The current success with biologicals, the fact that patients will not enrol in new clinical trials unless they have failed to respond to biological therapies, and the serious adverse events reported in certain trials of virus-mediated gene therapy are helping to focus the minds of gene therapists.
He has been in discussions with the Food and Drug Administration to start trials of the virus in human patients with any form of solid tumor cancer.
Currently there are three companies that completed the phase III clinical trials of whole virus inactivated vaccines.
NTR in combination with CB1954 has entered clinical trials for virus-directed enzyme prodrug therapy of cancer.
Her team eventually raised their target within eight months and preparations to begin a clinical trial of the virus are underway.
Interestingly, clinical trials of influenza B virus vaccination in children (Skowronski et al., 2011) and experimental infection of mice (Skowronski et al., 2012) showed that the Yamagata antigens produced a stronger immune response than the Victoria antigens.
Historically, Phase II and Phase III clinical trials of hepatitis C virus (HCV) treatments have defined sustained virological response (SVR) as an undetectable HCV RNA 24 weeks after end of treatment (SVR24).
We used pill count data from two recent HIV prevention trials of herpes simplex virus type 2 (HSV-2) suppression, to show that estimates of adherence vary substantially depending on assumptions that are made in analysing pill count data.
In this paper, we use data from two recent biomedical HIV prevention trials of herpes simplex virus type 2 (HSV-2) suppression, which both dispensed pills to be taken twice daily and used clinic-based pill counts of returned study product to measure adherence, to demonstrate how estimates of adherence vary depending on the assumptions that are made in analysing and reporting adherence data.
Between August 2004 and January 2005, women from local organizations of people living with HIV/AIDS (PLWHA) and from the University Hospital in Bobo-Dioulasso were recruited additionally to participate in two trials of Herpes Simplex Virus (HSV) suppressive therapy [ 6, 19], resulting in both FSWs and non-FSWs to form the cohort population.
"We may have to go ahead with clinical transplant trials of organs from virus-infected animals," says Stoye. "But it will be very important to monitor these viruses very carefully".
