If patience is a virtue, then those of us involved with the Mali LDN Study must be becoming virtuous people! When we started the Initiative in Mali several years ago, we expected to be completed by the beginning of 2009 and certainly by now. However, as we have reported before, the stigma of being HIV positive in Mali and the stringent CD4 count requirements of our protocol have led to a very long enrollment process.
However, we have news to report!
Enrollment in all three groups–LDN only, LDN and HAARV meds, and HAARV meds only–was completed at the end of July (171 participants in all). With that milestone passed, the program will definitely complete in early March of 2010. The other piece of good news is that more than 80% of the testing has now been completed. That means 80% of the CD4 and hemoglobin tests that are done six times on each participant have been completed. For each participant, these tests are done at the start of the clinical period, after 15 days, and at the end of the first, third, sixth and ninth months. Most of the testing will be done by the end of this year with only the last few enrolled participants still undergoing testing in early 2010.
Meanwhile the GECP council groups have continued steadily with about 65 participants in the monthly meetings at any one time. As participants complete their nine-month clinical testing and leave the protocol, new participants have joined the councils. There are both men’s, women’s and mixed councils going, with attendance remarkably high in the majority of circles. The council discussions have dealt with the basic issues surrounding HIV/AIDS plus other issues of general importance. These topics include dealing with the HIV/AIDS stigma (within and outside the family), how to convince partners to commit to protected sex, experiencing the freedom that comes from acceptance of the illness and the possibility of healing, the empowerment of women to protect their health and to express their feelings in intimate matters, whether it’s better to marry someone who is also HIV positive, how to generate enough income to feed the family and so on. The groups have been lively and remarkably open for a society in which intimate communication between men and women is virtually non-existent. Obviously, at least many of the program participants were ready to break through long-standing Malian gender cultural barriers. We are now beginning to analyze the semi-quantitative evaluations of each council provided by the council facilitators. There are now six council leaders working in Bamako, all of whom have been trained by us and have been leading councils now for at least a year—some more than two! The success of the council work has been encouraging and gratifying.
The formal analysis of the CD4, hemoglobin and interferon-alpha data will have to wait until the testing is completed. However, a preliminary review of the CD4 data shows a few trends:
- Unavoidably, there are uncontrolled variables in the study, primarily because Mali is the second poorest country in sub-Saharan Africa—with a poverty rate that is currently increasing. This affects many issues including the dietary habits of participants, participant compliance with taking the meds, the prevalence of other infections and illnesses besides HIV/AIDS, etc. These factors may explain why, thus far, it appears that taking LDN alone is not sufficient to increase the CD4 levels for most of the HIV positive individuals in our study. However, the LDN does seem to prevent some participants from large drops in CD4 count and from developing AIDS symptoms over the short haul (nine months). Whether this is significant has yet to be determined. We plan to compare the change in CD4 count for the LDN-only group with the 80 count average yearly loss that the literature reports for HIV positive individuals who are not being treated at all to see if the change in CD4 levels in the group taking only LDN is significantly less that this level. We will have to wait until early 2010 to make this determination.
- The participants who are taking LDN and the standard HAART medication and those taking just the HAART meds are showing significant increases in CD4 count. How much of this increase is due to the LDN and how much to the HAART medication cannot be fully determined until after all the testing is completed.
- We also plan to look at the CD4 percentage as a measure of the strength of the immune system rather than just the CD4 count alone. Recent studies indicate that the percentage of the CD4 cells to the total white count may be a more useful and stable measure of immune system strength that the CD4 count alone. We will also be looking into more complex measures of immune system strength that includes hemoglobin and other data available in the study.
Apart from whatever the final statistical results turn out to be, it is already clear that we have learned a lot about implementing an LDN protocol—the first such quantitative clinical study for HIV+ anywhere in the world, as far as we know. This in itself will contribute to LDN being accepted into the medical community and we trust will spur further LDN studies in other countries. Another significant plus to the study is that efforts are already underway to arrange for LDN to be available in Mali once the study is completed next spring. This will be a boon to the population—and not only for those who are HIV positive. From Mali, the availability can spread to other African countries.
On the financial front, the current monthly budget is running about $5,700, so we have to raise about $40,000 to cover the final seven months of the program. This will include all the analyses and writing of papers that will follow the end of the clinical study next spring. As always, we will greatly appreciate whatever support readers of this web site can provide, as our own funds are virtually tapped out. We want to thank all those who have supported this program, both financially and through their efforts to inform both the medical profession and potential users of LDN of the medication’s enormous potential for strengthening the immune system.
Tags: Reports from Abroad // 3 Comments »
