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What
is HIV?
HIV (human immunodeficiency
virus) is the name of the virus that causes AIDS. Scientists
have identifed the virus as a ‹retrovirus,Š which is a virus
in a very specific family of viruses. This virus is passed
from one person to another through blood-to-blood and sexual
contact. In addition, infected pregnant women can pass HIV
to their babies during pregnancy, delivery, or breast-feeding.
How
is HIV contracted?
HIV is transmitted through the passage of body fluids from
an infected person to an uninfected person.
- Blood (such as sharing needles with an injection drug user
who is HIV infected)
- Semen
- Vaginal fluid
- Breast milk
- Other body fluids containing
blood
How
is HIV infection prevented?
Safer sex (male and female condoms, non penetrative sex)
- Clean needle use
- Abstinence
- Use of HIV medications during pregnancy
- Avoidance of breast feeding by HIV infected mothers
Why
we need new HIV prevention tools?
Despite the fact that we know how
to prevent HIV, infections rates continue to increase. What
are some reasons for increasing HIV infections despite known
methods of prevention? Why donât we always use condoms or
clean needles? (IF LEADING A DISCUSSION, ASK FOR RESPONSES
FROM AUDIENCE.)
- Desire for pregnancy
-
Desire for intimacy
- Forced intimacy
- Faith-based opposition
to condoms
- Lack of a clean needle
- Etc
We
need alternative HIV prevention methods that will address
some of the gaps in safer sex and injection drug use behavior.
One new method under research is an HIV microbicide.
An HIV microbicide would provide a user-controlled method
of prevention independent of partner acceptance.
What
is an HIV microbicide?
A "microbicide" is any
substance that can substantially reduce transmission of one
or more sexually transmitted diseases (STDs) when applied
either in the vagina or rectum. Like todayâs spermicides,
a microbicide could be produced in many forms, including gels,
creams, suppositories, films, lubes or in the form of a sponge
or a vaginal ring that slowly releases the active ingredient
over time.
How
do HIV microbicides work?
Scientists are exploring different
approaches to microbicide development. Among these are substances
that:
1-
kill or otherwise immobilize STD pathogens, including HIV
2-
block infection by creating a barrier between the pathogen
and the vagina or rectum
3- prevent the infection
from taking hold after it has entered the body.
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How
are HIV microbicides tested?
Potential microbicide products are
first tested in the laboratory and in animal models. If these
tests show that the substance appears to be safe and shows some
ability to protect against HIV, the next step is to try the
substances in humans.
Human
subject trials proceed through 4 phases:
Phase
I -
few participants, safety is main objective
Phase
II -
more participants, safety and immune response are measured
Phase
III -
hundreds to thousands of participants, safety and effectiveness
in HIV prevention are assessed
Phase
IV - thousands
to tens of thousands of participants, post FDA approval, safety
and effectiveness in widespread use.
Status
of HIV microbicide research
Numerous phase I trials and a handful
of phase II trials have been conducted with potential HIV
microbicide products. There has never been a phase III trial
of a microbicide product.
Would
a microbicide eliminate the need for condoms?
No. When used consistently
and correctly, condoms are likely to provide better protection
against HIV and STDs, so they will still be the preferred
option. But for people who cannot or will not use a condom,
and particularly for people whose partners refuse condoms,
using microbicides can save lives and have a substantial impact
on the epidemic.
Community
issues
Microbicide trials need community
members to enroll. These trial volunteers need initial and
on-going education to understand microbicide research and
the particulars about the trial they are joining. Study staff
are trained and are ethically bound to provide thorough education.
Beyond
study staff, trial volunteers need knowledgeable community
advisors and representatives. Community leaders/representatives
are needed to learn about microbicide research and to reach
out within their community to educate others.
Finally,
community activists are needed to continue to safeguard the
interests of trial volunteers and to advocate for funding
to conduct microbicide research. An effective microbicide
could be identified within 5 years with adequate funding and
well implemented clinical trials.
Questions
for audience
How best do we reach at-risk communities
regarding HIV microbicide research?
How do we overcome distrust of the
medical community and research in adults?
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ONGOING
STUDIES 
