The Ojai Foundation Africa Project
9739 Ojai-Santa Paula Road, Ojai, California 93023
805 646-8343

The Mali HIV+ AIDS LDN Initiative:                                                                     Sept  04, 2007 

Compelling clinical experience suggests there is an innovative way to markedly improve the HIV/AIDS picture in Africa with an integrated medical and social/cultural approach.

Of the thousands of babies born HIV-positive each week, most die without medical care before the age of two. In sub-Saharan Africa there are 14 million AIDS orphans 50% of whom are estimated to be HIV-positive.  Although the standard HAART drugs for treating AIDS are being used more widely in Africa, it is estimated that they are available to less than 30% (and only 6% of children) of the people who need them.  The April 2007 report from World Health Organization (WHO), the Joint UN Program on HIV/AIDS (UNAIDS) and the UN Children's Fund (UNICEF) states that only 28 per cent of the estimated 7.1 million with AIDS in low or middle-income states (and untold millions with HIV positive status who will progress into full-blown AIDS without medication) were receiving treatment. The number of infants and children receiving treatment remains especially low not only due to lack of medicines but also lack of adequate medical care delivery for this challenging population.  UNICEF Executive Director Ann Veneman calls them "The missing face of the AIDS pandemic.” Even when available, these drugs are expensive, complex to administer, have significant side effects and require regular medical testing to be used safely. In addition, the HAART drugs are usually too toxic for children who, even more than adults, require the kind of medical management that is often unavailable. 

In regard to the primary medical goal of our proposed program, there are reasons for believing that an effective medical treatment already exists for preventing the HIV positive status from developing into full-blown AIDS.  Naltrexone is a generic, inexpensive US FDA-approved opiate antagonist that has been used widely to combat drug addiction for more than 20 years.  At less than one tenth the dose, “Low-Dose Naltrexone” (LDN) has been shown to be an effective immune system modulator that is non-toxic, non-addicting and requires administering a single capsule only once daily at bedtime.  LDN is also now available as a transdermal cream that is made for and particularly effective with children.  This cream has been used successfully in the treatment of some 10,000 immune-impaired children with autism over the past two years, principally under the direction of Dr. Jaquelyn McCandless, the “expatriate” medical coordinator for this project (See her book, “Children with Starving Brains,” Third Edition 2007.)  Before it can be used with HIV positive children, the efficacy of LDN must be tested in a controlled study with HIV positive adults.   When this is accomplished this non-toxic, easily administered medication can then be explored as an effective treatment in preventing HIV positive infants and children from ever developing full-blown AIDS as long as the medication is used daily.  If LDN were to be manufactured in Africa, (and there are interested parties who may want to do this) it is estimated that the cost would be less than $25 per year per child (probably less for capsules for adults).   

The safety as well as potential efficacy of LDN in preventing AIDS was discovered by Bernard Bihari, M.D., a Harvard-trained New York physician, in 1985.   Since that time Dr. Bihari has treated more than 350 patients, 94% of whom have remained HIV positive without progression into AIDS for up to 18 or more years so far.  Many of these individuals received only LDN and some used LDN as an auxiliary to the evolving HAART medications.  However, to this date no carefully designed controlled study has been done to prove the efficacy of LDN in HIV positive individuals as a preventative to developing AIDS.  To more deeply evaluate this hypothesis, Dr. Bihari, Dr. Abdel Kader Traore` (and other health officials at the University Hospital in Bamako in Bamako, Mali), and more recently Dr. Jaquelyn McCandless, have created a protocol for a controlled, non-placebo study involving 250 adult volunteers, all of whom are HIV positive but have not yet developed any AIDS symptoms.  The protocol will test efficacy of LDN alone compared to the current HAART medications as well as the combination of the two.  The Malian government is fully supportive of this study and will provide the HAART medications needed. 

 LDN has also been shown to be useful in the treatment of other autoimmune illnesses such as MS, ALS, diabetes, chronic fatigue syndrome, rheumatoid arthritis and Crohn’s Disease. Several new studies of such applications are currently being initiated in the US--for example, a Crohn’s second study at Penn State University, a crossover MS study at the University of California, San Francisco, and a clinical fibromyalgia study at Stanford University, all of which have been planned for 2007.

 As yet, there has not been support for a controlled LDN study for HIV+ AIDS in the United States, since those with AIDS in this country have ready access to the currently used HAART medications.  In addition, most US studies are designed by drug companies that are uniquely in a position to afford the huge cost of the required extensive trials. Drug companies are generally not interested in generic, low cost medications such as LDN. In regard to ethical issues, it is important to note that no one connected with the Mali study is associated with any drug company and both US consultants are working pro bono.

 International health experts agree that gender inequality and men’s culturally supported entitlement are primary factors in creating and continuing the AIDS catastrophe in many parts of Africa (and in other developing countries as well).  Current data indicates that 55%-65% of those now infected are girls or women, many with children who are then also infected. In an increasing number of villages there are only a few women left alive between the ages of 20 and 40. Recent studies indicate that the majority of HIV-positive women were infected by their husbands. Because of traditional social/gender mores, the vast majority of women do not have the capacity to refuse sex, cannot insist on condoms, and, therefore, cannot protect their own health. U.N. officials and others have stated that this epidemic will not abate until women are empowered to protect their own health and the health of their children.   

