HAART + Remune Update
As you may know, Remune is a therapeutic vaccine developed by the Immune Response Corp. In geneva Dr Fred Valintine, of NYU-Bellevue Medical Center, reported 20 week data on a 32 week study of HAART+Remune. A detailed report of his findings are on this web site (click here to link to Dr Valentine's article on the immune system). It was reported that nice lymphocyte proliferative responses to HIV antigens were observed in the HAART+Remune group but not in the HAART+placebo group. These responses may be similar to responses Dr Bruce Walker has observed by treating individuals during acute infection with HAART. Walker says he has observed CD4 specific HIV antigen responses similar to those seen in long-term non-progressors.
Immune Response Corp and Agouron reported an update of the Valentine study. They reported on Monday Oct 26 that at week 32 of those receiving HAART+Remune 13/15 individuals had <1 copy/ml (optical density=background). They used the Ultrsensitive viral looad assay. Four individuals prematurely dropped out of this arm. Originally 22 individuals were randomized to this arm. In the control arm receiving HAART+placebo 6/12 had <1 copy/ml (OD+background). The difference between the two arms showed a trend but was not statistically significant (p=0.09) . As well, the baseline viral load was only 8,000 copies/ml, and the baseline CD4 was 580. All individuals received Crixivan+AZT/3TC. These 32 week results are intriguing and promising but preliminary. Larger and longer studies are required to confirm these results.
Several studies are being planned to explore vaccines including Remune plus HAART. One ACTG proposal is to use multiple vaccines, and alternate injections of them in combination with HAART. HAART+IL-2+vaccines may be explored, as well as HAART+IL-2 will be.