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ISIS Report 03/04/04
"Pink Panacea", at last a vaccine against AIDS?
Sam Burcher reports on an unconventional
vaccine that could provide treatment for AIDS
A fully referenced
version of this report is posted on ISIS
member's website. Full details here
A company based in Thailand has developed an oral vaccine against HIV/AIDS.
The makers of a pink pill called "V1"; claim striking success in
the treatment of HIV/AIDS symptoms .
Immunitor Corporation Company and V1's creators are clinical researcher Dr
Aldar S. Bourinbaiar and pharmacist Vichai Jirathitikal who have put V1 through
a placebo-controlled phase II study. The results showed significant improvements
in CD4 and CD8 cell counts, weight gain, decreased viral load and survival of
end-stage AIDS patients. It also suggested that the V1 could reverse the progression
of AIDS without concurrent toxicity .
Immunitor and Dr Orapun Metadilogkul, an independent physician who heads the
Thailand Association of Occupational and Environmental Medicine Physicians,
claim that 27 patients diagnosed with HIV/AIDS have seroconverted from HIV positive
to HIV negative after treatment with V1. A phase III trial application has been
submitted to the Thai Food and Drug Administration (FDA) aimed at demonstrating
the beneficial properties of V1 on associated symptoms of AIDS such as wasting.
If approved, trials will take place at the largest public hospital in Bangkok
under Dr Metadilogkul.
V1 is said to be a therapeutic vaccine comprising "HIV antigens from pooled
clinical isolates from HIV infected donors". These antigens are made into pills
taken orally that do not degrade in the digestion process of the stomach, but
trigger immune responses in the underlying mucosa-associated immune cells in
the lining of the small intestine.
Some 90% of the immune cells in the human body are made up of lymphocytes and
monocytes in the lining of the mucosal surfaces. So there are ten times more
CD4 and CD8 lymphocytes residing in the mucosal lining than in the blood where
only 2% of lymphocytes are present. According to Immunitor, these intestinal
cells are the front-line defence against HIV and are the first to be destroyed
or disabled by the virus.
Once mucosal immunity has failed, the common and often fatal symptoms of HIV/AIDS
appear, such as diarrhoea and respiratory infections. V1 works on the premise
that HIV/AIDS is a disease of mucosal immunity, so targeting antigens at mucosal
surfaces is a valid clinical approach.
Public opinion on V1 came sharply into focus when Thai clinics began giving
out the pink pills free of charge to AIDS patients at mass rallies organised
in schools, police stations, sport stadiums and Buddhist temples. There was
opposition to these actions by a number of workers in conventional medical practices,
despite the fact that they have no effective treatment to offer to patients
V1 is extensively subject to toxicity studies both in vitro and in vivo. So
far, studies by the Thai government and independent private laboratories have
proved it exhibits no toxicity. Five mammalian cell lines tested at the highest
dose of 10mg/ml showed no sign of cytotoxicity. The extrapolated dose of V1
that would cause death in humans is 2 200 pills per day, as against the recommended
daily dose for adults of one or two pills per day.
Recently published data from Immunitor shows that 40 AIDS patients on a six
month trial of V1 treatment increased their CD4 and CD8 cells counts by a mean
average of 51 cells (19%) per microlitre of blood. Increase in body weight was
2.2 kg on average. But some patients'weight increased by as much as 30
kg, which is an important gain in the treatment of AIDS.
These encouraging results led Bourinbaiar and Jirathitikal to evaluate V1 therapy
in the treatment of terminally ill AIDS patients in intensive care wards in
Thai hospitals. They approached 117 patients and 53 decided to take V1 while
64 declined treatment. All patients were bedridden and had been receiving palliative
care. None of the patients had access to conventional anti-retroviral drugs,
but some had been treated with antibiotics. All the patients in the non-V1 group
were dead by week 9. In contrast 30 out of the 53 in the V1 group were alive
and able to resume normal activity.