 Besides the high priority of bringing treatment to the vast number already suffering with AIDS, what is clearly needed to meet the situation in Africa is an integrated approach that helps to reduce the rate of infection through changes in the traditional social/gender patterns and, simultaneously, strengthens the immune systems of the large HIV-positive population—children and adults alike—to prevent them from moving into full-blown AIDS.  The long-term goal of the Mali Project is to demonstrate the efficacy of such a combined approach.

The Ojai Foundation, a 501(c) 3 organization devoted to education and research, is sponsoring an integrated, two-faceted HIV/AIDS initiative conducted by the University Hospital in Bamako, Mali that will:

1) Test the efficacy of a treatment protocol for those who are HIV positive that significantly reduces their chances of developing full-blown AIDS; and

2) Reduce the rate of HIV infection by encouraging changes in the ways men and women relate that will empower women to protect their health and the health of their children.

Mali has been chosen because their government officially supports this combined approach as the best way to combat the growing incidence of HIV/AIDS in their country and, although poverty is rampant, they are a relatively stable democratic nation unlike many African nations. In addition, Mali women are among the least empowered of any country in Africa. In a recent UNESCO survey of African women’s ability to shape their own lives and those of their children, 85% of Mali women indicated they did not feel empowered to make decisions that affect their intimate life. 

Concerning the second goal of the proposed program, the United Nations, the G8 countries, several large foundations, the Hunger Project and many smaller locally focused organizations have sponsored a variety of gender and health oriented educational programs in several African countries during the past 20 years. The primary thrust of these programs is based on educating individuals, particularly young women, about the nature and source of HIV infection. Although progress is being made, social mores change slowly and there remains a dishearteningly long way to go. In the proposed 56-week Mali Initiative we hope to accelerate this process by building on the educational programs and gender reconciliation initiatives that already exist in Mali using The Ojai Foundation’s many years of experience in dealing with gender communication issues.  This innovative program will include interviews as well as men’s, women’s and couples’ “councils” with volunteers from the population of 250 individuals that will be involved in the 56-week controlled LDN medical study. These councils will focus on improving gender communication, women’s empowerment and the reduction of violence in relationships.

This part of the program will be guided by Dr. Jack Zimmerman, communications and council specialist, longtime member of the Ojai Foundation’s Board of Directors and co-author of “The Way of Council,” (Bramble Books). Council has been a primary focus of The Ojai Foundation’s training program in gender and group communication for adults and children since 1980.  It has been successfully and widely used in schools such as Crossroads School in Santa Monica (where Dr. Zimmerman initiated their ongoing council program in 1983) and more recently (through the Los Angeles Unified School District’s “Council Practitioners’ Center”) at a growing number of public schools in Los Angeles. Council is also being used widely in places of business, schools, communities and families in other parts of the US, Israel, Europe and South Africa.

In December of 2006 Drs. McCandless and Zimmerman (husband and wife team) went to Mali to discuss the project with the staff of the University of Bamako Hospital. The visit confirmed that the research laboratory there is excellently equipped to carry out the study, and the Minister of HIV/AIDS, the Chairperson of their medical ethics committee and other significant Malian officials are fully in support of the program (see attached letter). 

A substantial portion of the approximately $275,000 required to fund the Mali initiative is being sought from concerned foundations and international AIDS organizations, such as the European African AIDS Project.  However, because such grants take time to manifest, we have decided to seek support from individual donors in the US and elsewhere in order to launch the program sooner. We have already conducted a council training for University of Bamako graduate students and faculty and counselors from the Bamako AIDS Center, May 2-4, 2007.   The trained facilitators are working with Dr. Zimmerman to develop a form of council that is suitable for the Malian Culture and will undergo further training when Drs. McCandless and Zimmerman return to Mali in October, 2007.

The need is great, the protocol is fully developed, the medical and research staff have been certified by the Mali Government, and the team of trained council facilitators are all ready to start the program.  In these last few months we have raised fifty percent of the funds needed and we remain committed to raise the full amount before the end of this summer.  The potential for an inexpensive, generic medication utilized in combination with encouraging change in gender mores that will significantly reduce the AIDS epidemic is enormous. Once successfully completed, this project can be replicated in other countries that are facing similar challenges.

We ask anyone touched by the situation in Africa to consider making as substantial a contribution as possible. We are doing the same from our personal resources. Please know that all of us involved with the project will be appreciative of any amount donors decide they can give.  A few people have told us they are concerned the amount they can afford is too small.  But many modest donations add up! Contributions can be sent to: The Ojai Foundation Africa Project, 9739 Ojai-Santa Paula Road, Ojai CA 93023.  We would also appreciate referrals to others (people and/or agencies) known personally by you who might be able and willing to contribute to this project.  Additional information including further details of the medical, education/communications and financial portions of the program as well as resumes of the principal investigators are available for anyone interested.

With appreciation for your consideration and support,
Jaquelyn McCandless, MD  and Jack Zimmerman, PhD

US Investigators
Jaquelyn McCandless, MD (“Expatriate” Clinical Coordinator/Monitor), Certified by the American Board of Psychiatry and Neurology, Author & Autism Specialist JMcCandless@prodigy.net. Phone 808 775-8142

Jack Zimmerman, PhD (Communications Consultant), Co-Chair, The Ojai Foundation Board of Directors JmZimmerman@yahoo.com. Phone 808 775-8142

Mali Investigators
Prof. Abdel Kader Traor�, MD (Principal Investigator) Department of Internal Medicine, H�pital National du Point G, Bamako, Mali

Ousmane Koita, PharmD, PhD (Co-Principal Investigator and Contact Person), Applied Molecular Biology Laboratory University of Bamako, Bamako, Mali