Proposed Projects: National

Cholesterol Study. To ascertain if dietary supplement(s) may improve blood lipid profile associated with antiretroviral therapy by reducing elevated LDL cholesterol. Secondary endpoints include the potential for such an intervention to induce a reduction in triglyceride level as well as an increase in HDL cholesterol. FIAR has developed a preliminary concept sheet for this study (available upon request). The proposed study design is a factorial or tree design, the base of which is niacin versus inositol hexanicotinate (another form of niacin). A third placebo arm is under consideration. Patients in each arm would then be further randomized to receive carnitine or placebo. Then a third randomization would further divide patients to receive hawthorn berry extract (or possibly guggul lipids). This design would allow a better understanding of whether individual agents or some combination would be most effective in managing antiretroviral related blood lipid disturbances.

Combination herbal therapy. A number of botanical interventions have been identified that may have some direct impact on slowing HIV disease by lowering viral load. Some have been studied individually with results ranging from equivocal to modest. But as AZT monotherapy is not advisable due to the rapid development of resistance, it may well be that combinations may be effective. One case series of reports that Mr. Carter worked on for DAAIR included curcumin (Curcuma longa, L.), glycyrrhizin (an extract of licorice), SPV-30 (an extract of boxwood, Buxus sempervirens, L.) and bitter melon (Momordica charantia, L.) A number of other botanicals have been identified for which there is a reasonable basis to conduct small, focused clinical studies. This may be of particular relevance to resource poor areas, where antiretroviral therapy is not yet widely available. It may also be important for people who wish to delay disease progression as long as possible to delay the need for antivirals, as well as to extent the length of a structured treatment interruption.

Silybum marianum

Monolaurin Study or lauric acid capsules (900 mg or 3 capsules/day) for the following:

• delaying the appearance of HSV-1,2 sores in people with this problem
• reducing levels of HIV-1
• reducing levels of CMV viraemia
• delaying decline in CD4+ cell counts
• delaying appearance of shingles (VZV)

HCV/HIV Coinfection Studies. FIAR is also interested in developing protocols for hepatitis C (HCV) and HIV coinfection. As noted above, FIAR and Mount Sinai are studying milk thistle in HIV/HCV co-infection. Additional studies are planned using the panel of surrogate markers of liver fibrosis and/or hepatitis viral load. Interventions of interest include NAC, alpha lipoic acid and various combinations of botanical medicines rooted in Chinese, Ayurvedic and African traditions.

Other studies were raised in a July meeting of the AIDS Treatment Activist Coalition and may be reviewed in the associated report on the CAM Affinity Group. A study proposal for Moducare Sterinols has also been suggested.

Proposed Projects:
International Integrative Models of Prevention & Treatment

FIAR is considering studies to be conducted in some resource poor nations. Due to the extreme need in these areas, FIAR plans to prioritize development of these studies over domestic studies. In countries like India, Thailand, Nepal and in African nations, ARV treatment is unavailable for the majority.

However, there are reasons to believe that some botanical medicines may be able to slow progression, delaying the need for ARV. The best effect of such interventions is probably earlier in disease and in delaying progression. Thus, it is critical to create an environment where treatment and prevention are linked. This may give people confidence to be tested earlier. Even small increments in the reduction of the overall progression rate could have enormous benefits both individually and for local economies by delaying the need for costlier ARV interventions and OI management, prophylaxis and treatment.

In addition, HIV testing and other diagnostics are not always widely available. As has recently become more widely accepted and understood, testing is stymied when treatment is unavailable.

FIAR wishes to develop models that combine treatment, access to traditional medicine care, evaluation of such approaches in a clinical trial setting along with providing access to ARV therapy and treatment for opportunistic infections for those in need of it. This may serve as a model for comprehensive care, while recognizing the need to minimize costs. Validated technologies such as spot-blood testing for diagnosing HIV disease (obviating the need for tubes of blood and the need for refrigeration), alternative p24 testing for viral load, Dynabeads for CD4+ counts, etc., will be considered as needed.

More detailed budgets for such programs will be developed as the concept sheets are developed. However, a guide is provided through the model of testing of antibiotic therapies for tuberculosis. As reflected in The Economics of TB Drug Development from the Global Alliance for TB Drug Development (October, 2001), the per patient cost of early phase II studies is approximately $1,881 in Uganda (including fixed and variable costs). FIAR envisions conducting studies at single sites of approximately 30-50 patients. However, these figures will be more accurately assessed when the study interventions are specified, the best methodology identified and other ancillary costs for study implementation are established. However, this gives us a figure of approximately $94,000 for a 50-patient study. Through the use of various validated, lower-cost diagnostics and other interventions, we may be able to pare those costs down.

