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I am writing this from Chennai. I was here to attend 3rd International Conference on AIDS (2nd to 5th December 2001). There was a special satellite session on MICROBICIDES and we mentioned the M-POWER column in SAWF. Delegates were amazed and the URL of this website was flashed in the presentation ofcourse. Below is a detailed report of three keynote speakers in this session, Dr. Alan Stone from MEdical Research Council, UK, Dr. Gita Ramjee, from Medical Research Council, South Africa and Dr. N.M. Samuel, Chair of AIDS Resource Center, Dr. MGR Medical University, Chennai India.

All of these presentations deal with some specific issues related to Microbicides, and the presentation of Dr. Samuel also threw light upon the acceptability study of microbicides in Namakkal district in Tamil Nadu (an ICMR study).

Ethical issues related to microbicide trials were effectively dealt by Dr. Gita Ramjee, and Dr. Alan STone was no doubt an impressive speaker.

There were several remarkable responses from the audience, and some of them are mentioned below at the end of the document.

Warm regards
Bobby Ramakant

Chennai Dec 9, 2001 - "Namakkal, is primed for microbicide research and acceptability study" said Dr.N.M. Samuel

< -- From the left. Prof. Dr. NM Samuel with Dr. Uton Muchtar Rafaei, Regional Director, WHO, New Delhi at the inaugural funtion on Dec 1st.

        An exclusive satellite session on Microbicides, was held today at AIDS INDIA 2000 conference, Chennai, India, in the main conference auditorium (Maurya Hall). It was largely attended by delegates and got impressive response from researchers, microbiologists, policy makers, and NGO sector in India.

         Dr. Alan Stone, from Medical Research Council, UK, and Dr. Gita Ramjee, from Medical Research Council in Durban, South AFrica, were the co-chairs of this session.

         Dr.N.M.Samuel, Professor and Head, of Experimental Medicine and AIDS Resource Center, Dr. MGR Medical University, Chennai, moderated the discussion.

        Dr. Samuel remarked that 'Microbicides is a new area for India and therefore it is important to give it a focus here at this congress. He also said that this is the prime reason to select two experts (Dr.Alan Stone and Dr.Gita Ramjee) - one each from a developed and a developing country - to have a better understanding of the entire issue and the relevance of Microbicides in Indian context.

         Dr.Samuel spoke on "Do Women need Microbicides?". He started his talk by bringing out starkly the vulnerability and risk factor Indian women are facing to contract sexually transmitted infections including HIV/AIDS. He said that over 20 million births happen in India every year, and 1-4 % seropositiveness is found in pregnant women in different states. This indicates that the number of infants who become seropositive at birth, is increasing. He quoted a study that with AZT to pregnant positive women, there were 1 in 12 births of positive infants, and without AZT, the number of positive infants were : 3 in 12.

         He said that only 59% of women come to collect the results of HIV tests. Drug affordability and accessibility continue to remain potent issues. 43 % women give birth at home in India or delivery is managed by trained/ untrained midwives.

         Dr. Samuel said that Dr. MGR Medical University conducted a study at Namakkal, a small district 400 kilometers away from Chennai. He said that counseling the pregnant women at Ante-natal clinic was the most important factor. Maintaining confidentiality was another significant reason that came forward in his experience at Namakkal. 92.5 % women responded "NO" to a survey question that "Will your husband discuss the use of condom with you?". However 91% women responded "YES" to the question that will they use a protective cream if given, to prevent sexually transmitted infections including HIV, and pregnancies.

         Dr.Samuel said that this is an important indicator to community preparedness in India to products like Microbicides.

         Dr.Samuel said that his Namakkal experience brought out several learning lessons that included the need for primary prevention of infection, behavioural modification of both : men and women, challenges in seeking informed consents (female autonomy, role of the husband), and also the role of the community, local authority, health ministry and big pharmaceuticals. He said pricing microbicides may be another area of high concern in India.

         "Namakkal, is primed for microbicide research and acceptability study", were his concluding remarks.

"First Microbicides may hit the market by 2006-2007" said Dr.Alan Stone

         Dr. Alan Stone, from Medical Research Council, UK, spoke on "Microbicides and their role in HIV Prevention" at this special satellite session on Microbicides at AIDS INDIA 2000, in Chennai, India, today.

         Dr.Alan Stone started his presentation with "WHO said, no safe and effective microbicides yet in the market" and re-framed the verse in an extremely positive manner to "we already have developed several highly promising product leads (half a dozen formulations), all of which have tested non-toxic too".

