The WF10 P3 differs from the P2 at Vanderbilt in both the size of the trial, and the fact that everyone in the patient population was receiving HAART.
A few have been wondering what the effect of HAART might be: would mortality with HAART and WF10 be significantly different than mortality with WF10 alone (ie., Vanderbilt)?
P3 interim results revealed "...46 clinical endpoints among 36 of the 193 enrolled patients, including 15 deaths and 31 new opportunistic conditions."
aidsmeds.com
Results (not interim) from Vanderbilt...
"A phase II trial at Vanderbilt School of Medicine in 1995 in 19 people offered more evidence of WF10's abilities. Participants all had advanced AIDS (mean CD4 cell count of 39 cells/mm3). Ten people received four cycles of WF10 and nine received four cycles of placebo. The trial was stopped when a planned, interim analysis showed that people taking WF10 were clearly doing much better than those receiving placebo. Those in the WF10 groups had significant improvements relative to those in the control group in immunologic parameters such as median white blood cell, lymphocyte, and other immune system cell (CD19 and CD35) values. People receiving WF10 had a lower incidence of OIs and hospitalizations, and longer survival times. Ten infections including four cases of Pneumocystis carinii pneumonia (PCP) occurred in the control group compared with three in the WF10 group, none of which were PCP. Five people in the control group experienced 53 days of hospitalization and 110 home-care days, while those receiving WF10 required neither hospitalization nor home care. Eighteen months after the study ended, eight of the nine people in the control group had died compared to two of the ten in the WF10 group. Results were published in the August 1998 journal Infection."
Looking at the information above, one can make statistical inferences, as Joe and Mark have posted. It would would be good to know, however, what the effect of HAART is, without WF10, as the immune system begins to fail.
There's a good series of articles on CATIE concerning AIDS and HAART. They don't allow their material to be edited or posted, so here are the links...
catie.ca
catie.ca |
