Progress in Therapeutic AIDS Vaccine Research.

[Guest guest]

[Moderators note: There is ample preliminary evidence to indicate

that a " Therapeutic AIDS Vaccine is feasible. India has an added

urgency to explore the potential of a `Therapeutic AIDS Vaccine' as

it would address the treatment needs of people living with HIV/AIDS,

and further contribute to health equity in India. ICMR's Exclusive

deal on `Preventive AIDS Vaccine research' will compromise the best

interest of the country. It appears that, some of the well meaning

Indian AIDS NGOs are being taken for a ride by the Prevention only

AIDS Vaccine Advocates.

http://www.issuesinmedicalethics.org/123vp087.html .Time for NACO

to develop an Independent AIDS Vaccine Policy, incorporating a

Therapeutic AIDS Vaccine research strategy]

Researchers hopeful over anti-AIDS patch

By Logan Aug 3, 2006, 15:38 GMT

Budapest - Patches have been used for years to help smokers kick the

habit. Now a team of Hungarian and US researchers is looking to use

the same technology to deliver a vaccine against HIV/AIDS by as

early as 2009.

Genetic Immunity, the company developing the vaccine, has just

completed the first safety trials on humans in the Szent Laszlo

hospital in Budapest, clearing the way for more clinical trials on

the actual efficiency of the vaccine.

'The first trial was carried out on nine people,' the CEO of Genetic

Immunity's Hungarian arm, Zsolt Lisziewicz, told Deutsche Presse-

Agentur dpa. 'The goal was to check the safety and toxicity of the

vaccine. We didn't find any side effects.'

The next step is to prove that the vaccine patch, named DermaVir,

can work as well on humans as it did on monkeys during an earlier

trial.

Human trials in Sweden, the US and other European countries are set

to being in September, with results expected in 2008.

According to Lisziewicz, the vaccine operates by training the

patient's immune system to suppress the HIV virus, as opposed to the

traditional antiretroviral drugs' method of targeting the virus

directly.

While the vaccine is not designed to prevent the spread of HIV/AIDS

or cure the disease completely, the researchers believe it could be

used to prevent full-blown AIDS ever developing.

'If we can keep the viral load down, the quality of life of HIV

suffers will be increased,' Lisziewicz said.

Hungarian scientist nna Lisziewicz has been leading the vaccine

development in the US since 1996, and the monkey trials seemed to

show great results.

'The very first trial we did was with late-AIDS monkeys that were

expected to live for only two weeks,' Lisziewicz said. 'They

survived for over a year.'

However, he said that the animal trials showed that if the disease

was caught early enough, the immune system could be trained to

almost completely suppress the virus.

'The goal was to suppress the viral load and in the best monkeys we

did this to almost under the level of recognition,' he said.

The clinical trial found that rhesus macaques infected with HIV who

were treated with a combination of DermaVir and antiretroviral drugs

saw their median viral load fall from 33,860 copies/ml to less than

200 copies/ml.

Average viral load of the monkeys with AIDS that were treated with

the same combination fell from over 4 million to less than 200.

Monkeys that did not receive DermoVir showed no drop in viral load.

The delivery system through a patch is also something that the

company feels could be of major benefit due to its simple nature.

'With the patch you don't need to use needles, which can be

dangerous garbage after use,' Lisziewicz said. 'In Africa and Asia

it is difficult to control reuse of needles because the

infrastructure is not so developed.'

The researchers believe that based on their preliminary data the

treatment would consist of applying the patch to a patient's back

for a two-hour period six times a year.

Despite the fact that the trials on the monkeys also used

antiretroviral drugs, the researchers hope the patch could also

eliminate the need to take a daily concoction of pills.

'Our realistic objective today is to treat people with HIV without

[antiretroviral] drugs,' said Lisziewicz. 'If we give them DermaVir,

they will probably never need drug treatment.'

Antiretrovirals, which slow down the spread of the HIV virus, need

to be taken in combination and this can mean taking many different

types of pills throughout the day.

However, there is still a long way to go before anyone can get too

excited, and outside observers remain guarded.

A spokesman for The World Health Organization's HIV/AIDS department

declined to comment, saying that the research was in too early a

phase, with little information on efficacy and/or the safety of the

trials.

However, he said that immune-based therapy could be a promising

therapeutic area in the future for HIV and many other infectious

diseases.

Nonetheless, Genetic Immunity believes it is on the right track, and

hopes to have some kind of limited production in Hungary by 2009.

'Phase 2 clinical trials are expected to finish next year. If we get

a good toxicity profile and acceptable efficacy, we hope to receive

limited marketing approval,' Lisziewicz said.

'We then do Phase 3 and we hope to have the patch ready not much

later than 2009, although this is the most optimistic and assumes

the next two trials will go well,' he continued.

© 2006 dpa - Deutsche Presse-Agentur

http://news.monstersandcritics.com/health/article_1186678.php/Researc

hers_hopeful_over_anti-AIDS_patch