         Bringing out the vulnerability of women, Dr. Alan Stone said that 5.3 million new infections occurred in the year 2000 (source :UNAIDS) and half of them, were in women. In India, (source UNAIDS), Dr. Alan Stone said that out of total 5.3 million HIV positive people in 1999, 1.3 million were women.

        STD clinics in Mumbai and Delhi noticed sharp rise in their cases in past decade (64 %).

        Addressing an important querry that "why do we need microbicides when effective options like male condoms are there", Dr. Alan Stone said that condoms are characterized by being male controlled options and providing good protection against a broad range of sexually transmitted infections including HIV/AIDS. However use of condom is inconsistent because they reduce sexual pleasure, reduce spontaneity, question level of trust between partners, and challenge the accepted power relationships when a woman asks a man to put a condom, and in couples attempting to conceive a child, it prevents child bearing.

         Microbicides on the contrary, are female controlled prevention options, requiring NO negotiation with partners, they are not a physical barrier to sexual pleasure, they don't interrupt the natural course of events during sexual intercourse (microbicides are applied much before coitus), they widen the range of safer sex choices, and microbicides are not necessarily contraceptive.

         He also commended the formation of International Working Group on Microbicides, which encompassed all the key players from WHO to local agencies like AIDS Resource Center at Dr. MGR Medical University in Chennai (represented by Dr. NM Samuel).

         Commenting on the need to have microbicides which must not damage the natural defense system of vagina, he said that internal vaginal wall is naturally an excellent barrier to Sexually Transmitted infections including HIV/AIDS.

         Dr. Alan Stone marked the 'obligatory requirements' of having a safe and effective microbicides, and said that it should be highly active against free and cell associated HIV. It should be active against a range of HIV strains and sub-types. It should also be effective in presence of semen, because majority of HIV transmission occurs in presence of semen. They should have a low cyto-toxicity in vitro. They must be non-mutagenic in standard tests and stable too. Their compatibility with latex is also mandatory. And above all, microbicide product leads must be non-toxic in vitro too.

         Enumerating the preferable characteristics, Dr.Stone remarked that microbicide product leads should not have any activity against lacto-bacilli, there should be no systemic absorption, color, odour and taste of microbicides must not be offensive, their effectivity should be broad spectrum spanning over a range of sexually transmitted infections including HIV, affordability remains an important issue and their availability in different formulations is also vital for larger reach.

         Bringing another issue in the forefront, Dr. Alan Stone quoted the UNAIDS report 2000 that "Non-oxynol 9 (N-9), actually increased HIV acquisition". He said that these trials were disappointing because they were largely held in sex workers' community (where frequency of sexual intercourse is higher) and lesions once formed inside vagina, may take upto 2-3 days to heal.

         However N-9 no longer remains the product lead for microbicides, and thereafter, microbicide research has come up with several promising product leads (more than a dozen) with different mechanisms of action like Anti-Retro Virals (ARVs), surfactants, sulphonated polymers, natural extracts, etc.

         There is no side effect reported in these current product leads however clinical trials are still going on. Microbicide research is going on two parallel tracks : one is on currently available product leads, and the other is in basic research laboratories where new understanding of HIV transmission and acquisition, is opening up new vistas of second and third generation of product leads for microbicide research and development.

         Dr. Alan Stone concluded on an extremely positive note and said that "First Microbicide may hit the market by 2006-2007 - which will be a low cost, broad spectrum, self-administered, female controlled option to prevent transmission of STIs including HIV/AIDS. And this will be no magic bullet, rather will widen the range of existing options to prevent HIV transmission".

Three Microbicide - product leads to enter Phase III trials soon - says Dr.Gita Ramjee

Prof. Dr. Samuel along with Dr. Gita Ramjee from South Africa at the Microbicide Satelite session. -- >

        Dr.Gita Ramjee, from Medical Research Council in Durban, South Africa, spoke on "Vaginal Microbicides - Clinical Trials, Ethics, and Acceptability" at today's special satellite session on Microbicides, in AIDS INDIA 2000 conference going on in Chennai, India.

         Dr. Gita Ramjee explained in detail the various Phases I, IIa and IIb, IIIa and IIIb, and IV in a clinical trial. Stating that phase I, focuses on the initial safety trials, phase IIa is a pilot clinical trial, to evaluate efficacy and safety both, phase IIb is a pivotal trial and is well controlled too being the most rigorous demonstration of efficacy, Phase IIIa is conducted in the target population and Phase IIIb deals with quality of life and marketing issues. Phase IV focuses on issues that arise once the product is marketed and is based on observation or experience of target population.

