In the lats two years, the world had received the results of a
number of HIV prevention trials. Specifically, the following trials
have produced no evidence of effect, or a trend towards harm:

• CONRAD phase III study of cellulose sulphate (UsherCell)
microbicide halted after interim analysis showed higher rate of HIV
infection in UsherCell group (the Family Health International study
of cellulose sulphate, a trial also conducted in Nigeria – was also
halted not because there was harm but due to the fact that the
CONRAD study was stopped).

• MIRA female diaphragm and lubricant study completed, but no
evidence of protective effect.

•HSV-2 suppression therapy which were completed but no evidence of protective effect.

•Population Council phase III study of Carraguard microbicide
completed, but no evidence of protective effect.

•The 0.5% concentration PRO 2000 arm abandoned in the MDP
(Microbicides Development Program) phase III study due to futility

•STEP proof of concept study of Merck’s Ad5 HIV vaccine halted after
interim analysis showed lack of protective effect. There was a
tendency towards more harm

Although these studies have not provided a prevention technology for further development, they have demonstrated the ability of multiple sponsors to run large trials of prevention technologies, and
generated important information that will contribute to the design
of future studies.

The only positive results in the past two years from HIV prevention
phase III trials have come from adult male circumcision studies
which shows that circumcision reduces the rate of HIV infection IF
and WHEN the study site heals at least 6 weeks before commensing
sex. The need and importance of healing was evident from the results of a negative signal observed a study of male circumcision in HIV- positive men which showed a trend towards a higher rate of HIV
infection in sexual partners of circumcised men when compared to
partners of men who were not circumcised.

Has the field failed so far?
In the field of drug development, there are evidence to show that
when 10,000 potential drugs are found to possibly work in the
laboratory, it takes an average of 6.5years for ONLY 250 of these
compounds to show that it can actually do something in animals. Of
the 250 compunds, only 5 makes it through to phase III over a 7 year period. And of the five, only 1 makes it for drug approval after a 1.5year period. On the whole, it takes about 15 years to develop a
product even WHEN all the needed information is available.

The HIV prevention field has so far not deviated from the norm of
drug development even moreso in the light of the many unknown that plaques the research field. All trials have informed the planning
and implementation of the next trial in such a way as to improve the
care and protection of trial participants. The field is also more
responsive to community concern.

Has the field failed so far? The moderator lookd forward to your
sharing your views and perception on this. Happy discussion.