The international Microbicides 2008 Conference in New Delhi

[Guest guest]

[The biannual international Microbicides 2008 Conference is being

held at New Delhi from Sunday February 24th to Wednesday 27th, 2008.

http://www.microbicides2008.com/ ]

The biannual international microbicides conference " Microbicides

2008 " will run 24 – 27 February in New Delhi under the

theme " Striving towards HIV Prevention " .

The gathering will enable knowledge-sharing between microbicide

researchers, public health workers and advocacy organizations and

will provide a forum for the discussion of new developments in

microbicide research including basic science, clinical trials and

social science issues as well as discussion on behaviour, community

engagement and advocacy.

In the second of a two part series looking at microbicides, we will

be exploring some of these topics.

For several years, UNAIDS has insisted that the development of an

effective microbicide is a public health priority and has emphasized

the importance of access and affordability. However due to a lack of

significant investment, the research and development pipeline has

been slow and inefficient.

UNAIDS Executive Director, Dr Piot said, " The international

community, including the private sector, must continue to invest in

effective HIV prevention technologies that can be used by women . "

" Ensuring access to safe and effective microbicides will be of

critical importance to all our prevention efforts and to our goal of

stopping and reversing the epidemic. "

The cost of saving lives

The total global funding for microbicide research and development in

2006 done by the non-commercial sectors was $217 million. The

pharmaceutical sector chooses to invest into the search for new

antiretroviral drugs, attracted by a potentially large return-on-

investment.

If there was comparable investment into microbicide research, it is

thought that a safe and effective product would be on the market much

sooner than a vaccine. However, as any microbicide would have to be

affordable to consumers to whom it would make most difference – women

living in low- and middle-income countries – the profit margins would

be low. This economic reality makes microbicide research a less

attractive investment.

As a consequence virtually all microbicide research is conducted by

small biotech companies funded by the public sector.

Research and development pipeline

Research and development is continuing in spite of the large funding

gap. More investment will be needed to bring clinical trials to

completion and lay groundwork for distribution of an effective

product.

As with any new drug, candidate microbicides must pass a series of

rigorous laboratory tests and then a series of human clinical trials.

What are the different phases of a clinical trial?

Phase I clinical trials are the first stage of testing in humans and

are designed to evaluate safety. Normally the trials are conducted in

an inpatient clinic, where volunteers can be monitored closely. A

group of 20-80 healthy volunteers will use the product for 1–2 weeks.

Once the initial safety of the study drug has been confirmed in Phase

I trials, Phase II trials are performed on larger groups of 20-300

and are designed to assess how well the product works, as well as to

continue safety and tolerability assessments in a larger group of

volunteers over 6–18 months.

When the development process for a new drug fails, this usually

occurs during Phase II trials when the drug is discovered to show no

evidence of potential effect, or found to have toxic effects.

Phase III studies are randomized controlled multi-centre trials on

large groups (300–3,000 or more) and are aimed at being the

definitive assessment of how effective and safe the drug is. Because

of their large size and duration (1–2 years), Phase III trials are

the most expensive, time-consuming and difficult trials to design and

run.

A range of contraceptive and non-contraceptive microbicide products

are currently in different phases of development and trial including

over 30 candidates in clinical trials. More than 30 others are in pre-

clinical testing. However, results to date have been disappointing.

The microbicide search had an unexpected setback in February 2007

when an advanced Phase III study of a candidate microbicide Cellulose

Sulfate was stopped early because women who used the gel were

suspected to have a higher risk of HIV infection compared with women

in the placebo group.

Earlier this week it was announced that Carraguard, a candidate

microbicide that had completed large-scale Phase III trials, was

unable to prevent HIV transmission. Encouragingly the product was

found to be safe for long-term vaginal use making it the first

microbicide Phase III trial to be completed without safety concerns.

Researchers are hopeful this is a finding which will be built on.

" The next generation of antiretroviral-based microbicide products

holds much promise. We do need to develop better safety biomarkers

and improve measurements of adherence and we can learn much more from

trials which have not resulted in an effective product, " said UNAIDS

Chief Scientific Adviser, Dr Hankins.

Timing of microbicide availability

The Global Campaign for Microbicides estimated that if one of the

products in advanced clinical trials proves to be effective, a

microbicide could be ready for distribution in a small number of

countries by the end of 2010. However, if the current sets of

products do not prove effective, the timeline will be longer.

Ethical considerations

Advocates and civil society work hard to ensure that as the science

proceeds, the rights and interests of trial participants and their

communities are protected.

In microbicide trials all women are provided with a comprehensive HIV

prevention package including counselling on condom use and safe sex,

supplies of free, high quality condoms and regular screening for HIV

and other sexually transmitted infections.

Well-run trials are vital to women's positive perception of trial

participation – participants have expressed the importance of having

access to information, being treated with respect, having an

opportunity to be listened to, access to HIV testing and counselling

and access to condoms.

It is also vital that trial designs take into account local social

and community perceptions of HIV, health and sex and that

participants who become HIV-positive during or after the trials have

access to care and support services.

UNAIDS and AVAC have published " Good participatory practice

guidelines for biomedical HIV prevention trials " which sets out ten

principles for community engagement throughout the research life

cycle.

International consensus has been reached and detailed in 1 9 guidance

points on a range of topics including confidentiality, informed

consent, control groups and potential harms, in the recently

published UNAIDS/WHO guidance document " Ethical considerations in

biomedical HIV prevention trials "

Next steps

Next week's Microbicide conference will be an important forum for the

discussion of the challenging issues of research, financing, clinical

trials and ethical considerations.

Experts will gather to hear updates on current and emerging candidate

product trials and will debate a range of topics. UNAIDS Chief

Scientific Adviser Dr Hankins will make presentations on

the implications of the results of male circumcision trials for

microbicide research and present findings from the December 2007

consultation " Making HIV trials work for women and adolescent girls " .

UNAIDS Executive Director Dr Piot will address the conference

closing ceremony which will be attended by politicians, policy-

makers, scientists, community activists and other AIDS experts.

The London School of Hygiene and Tropical Medicine estimated by

mathematical modelling that the introduction of even a 60% effective

microbicide into the world's 73 lowest-income countries which would

be used by only 20% of women already in contact with health services

could avert up to 2.5 million infections in three years.

With many observers confident that a successful microbicide could

make a significant impact in HIV prevention around the globe, the

wait is all the more frustrating, the set-backs all the more

disappointing

http://www.unaids.org/en/KnowledgeCentre/Resources/FeatureStories/arch

ive/2008/20080222-microbicides_Part_2.asp

[Guest guest]

Dear All,

We have several reports about the lack of any ready

candidate microbicide readily available as a part of

the new preventive strategy/methodology including the

latest press report as follows.It necessitates the

need to share the observations,deliberations and

recommendations of the very useful conference which

many of us are unable to participate in person due to

varied reasons:-

Dr. Rajesh Gopal, MD

Joint Director,

Gujarat State AIDS Control Society (GSACS),

O/1 Block, New Mental Hospital Complex,

Meghaninagar, Ahmedabad, Gujarat.

PIN 380016

Phone (O) 079-22680211--12--13,22685210 Fax 079-22680214

e-mail: <dr_rajeshg@...>