Clinical trials

Since 1991, about 2,000 people have been treated with the HIVEX Treatment, in Russia, Austria, and South Africa. Various studies and trials have been conducted in Russia, the U.K., U.S.A., and South Africa (See list at bottom of the page). The founders of HIVEX moved to South Africa in 1999 because they felt that South Africa needed this treatment most. The largest South African trial was conducted by the University of KwaZulu Natal in 2003-5. Its purpose was to confirm safety and monitor dose response. Over 1,000 people were evaluated for the trial with 220 patients treated at different doses and 56 patients in an untreated control group. Note that this trial was not intended to evaluate efficacy. It was not "powered" for efficacy. Efficacy is monitored in larger "Phase III" trials - typically 900 people. Since we didn't have that number of patients, we can't say, overall, " this worked ".   Equally, it is not possible to say " this didn't work". Scientifically, it is simply not valid to draw conclusions on efficacy from a trial of this size, unless results are really striking.  

Patient receiving a blood test

The trial showed that patients' viable lymphocytes (functioning T cells) significantly increased and programmed cell death (‘apoptosis’) decreased.

Strong results were found in relation to reduction of apoptosis; the increase in viable lymphocytes; the reduction in death, hospitalisation and increase in time before needing to use anti-retrovirals. In relation to viral load and CD4 count the results were not statistically significant : we can't make meaningful scientiific conclusions - for that, greater numbers are needed. We would like to do a large scale Phase III trial - and we would love the resources to do it!

Between September 2010, and November 2011 we have treated around 1,100 people, outside formal clinical trials. Their results give us confidence to keep pressing on,

A recent large scale study carried out by Case Western Reserve University in the U.S.A., has confirmed that viral load is not an accurate measure of HIV’s progression to AIDS. ³ This study was conducted on 2,800 patients over three centres, and it should be taken seriously.

There are many publications about apoptosis being the primary contributor to HIV’s progression to AIDS.  Excerpts from two significant articles are provided below. 

“There is now overwhelming evidence that the primary basis of T cell depletion in HIV positive patients is APOPTOSIS in CD4 and CD8. Badley et.al. Blood, 2000”

 “The major mechanism of T cell depletion is programmed cell death (apoptosis) which can be induced by HIV through multiple pathways…..as a result of HIV proteins (Tat, gp120, Nef, Vpu)….…One of the ultimate goals of research in this field is to prevent or minimize death in Th cells. If this were achieved it may be possible to convert HIV infection from a progressively immunosuppressive and ultimately fatal disease to a chronic manageable infection.’ Mechanisms of CD4+ T lymphocyte cell death in human immunodeficiency virus infection and AIDS, Alimonti et al, A. JVG, 2002”

Patients receiving treatment

The University of KwaZulu Natal could not evaluate how the virus had been damaged and this remains to be done, using  sophisticated equipment.  We are hoping that an American University will take on this task. Live culture studies have been done on TB bacteria in the US. These studies showed that bacteria treated with the device reproduced at a rate 98% lower than untreated TB (control samples).

There is a single published paper concerning one of the studies carried out by the University of KwaZulu Natal (an animal study).⁴ Normally, we would expect several papers to come out of a trial of this size and importance, and we are still hoping that the University of KZN will decide to publish the results of its findings. The lack of papers may reflect an embargo on publication imposed by the former South African administration.  As  more trials are carried out, we hope for full publication of results.

Excerpts from Clinical Trial Reports

In-vitro trials

Excerpt from 

Historical Research on EMFS (1992-2002)

• In-vitro studies performed by Dr. Edward V. Karamov, Director of Immunochemistry, Academy of Medical Sciences, Ivanofsky Institute of Virology 1992-1993. ___
• In-vivo studies performed by Dr. Edward V. Karamov, WHO Collaborating Centre on AIDS, Academy of Medical Sciences, Ivanofsky Institute of Virology 1992-1994. ___
• Animal Studies publication on Effects of Electromagnetic Field on Experimental Abnormalities in Amphibian Development, Savel’jev et al, Biull Eksp in BIOL MED Feb 1994 117(2);182-5. ____
• In-vitro studies performed in 1996-1998 by Professor Abraham Karpas, Assistant Director of Research, Department of Haematology, University of Cambridge. __
• In-vitro studies performed in 2000-2001 by Professor George Berensci, Head of Division of Virology, Hungary National Centre of Epidemiology.
• Retrospective Study report on the Safety & Efficacy of Electromagnetic Frequency Resonance in Adult Patients infected with HIV. Performed by Nelson R Mandela School of Medicine, University of KwaZulu-Natal in 2002. ____
• Phase I / II Dose-ranging Study of Electromagnetic Frequency Resonance in Adult Patients infected with HIV. Performed by Nelson R Mandela School of Medicine, University of KwaZulu-Natal in 2004-5

³ Predictive Value of Plasma HIV RNA Level on Rate of CD4 T Cell
Decline in Untreated HIV infection, Benigno Rodríguez, MD Center for AIDS Research at University Hospitals Case Medical Center published September 2006 Journal of the American Mediacl Association