University of Illinois at Chicago (UIC) Project WISH (Women Invested in Stopping HIV) is applying to become a Clinical Trials Unit. We are proposing that our organization be the only Clinical Research Site for his CTU. We are currently an HIV Vaccine Trial Unit for the HIV Vaccine Trials Network (HVTN) and are proposing to continue that relationship. A letter of commitment from the HVTN leadership accompanies this application. We are also proposing to participate in the Microbicide priority research area. We do not have a network affiliation or prior agreement for this activity. In addition to current participation in the HVTN, Project WISH participated in the HIVNET Clinical Trial 014. We also provided the highest risk women (including the seroconverters) for the VaxGen VAX004 trial with an HIV incidence of 3.3% for that trial. Approximately one third of the women and one third of the African Americans in that trial came from Project WISH. This unit is also engaged in NICHD-funded HIV mucosal immunity studies in this same target population and has been included in the HVTN's proposal to continue to investigate these issues as they relate to vaccine effectiveness. Given our access to the high-risk women, expansion of the program to include microbicide trials is appropriate. Project WISH is a free-standing research unit in the University of Illinois Medical Center. We have our own clinic which is dedicated solely to research. This clinic has several exam rooms, space for clinical trial records, and a small laboratory for the processing and storing of samples. The University of Illinois Hospital Investigational Drug Services provides pharmacy services and we have access to all of hospital laboratory services. The Principal Investigator has his own laboratory with hoods and storage facilities that are used for PBMC processing. ADMINISTRATIVE COMPONENT:
| Dawson, Liza; Garner, Sam; Anude, Chuka et al. (2015) Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial. Clin Trials 12:394-402 |
| Hammer, Scott M; Sobieszczyk, Magdalena E; Janes, Holly et al. (2013) Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med 369:2083-92 |
| Novak, Richard M; Metch, Barbara; Buchbinder, Susan et al. (2013) Risk behavior among women enrolled in a randomized controlled efficacy trial of an adenoviral vector vaccine to prevent HIV acquisition. AIDS 27:1763-70 |
