New Blog posts follow this introduction.

The Vision

The AIDS situation in Africa has reached a pandemic level. More than 26 million people are HIV-positive, over 6 million have active AIDS and 11 million have already died as a result of the devastating illness. Of those newly infected, over 60% are women, many with children also infected. In sub-Saharan Africa one-half of the 14 million orphans are estimated to be HIV+ and 50% of untreated newborn HIV+ babies will die before the age of two. HAART drugs are available to less than 25% of those who need them (only 6% of children) due to cost and lack of medical personnel. Not only are these drugs costly and complex to administer, they are often too toxic for children who are even more difficult to manage medically. Our recent discovery of the effectiveness of NALTREXONE in ultra low doses (LDN) to strengthen the immunity of autistic children started us on this pathway of wanting to help with HIV/AIDS in Africa. If proven effective in our controlled, clinical study in Mali, this easily managed, inexpensive non-toxic drug can keep HIV-positive persons from progressing to AIDS. The implications are enormous.
 
Of equal urgency is the need to decrease the incidence of initial HIV infections. It is widely accepted now by international health experts and local authorities alike that gender inequality and men’s traditional cultural entitlement including violence to women are important factors in creating and maintaining the AIDS catastrophe in many developing countries. In Africa the majority of women who are HIV positive have been infected by their husbands. Traditional gender mores dictate that women cannot refuse sex and cannot insist on condoms. U.N. officials, the Mali Government and many others have stated that this epidemic will not abate until women become empowered to protect their own health and the health of their children. Our Mali program deals directly with this challenge by bringing the men and women in our clinical study together in council-groups to explore issues of health, intimacy and empowerment.

Early Fall, 2011

It’s been many months again since our last post, so for those of you who have wondered what was happening, our apologies.

We have good news!

In August the Journal of AIDS and HIV Research (JAHR) accepted the two papers we submitted that describe the two phases of the Mali Project initiated four years ago!  The first paper:

“Single cohort study of the effect of Low Dose Naltrexone on the evolution of immunological, virological and clinical state of HIV+ adults in Mali”

describes the results of giving LDN to a group of 57 HIV positive adults, all of whose CD4 count fell between 350 and 600 cell/mm3 and who showed no symptoms of AIDS.  The second paper:

“Impact of Low Dose Naltrexone (LDN) on antiretroviral therapy (ART) treated HIV+ adults in Mali: A single blind randomized clinical trial”

describes the results of comparing the health of two groups of 57 adults each, all of whom were HIV positive, had a CD4 count below 350 cells/mm3 and were receiving standard ARV medications.  One group was also given a 3.5 mg dose of LDN and the other a placebo. The purpose of this phase of the study was to see if LDN improved the standard ARV treatment in a significant way.

As you know the Mali team of physicians and researchers was a large one. Both papers have fourteen authors, including the two of us, but not including 26 other professionals who supported the program at the three large health facilities that were involved. A large part of the challenge of doing such an ambitious program was coordinating this group of forty people working half way around the world!

We can’t describe the actual results that are reported in the papers until they are actually published—which we expect to be this month or in October but we can say that the results were encouraging enough to warrant further exploration of LDN in the treatment of HIV positive adults. By doing this extended clinical study we also showed that LDN was a safe medication with no observable side effects.

Now that we have successfully completed the program, the team leaders in Mali tell us that local health officials should be open to a proposal to make LDN available in the country. Our strategy will be to take advantage of the world-wide use of LDN in treating autism to familiarize the Mali Health Ministry with its potential in treating that disorder. Autism is not prevalent in Mali (the country is too poor to provide vaccines with mercury based preservatives!) and much less controversial than HIV/AIDS.  Familiarizing the Mali medical community with LDN in the context of autism will also direct attention to the use of LDN (in dermatological form) for use with children and infants—which as you remember was a major part of the original project vision. Once LDN is available in pharmacies for autism, it will be less of a challenge to encourage its use in treating other auto-immune illnesses, including, of course, HIV/AIDS. We’ll have more to say about this phase of the Project in our next post.

We want to take this moment of publication to thank all of our many generous donors, some of whom supported the program since its inception. There were more than a hundred of you who made this project possible. We also want to thank the Mali Team who persevered over a period of almost four years to fulfill the protocol.  Working with the core team became a gratifying experience both professionally and personally.

The official brief statement of acknowledgment that appears in the two papers reads as follows:

“The authors acknowledge the individual donors who supported the Program through our fiscal sponsor, The Ojai Foundation, in Southern California.   The Malian Principal Investigators, medical team and other staff were supported by the two US authors affiliated with this Foundation, who acted as medical advisor and program coordinator.  We also acknowledge: Hussein Alfa Nafo,  who was instrumental in supporting the clinical program, provided ongoing translation support and acted as the US authors’ primary contact in Mali; David Gluck MD, who provided much needed medical and programmatic advice along the way; and Dr. H.A. (Skip) Lenz, whose pharmacy provided the LDN and placebos at cost.  We are indebted to the Mali Ministry of Health which provided the ART medications at no cost to the Program and the Mali Ethics Committee whose guidance  insured that the program was conducted within the strong health policies of the Mali Government. 

Finally, the authors want to express our deep admiration and gratitude to Dr. Bernard Bihari, whose pioneering work with LDN led to his conceiving of the Mali Program in 2004.”