). Subjects with diarrhea will be evaluated for the presence of toxin A and B. The co-administration of any oral or parenteral antibacterials will be captured up to the Post-study Visit (Days 36-40).   


A Phase 2, Open-Label, Non-Comparative Study of Doripenem In The Treatment of Nosocomial And Ventilator-Associated Pneumonia In Hospitals Where Pseudomonas aeruginosa May Be A Prevalent Pathogen

PI:  Felix Sarubbi, M.D.

This is an open-label, Phase 2, non-comparative, multicenter study of doripenem involving approximately 200 adult male and female subjects with NP or VAP hospitalized at institutions where P. aeruginosa may be a prevalent pathogen. NP subjects must meet a certain high-risk profile and VAP subjects must have a Clinical Pulmonary Infection Score (CPIS) >6 at baseline to be eligible to participate in the study. At study entry, all eligible subjects will receive doripenem 1 gram (g) intravenously (i.v.) over 4 hours every 8 hours with a potential dosage adjustment to 500 mg after approximately 48 hours depending upon the doripenem minimum inhibitory concentration (MIC) of the pathogen(s).

Subjects will be assessed at: Baseline/Study Entry (Study Day 1), daily while on study drug, End-of-Therapy (EOT) within 24 hours of last dose, Test-of-Cure (TOC) 7-14 days after EOT, and Late Follow-up (LFU) 28-35 days after EOT.

The protocol adheres to all IND and other pertinent guidelines relevant to the conduct of clinical trials. Its main objective is to extend solid microbiologic and other preclinical findings into the patient care arena and establish if doripenem, a new and more potent carbapenem, is capable of eradicating VAP-associated pathogens, especially Pseudomonas aeruginosa, that are resistant to imipenem. It should be considered exploratory in nature and, accordingly, will be both open-label and non-comparative in design.
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