        In Pre Clinical phase, Microbicides have 14 product leads currently. There are SIX product leads that have completed Phase I trials - cellulose sulphate, PMPA, PSS, CSIG, Acidiform, DS. Three product leads of microbicides have completed Phase II trials and include Carraguard, Lactobacillus crispatus, PRO 2000, and Phase III trials on them will commence soon. Only two products had undergone phase III before and they were Non-Oxynol -9 based products (conceptrol and advantage 24), and it has been proven that N-9 increases the risk of HIV acquisition, so Microbicide research continued on other promising product leads and the three product leads to clear Phase II trials will soon enter Phase III trials, said Dr.Ramjee.

         Bringing in the issue of Ethics in Microbicide research and development, Dr.Gita Ramjee commented that in Vaginal Microbicide - COL 1492 study, several potent ethical concerns came to the forefront. Exclusion of HIV positive women from the study, care and support available to HIV seroconverters, and the process of obtaining informed consent, were the main ethical issues that came into limelight in this study.

         This COL 1492 study was done on 477 sex workers, and 20% of them were illiterate. Maintaining confidentiality was also critical, and HIV positive women were separately counseled and trained to come up with convincing reasons when asked by their community people for not participating in this study.

         In Durban, women who sero-converted during the trials were provided routine standard of care and treatment but no ARV was given to any of them. And in Abidjan, besides routine standard of care and treatment made available to sero-converters, ARV was also provided to them.

         Commenting on "Informed Consent", Dr.Gita Ramjee said that in Durban 70% of women had a very poor understanding of study objectives and 98% of women had a poor understanding of potential effects and risks involved. When this came into light, the action taken in Durban, were to increase condom counseling and reiterate study objectives at every follow up.

         In Cotonou, 45 % of women undergoing trials, had a very poor understanding of gel + condom use, and 75% women had NO understanding of 'placebo'.

         Dr. Gita Ramjee categorically stated that "Informed Consent" is an ongoing process certainly, and there is a pressing need for repeated verification, monitoring (by outside agency), and reiteration at every available opportunity.

         She said that sensitivity to cultural and moral values and building respectful relationships between research community and women undergoing trials, and a higher quality of research, are the other significant concerns that came out during COL 1492 study.

         Dr. Ramjee said that there were many positive outcomes too of this study, including individual development of women undergoing trials, contrary to those who didn't participated in these trials, and noticeable increase of self-esteem in these women.

         Dr. Gita Ramjee remarked that visible 'altruism' was also an important indicator in most of the participants of this study as they were not disappointed by the research outcome of this study and were willing to participate in future trials for an effective female controlled prevention option.

         Dr. Gita Ramjee commented very strongly on the need to prepare for adverse trial outcomes before the trial begins.

         Dr. Gita Ramjee addressed another important issue related to microbicide research and development, and that is of ACCEPTABILITY study. She said that acceptability studies have to go alongside research and development. She said that acceptability studies have shown that a potential microbicide must address issues related to following product features :lubrication, types of formulation, insertion and aesthetic appeal. It should also address issues related to social aspect : impact on condom usage, and role of men. And lastly, she said that microbicides must also address issues related to provider's influence : promotion of product and counseling.

         Wrapping up her elaborate presentation, Dr. Gita Ramjee said that there is no doubt about the compelling need for female controlled HIV prevention intervention. She repeated that complex ethical issues can only be resolved if developing countries in particular can come up with their own guidelines, and researchers, community, and service providers work together (and not in isolation).

        Dr. V.K.Vinayak, Medical Advisor in Department of Biotechnology, Ministry of Science and Technology, Government of India, commented that Government of India is already in the process of constituting a national working group on microbicides. Dr.Vinayak added that Indian Council of Medical Research ICMR has already come up with an extremely comprehensive guidelines on ethical considerations, and therefore no further debate should be done on the issue of ethics and ICMR guidelines be followed.

        The response of those who attended this session, was positive, and Dr.Aruna, Professor and Head of Department of Microbiology, Gandhi Medical College, Hyderabad said that she herself wants to follow microbicide research and is willing to conduct it in her department. Dr.K.Raghupathi, a Ph.D. Scholar at National Institute of Pharmaceutical Education and Research (NIPER), said that 'only for this 90 minutes session on Microbicides' he had come to this conference, and he is satisfied enough to devote his Ph.D. topic on microbicides.

        Dorothy Bray, director Clinical Development, HIV Clinical Development Product Strategy, Glaxo SmithKline, UK, said that she is very much interested into microbicides and her division at GlaxoSmithkline will devote a large amount of grant to Microbicides 2002 conference coming up in Antwerp, Belgium (May 2002). She said that she will also propose to Glaxo Smithkline to be a co-sponsor of Global Campaign for Prevention Options for Women.

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