The informal study of SPV-30, an extract of boxwood evergreen manufactured by Arkophara, France, has now enrolled over 100 individuals. The French data will not be available until late 1996 or early 1997. In the US, we hope to have the study fully enrolled by the end of July or early August, 1995. Formal analyses of the US data will be available by the spring of 1996. 85 individuals have completed two months of the informal US study. 30 have completed four months, and 6 have now completed the entire six-month study. It is far too early to begin making judgments as to SPV-30's long-term effectiveness against HIV/AIDS, but some of the preliminary data, particularly PCR data, are encouraging.

PCR Data Results

Because we only requested, but did not require, PCR tests for participants to enroll in the study, we only have PCR data from 25 people after two months and from eight people after four months. After two months, 16 participants had decreases in viral load. Eight had increases. The overall median(1) decrease was .26 log. For those 16 who experienced a decrease, the median drop was .80 log. For the eight who experienced increases, the median increase was .13 log. Interestingly, participants with a baseline viral load of greater than 40,000 had more impressive results. 15 of 17 individuals with a viral load of greater than 40,000 at baseline had decreases in viral load after two months on SPV-30. The median decrease in this group was .35 log. For the 15 who experienced viral load decreases, the median decrease was .58 log. For the two who experienced a viral load increase, the median increase was .09 log.

CD4 Results

The Phase I study in France indicated increases in CD4s after six months. The US study does not indicate CD4 increases until after the fourth month. The median change in CD4s for 85 individuals after two months was -3 CD4s and -5.4% from baseline to month two. After four months, the median change in CD4s for 30 individuals was +1 CD4 and 0%. For the five individuals who have completed the six month study, the median increase was +52 CD4s and +19.8%. For the 44 individuals who had fewer than 200 CD4s at baseline, the median change was -5 and -12.8% after two months. After four months the median change for 15 individuals was +2 and +19.8%. No one with fewer than 200 CD4s at baseline has completed the six month study at this time.

CD8 Results

After two months, 78 individuals provided CD8 data. The median change in CD8s for this group was +47 CD8s and +6.1%. 28 individuals have provided four months data. The median change was 115 CD8s and +17.6%. Only 4 have completed the study with a median change of +609 CD8s and 6.3%. For the 22 individuals who had fewer than 500 CD8s at baseline, the median change after two months was +34 CD8s and +10.8%. After four months, the median change for 7 individual was +141 and +64.3%. No one with fewer than 500 CD8s at baseline has completed the six month study at this time.

Summary

As mentioned above, it is far too early to draw any conclusions regarding the long term efficacy of SPV-30. However, the overall preliminary data do indicate decreases in viral load and increases in CD8s. CD4s have increased for those few who have completed the six month study, but we need more data. We will continue to provide progress reports of the raw data on a monthly basis as the study proceeds. At the conclusion of this study, outside experts, statisticians, researchers and doctors will review the data and assist us in the preparation of a formal report.

(1) Median is defined as the middle value when you rank changes from highest to lowest. In other words, half the responses are higher than the median. Half were lower.