Report by Kadiri Audu
IRMA Steering Committee member
HIV/AIDS Support group 32 people
Sex workers 20 people
Health workers 9 people
Total 61 people
Aim: To create awareness about Microbicides Development and to encourage the participants to get involved in the process.
Analysis: Questionaires were administered at the event to estimate the level of awareness of participants about Microbicides Development.
o 57% of the participants have never heard about Microbicides.
o 15% heard about it but require more information
o 15% heard about it but do not know what it is or how it works.
o While 13% are familiar with Microbicides development.
Some of the questions asked at the event were:
o When would Microbicides likely to be available?
o How much would it cost?
o Would it be supplied for free?
o How are trial volunteers recruited?
o What if I want to volunteer?
Outcome: The outcome was quite encouraging because all the participants showed a level of understanding and 38 people joined IRMA NIGERIA.
Presentation: The paper presented at the event is below.
ORGANISED BY IRMA NIGERIA
WHAT IS MICROBICIDES?
Microbicides are products that could be applied vaginally and that would reduce the transmission of HIV during sexual intercourse. A Microbicides could take the form of a gel, film, suppository, sponge, cream, vaginal ring or other delivery method that releases the active ingredient gradually.
THE NEED FOR MICROBICIDES:
Giving women power over AIDS. The power for women to enjoy safe sex, without negotiating with a sex partner.
KEY ISSUES IN MICROBICIDES DEVELOPMENT:
• Timing – if the handfuls of Microbicides candidates that are currently in advanced clinical trials prove to be effective, a Microbicides could be ready by the end of 2010.
Drug development generally, is a long and complicated process. It takes 10 – 15 years between discovery of a promising lead and its availability on the market.
• Many candidates fail before one ever proves both safe and effective.
• The development stage needs many different candidates which use different mechanisms of action.
MAKING MICROBICIDES AVAILABLE TO PEOPLE LIVING IN THE DEVELOPING WORLD:
• The Microbicides field is committed to making the product available to firstly, those who need them most.
• Public sector developers and advocates are working hard to ensure that innovative vaccines and Microbicides will be accessible and affordable to the people who need them most.
• It is possible that Microbicides would be licensed first in a country where HIV prevalence rate is high rather than countries with low risk.
NATURE OF CLINICAL TRIALS:
• Pre-clinical trials – This is a stage where identified Microbicides candidates pass through a series of rigorous tests in a laboratory and animals before they are allowed to be tested on human beings.
• Phase I – phase I trials are conducted to determine whether the product is safe if used by a small number of volunteer participants over a few weeks, usually 1-3 weeks with 20 – 30 participants
• Phase II – phase II also test for safety of the product but over a longer period of time and with a larger number of participants; 6-18 months, 200-400 participants
• Phase III – phase III trials measures effectiveness; that is weather or not Microbicides actually works in the course of normal use to prevent HIV and STIs. 1-2 years, thousands of participants are enrolled at this stage.
• Frequently, clinical trials need to be repeated to confirm their result or to test the findings in different population.
• The product must be reviewed and licensed for use by at least one drug regulatory agency.
These are products that could be applied rectally and that would reduce the transmission of HIV during anal intercourse and prevent infection.
THE NEED FOR RECTALMICROBICIDES:
• Vaginal Microbicides might not be safe for rectal use
• There are people who engage in anal sex world over
ISSUES AROUND RECTALMICROBICIDES:
• Human rights
• Rectal safety of vaginal Microbicides