Legal agreements will be drawn up prior to study commencement to address issues related to the commercialization or patenting, should such a need arise, of any interventions shown to be of benefit. Such benefit, of course, may be transferred to other countries and cultures, including people living with HIV in the United States. See the discussion on "Fair Trade."

One goal of these projects is also to locally introduce antiviral therapy, probably using generic medications available in India, to local communities. Currently, there is no access to antiviral therapy in Nepal, for example. We hope to structure a study with thresholds of CD4 count or viral load to establish crossover arms into ARV therapy should the traditional intervention not be adequate to control disease activity.

The South India Project:
Working with Gandeepam in Kilavayal to study Siddha regimen for managing HIV disease; Mr. Carter was invited as one of the international delegates and presenters to the First International Conference on Siddha Medicine in May, 2002. At this time, several reputable practitioners were contacted, along with the remarkable people that have created the Gandeepam botanical gardens and traditional physicians. (Please see the report found in this document.)

The Nepal Project: Treatment Added to Prevention:
Identifying reputable traditional practitioners to conduct similarly structured studies as the South India project. This will augment the existing and growing condom and lube distribution program. Participants in the Nepal Project have expressed serious concern over the lack of treatment and are very desirous to see treatment be made available. Many already have a significant prevalence of sexually transmitted diseases. However, they are reluctant to test for HIV as a positive result is merely viewed as a death sentence. The limitation to development of this project so far is not yet having identified reputable traditional practitioners. FIAR hopes to remedy this situation in the near future, perhaps in part through contacts being developed in the Dharmsala Project.

Thus, having such interventions available will make it easier to link testing with treatment. People will gain confidence that a positive test result may be accompanied, as needed, with access to treatment.

A Dharmsala Project: Testing, Counselling and Treatment:
FIAR is working with Dr. Namgyal Tenzin to develop a potential program to help the Tibetan community-in-exile in Dharmsala, India. This would begin with a seroprevalence survey, as it is not clear how many Tibetans in the refugee and exile community are HIV-infected. If a threshold number of infected individuals are discovered (say 10), a clinical evaluation of Tibetan medicine might be started. Again, this would also include development of a prevention program as well as introduction of ARV for those in whom traditional medicines were not adequate. Finally, this project would help to support the desperate need for healthcare infrastructure development.

Thai Holistic Hospital and Rosana Tositrakul:
The Phaya Mengrai Hospital in Chiang Rai, working with the HIV+ community group known as Mittraparp may be an excellent area to begin another model project. The interventions to treat and manage HIV disease and symptoms have been under investigation for some time here. Unfortunately, most individuals still lack access to antiretroviral medication, despite the availability of generically-priced AIDS and OI drugs in Thailand. With the help of Ashoka winner, Rosana Tositrakul of Thaihof in Bangkok, it may be possible to set up a program that would address unmet prevention needs, arrange for a clinical study of traditional medicines and help to provide access to antiretroviral treatment.

Traditional Healers in Africa:
Various programs have identified many African traditional healers who are trained as messengers of risk reduction, while in other areas, healers are recruited to facilitate directly observed therapy (DOT) in TB treatment and linking women to PAP smear services. The study FIAR is proposing would help to evaluate what traditional healers are doing to treat people. In consultation with healers and local community, this may help to identify promising botanical interventions that may slow HIV disease, manage symptoms or treat opportunistic infections. This falls in line with FIAR's desire to be a community-driven organization. That is, FIAR does not dictate what is studied--it comes from what people in the community want to understand better. FIAR, working with Gifts of Health, is currently reviewing projects in Tanzania, Senegal and South Africa.

Fair Trade
As appropriate, FIAR will establish agreements prior to conducting studies in developing nations that will protect local intellectual property rights. FIAR will seek, in those agreements, to assure that Fair Trade practices are adopted whenever local use of botanicals is initiated. FIAR recognizes that all too often, international interests are at the expense of local populations. However, local communities are developing new ways to help their local economy in ways that alleviate poverty. One example is the coffee growers of Mexico. To the extent such economic systems may be possible in areas where botanicals are harvested for use in clinical studies (e.g., African nations, central and South America, India, Nepal, Thailand), FIAR will seek to establish at the outset agreements with partners that any commercial advantage that may arise from positive study results will accrue to local populations. That is, to the communities of people living with HIV/AIDS and to the farmers and harvesters of botanicals. This, in turn, may have further benefits to the local environment by encouraging the preservation of natural ecosystems as valuable commodities to be cared for and nurtured wisely.

Please write to FIAR with your comments about these ideas as well as suggestions for clinical studies that you would like to see conducted! (Note: there isn't a return page after you click submit, but if you watch the bottom of your browser, you'll see that the message was sent.)

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