After 20 months on V1, 18% of patients who started with almost zero CD4 counts
were still alive. It was also noted that patients receiving V1 seldom developed
opportunistic infections, which further suggests that V1 improves mucosal immune
responses to infections.
A retrospective analysis by Bourinbaiar and Jirathitikal of 650 HIV positive
patients who had taken V1 for an average of twenty-three weeks showed significant
results. In total, 496 (76%) were able to increase their body weight or at least
maintain weight on the V1 regime; 389 (59%) gained 4.2 kg, while 107 (17%) remained
unchanged and 159 (24%) lost weight. Everyone participating in the trial was
able remain on it and suffered no serious side effects .
A further study took place whereby V1 was administered to the HIV-negative
relatives of terminally ill AIDS patients over a median period of twenty-four
days. Their blood was then transfused into the AIDS patients who experienced
an improvement in their health. Results showed that increases in CD4 and CD8
counts were statistically significant .
V1 is currently licensed as a food supplement by the Thai Food and Drug Federation
(FDA) and is produced for R&D purposes. A one months supply costs around
$20-£30 per person, but it is given freely to poor patients in public
hospitals wherever possible. So far 65 000 Thais infected with HIV have been
given the treatment.
Costs for V1 contrast strikingly with those of more established combination
therapies or "cocktails" consisting of three-drug antiretroviral
treatments of HIV/AIDS. A recent HIV Cost Services Utilization Study Consortium
Analysis estimates that in the USA, 33 500 HIV infected adults seen twice a
year for medications and blood tests spend $6.7 billion or $22 000 per patient
per year .
Apart from the economic viability of V1, there may be other advantages when
considering its use as a safe therapy for the developing world. It has broad-spectrum
activity against many HIV subtypes and is stable in ambient tropical temperatures
for three years, making refrigeration unnecessary. And no special skills or
syringes are needed to administer the pill .
Immunitor is not disclosing the medicinal properties of V1, but instead recommend
a cocktail of V1 and certain generic drugs as alternative and inexpensive treatments
for HIV/AIDS. They cite examples of five compounds: gramicidin (the first antibiotic
to be isolated), cimetidine (Tagamet), warfarin, (a common anti-coagulant),
levamisole (an animal de-wormer), originally developed for animal use, but latterly
became a useful drug in treating colon cancer in humans, and acetaminophen (Paracetamol).
Immunitor says these unapproved drugs are all highly effective against HIV/AIDS
and are incredibly cheap in comparison to approved combination therapies .
(See Alternative AIDS Therapy from Cheap Generics, this series)
Clinical trials of V1 are ongoing and phase III trials are scheduled for Africa
with results pending. It is registered in Ghana and licenses have been applied
for in several other African states. Immunitor hopes to build a vaccine plant
to supply large amounts of V1 to Africans at low cost. This would meet a critical
demand for affordable and available HIV/AIDS treatment in the Continent.
Much attention is centred on the high rates of infection and death, 95%, caused
by HIV/AIDS in the developing world. But until recently the intimate association
between the pandemic and poverty has been played down in the application of
strategic approaches for HIV/AIDS. In his recent letter to The Times newspaper
Prof. Kenneth Stuart, the medical advisor to the Commonwealth Secretariat, highlighted
the need to recognise the role of poverty in effective treatments for HIV/AIDS.
He says "The more the gap widen between rich and poor the greater the number
of people who are left stranded in the backwaters of progress." So not only
are people in poverty traps deprived access to helpful technologies and medicines
their ability to acquire knowledge is diminished along with their human rights
The report "Thailand Social Monitor: Poverty and Public Policy" says
16 per cent of the country's population, or about 10 million people, are now
living on less than the minimal income of Bt900 per person per month, which
constitutes the country's poverty line .
"Poverty is re-emerging as one of the nation's most serious problems," said
Ian Porter, the World Bank's country director for Thailand at the launch of
the new report, which was jointly prepared by the National Economic and Social
Development Board, the Thailand Development Research Institute and international
experts .An international AIDS conference will be held in Bangkok in July