First of all, our apologies for the many months that have elapsed since we updated all of you about the Mali LDN Project. It has been a busy winter during which the clinical evaluation of LDN and the GECP Council Groups have progressed in significant ways:
- All clinical testing of Group 1 participants has been completed and the statistical analysis of the results is in full swing. The data include six extensive clinical evaluations of each participant taken over a period of nine months. The data include values of CD4, CD4%, Hemoglobin, Body/Mass Index and viral load of each participant. We are also in the process of evaluating the pre and post levels of Interferon-alpha for these participants. Although presentation of these results will have to await publication or presentation at the scientific conference that will take place in August in Bamako, we can say at this point that we have seen some encouraging trends regarding the use of LDN to stabilize the immune systems of HIV+ adults, particularly in regard to the CD4%. This measure is proving to be a more stable indicator of immune system health than the absolute CD4 count itself, very much in agreement with many other HIV studies that have been published recently. Thirty-eight of the original 57 members of this group finished the program (just meeting the protocol’s requirement for sample size) and data from eight others who almost completed the protocol will be used in the final analyses of the results.
- The clinical testing for Group 2 participants (HAART medication only) and Group 3 participants (LDN plus HAART medication) will be completed by the end of March as planned. This means we will be conducting an intensive analysis of the results of all groups within a few weeks. This will enable a quantitative comparison of the efficacy of LDN in combination with the HAART medications relative to the HAART medication alone. Forty-two members of Group 2 will finish the complete protocol and 44 from Group 3, more than is required by the protocol for statistical validity. Combining these results with the analysis of the LDN-only Group will provide us with the information we set out to discover three years ago!
- Seven of the eight ongoing Council Groups have now been completed and the eighth group will have its final session this month. In all, 61 men and women participated in these ongoing groups each of which met monthly for at least nine months. We are in the process of digesting the more than 75 evaluations that the various council leaders prepared after each council so that we can make a comprehensive report about the council program. Suffice it to say at this point, that we are amazed at the openness of communication about intimate matters that the groups have provided participants in the clinical study. Many men and women have been able to talk about health issues, the empowerment of women, the stigma of being HIV positive, and sexual intimacy in ways we could not have imagined considering the traditional patterns of the Malian patriarchal culture. It is clear that when given the opportunity to share sensitive information and deep feelings in a safe environment, many people are ready to seize the moment whatever the limitations of their cultural mores. The written comments from the facilitators have been illuminating–and inspirational.
- The Mali professional team is preparing several papers for a large scientific conference in Bamako in August. The papers will include two on the basic results of the clinical study, one on how LDN affects the immune system the way it does, one on the results of the council program (GECP) and one on making LDN available in Mali (and eventually elsewhere in Africa) for both adults and children, once the clinical study is completed. Widespread availability has always been a part of our long-term vision in conducting this program. In particular we are now exploring what steps will be necessary to make LDN available to HIV+ Malian infants and young children in cream form.
- On the financial front, the monthly cost of the program has dropped to an average of about $4,000 now that the clinical testing is coming to a close and the council groups are ending. Our estimate for the support needed from March 1 to the program’s completion on July 31, 2010, is $12,000. A large portion of these funds will be used to do the comprehensive analysis of the data and the preparation of the scientific papers. We are deeply grateful for the more than 100 donations—large and small–from more than 75 donors that we have received since the program started in 2007. To help us complete the funding, new donations from previous and new supporters will be greatly appreciated.
- We will be posting additional news soon.