History of HIVEX Treatment
The principal inventors of the HIVEX treatment, Boris Kokorin and Leonid Weiser, began to work with HIV-infected patients in the early 1990s. They worked in Moscow, encouraged by the Russian government, with teams of physicists, mathematicians, mechanical and electronic engineers. In the mid 1990s a trial arranged by New York doctor specializing in the treatment of those with HIV, Dr Brown, was carried out on six Americans. You can hear one of those treated speaking about his treatment - click on “George” in the menu.
After Perestroika Boris and Leonid left Russia to find investment and a suitable location to continue research and treatment. Some work was done in Austria, in the UK (Cambridge University), Finland (Joensuu University). This increased the understanding the physics and biochemistry involved.
Nelson Mandela, 2002, after making a deliberate gesture by publicly embracing HIV-infected AIDS activist Zackie Achmat; he also disclosed that three members of his own family had died of AIDS.
In 1999, moved by the growing crisis in South Africa, Boris and Leonid,took the technology to Durban, helped by Cameron Scott.
With a small amount of backing, they began to carry out trials and treatments, working with local doctors and the University of Kwa-Zulu Natal, Nelson Mandela School of Medicine. By 2000 HIVEX had a waiting list of thousands of people who wanted to be treated, referred by their doctors or friends. This, despite the stigma which surrounds HIV in South Africa; and despite the fact that many of those who have HIV do not tell others, and suffer in lonely isolation, unaware that many of their friends and acquaintances are suffering similarly.
In 2003 HIVEX received the financial backing of BAE Systems. This enabled a large Phase 2 dose-ranging trial to be carried out. That trial established that the treatment was safe, did indeed significantly decrease their rate of apoptosis ("programmed" cell death) and levels of viable lymphocytes. Post hoc analysis established that adequately dosed patients were 5.7 times less likely to die, be hospitalised, or need ARVs. Some of the findings were so stong (statistically significant) that HIVEX sought registration for the use of their equipment after the Phase II trial, whereas normally, a Phase III trial would be carried out, in order to evaluate efficacy once optimal dose had been established.
Treatments on patients other than in clinical trials were stopped at the request of BAES; whilst HIVEX waited for approval from the South African Ministry of Health..What happened to the thousands of people waiting for treatment? We can only guess.
Other conditions were applied at that time - no publicity : no publication of trial reports; no talking at conferences, pending approval from European authorities. Those authorities did confirm safety, and significant effects on lymphocytes, apoptosis, and adverse events in adequately dosed patients but withheld European Certification (C.E. marking) on the basis that there was no primary proof that the treatment affected the virus. In their words, HIVEX could prove that the treatment worked in adequately dosed patients, consistent with the virus being rendered inactive, but couldn't show that the virus had been damaged. Why not?
The HIV virus is very small. It is difficult to see, even with an electron microscope. Only around 2% of the virus in an affected person is active in the blood. 98% of the virus lies in the central nervous system, epithelial cells and elsewhere. ARVs effectively banish virus from the blood, and doctors and scientists are used to evaluating whether a person is being treated effectively through doing a "viral load" test on the patient's blood. ARVs effectively banish virus from the blood, and "viral load" test on the blood of patients who have taken suitable ARVs for several months is typically undetectable. However, the virus remains in reservoirs in the central nervous system and elsewhere in latent form, re-entering the blood if the patient takes a drugs holiday.
The European authorities would have registered the HIVEX treatment if we had shown significant drop in "viral load" in the blood. But we couldn't. The trial carried out was not "powered" for efficacy - for that, we would need tests on around 900 patients in a "Phase III" study. In any event, EMF is not intended to remove virus from the blood: it is designed to disable it. Some patients show a drop in viral load, and some don't. 88% of adequately dosed HIVEX treated patients showed a significant drop in their rate of apoptosis and a significant rise in viable lymphocytes irrespective of the fragments of virus in the blood. Possibly the RNA fragments persist, but are damaged. We want to study this aspect more. We believe that EMF Treatment affects the virus wherever it is located in the body, active or latent. No hiding places. We hope to be able to show that the virus is damaged : we believe that the presence of viral particles in the blood is irelevant.
When the European Authorities refused certification (“CE marking”) for the use of HIVEX equipment to treat patients with HIV, HIVEX renewed its attempts to obtain formal approval from the South African authorities, to permit advertisement of claims and marketing of the equipment. (Until now, there has been no formal process in South Africa for the approval of medical devices, beyond an assessment of electrical safety). The equipment’s safety was approved; and ministerial sanction is awaited. During this whole period, 2002-2010, treatment was not provided to any patients outside of the formal trials.
In 2010 BAE Systems gave up its shareholding in HIVEX, freeing those who remained involved to treat. Given our financial constraints, we can treat in a small way. We want to make progress, fast.
Photos by Danielle Kummer