Rectal Microbicides:
The Basics
Date, Location
Your Name
This presentation
Overview of epidemic and prevention
Who is IRMA?
What is a microbicide?
What is a rectal microbicide?
Research and advocacy
Get involved!
Global HIV/AIDS Picture
• 33.2 million people living with HIV/AIDS
• 2.5 million new infections each year
• Women account for about half of all new
• Over 25 million people have died
• About 95% live in developing countries
• About 90% do not know their status
Increased to
34% in 2007
What if we had a complete HIV
Prior to exposure
Point of
behaviour change
•Male and female
condoms and lube
antiretroviral therapy
•Voluntary counselling
and testing
•ART to prevent
perinatal transmission
•Treatment for
•STI screening and
•Clean injecting
•Basic care/nutrition
•Preventive Vaccines
prophylaxis (PEP)
•Prevention for
•Vaginal and rectal
•Education and
behavior change
•Cervical barriers
•Therapeutic vaccines
prophylaxis (PREP)
•Male circumcision
International Rectal Microbicide Advocates
• Network of 600+ advocates, leading
scientists, and policymakers from 6
• Mission: support development of safe,
effective, inexpensive, easy to use rectal
microbicides for all that need them
• Released 2008 report in New Delhi: Less
Silence, More Science: Advocacy to Make
Rectal Microbicides a Reality
What is a microbicide?
• A product applied in the vagina or the rectum that
can offer protection against HIV and other STD
• Formulated as a gel, lubricant, or cream
• A rectal microbicide (RM) might be delivered via
suppository, douche, or an enema
• Still in development – are not available yet!
We need a rectal microbicide that is
Easy to use
Easily accessible (i.e. over the counter)
Available in various forms
(lubes, suppositories, enema, condom
An act of unprotected anal
intercourse is 5 to 80 times
more likely to result in HIV
transmission than an act
of unprotected vaginal
Who needs a rectal microbicide?
All kinds of people are having anal
intercourse (AI)…
AI is common globally
• Prevalence & incidence not well
• Widely practiced among MSM
• Increasingly understood as
relatively common between women
and men
– 10-40% report practicing AI
– Most heterosexual AI unprotected
AI and Women
• In absolute numbers, 7x more
heterosexual women than gay men and
MSM in the US practice receptive AI
(conservative estimate)
• Unprotected AI may be a significant
source of HIV transmission in many
contexts, including those labelled as
“heterosexual epidemics”
AI – Gay men and MSM
• Most HIV infections due to unprotected AI
• In North America, Western Europe, Latin
America :
– Gay men and MSM make up most HIV infections
• In many African, Asian and Latin American
– HIV among MSM significantly higher than general
• Globally, only 9% of MSM in 2006 received
any type of prevention
Challenges to RM Development
Compared to microbicides for vaginal use, RMs are
in much earlier stages of development because
• Scientific and biological challenges
• More complex safety issues – rectum very fragile
• Lack of resources
• Lack of understanding of need
• Political and cultural reluctance to address anal
– Stigma
– Denial
– Homophobia
Biological challenges
Most of the epithelium is 40 cell
layers thick
Very fragile epithelium,
1 cell layer thick.
Fewer CD4 cells than rectum
More inflammatory cells under
(CD4 receptors)
Acidic pH
Alkaline, rather than acidic pH
Enclosed pouch
Open-ended tube
Anatomy 101
• Potential RMs are
tested for safety
• Sexual lubricants
should be tested for
• Microbicides intended
rectal safety
for vaginal use need to
be tested for rectal
RMs: Investments 2000 - 2006
• Total investments
= US$34M
• About US$7M per year
• U.S. public sector contributed 97.4% of
overall funds
• Philanthropic and private sectors 2.6%
RMs: Investments 2000 - 2006
Needs estimate
Conservatively, rectal field
probably needs 5 candidates over
10 – 15 years
Will require minimum US$350M,
or at least $35M/year for 10 years
Therefore, annual spending
needs to increase 5X
RM Research
Baseline studies
Clinical trials
What normally happens during Are these RMs safe?
Acceptability &
Distribution studies behavioural studies
Where do RMs need to go?
What kinds of products would
people use?
Clinical trials
• World’s first rectal microbicide safety trial:
Testing UC-781
– Phase I, randomized, placebo-controlled safety and
acceptability study of vaginal microbicide gel
formulation applied rectally in HIV-1 seronegative
• Part of: National Institute of Health U19
Microbicide Development Program (MDP)
– $17.4 million, ends 2009
• More trials planned: tenofovir, PRO 2000…
Lube survey
IRMA’s 2007 online survey on lube use
for anal sex had nearly 9,000 responses
from over 100 countries, in 6 languages
• Most respondents do not always use
condoms, but many use lube
• RMs similar to existing lubes would
probably be highly acceptable
• Need to consider implications of adding
saliva, vaginal fluid, water to lubes when
testing them
• Microbicide research is not adequately funded
• Need for increased funding for both vaginal and
rectal microbicides
– Talk to funders, policy makers, elected
officials, other government officials
– Recruit researchers to the field of RM
– YOU can be an advocate!
If you have 5-10 minutes you can…
• Read one fact sheet or news item from our
website or our blog
• Sign up for the IRMA listserv through the
• Pass along our web address and
contact information to another
advocate, researcher, policy maker
or potential funder
If you have 30-60 minutes….
• Join one of IRMA’s regular free teleconferences
featuring world leaders in RM research and
- see website for what’s next
• Read an excellent resource from our web site,
including Less Silence, More Science
• Make a presentation and host a discussion with
your colleagues – like this one!
• Talk to members of your community about your
interest in rectal microbicides
To engage actively in shaping the
rectal microbicide field…
• Join an IRMA working groups to help us meet our
• Join IRMA’s Steering Committee
• Become your community’s rectal microbicide
– enlist organisational support
– conduct presentations
– engage the media with support from IRMA
• Reach out to advocates, researchers, policy makers
and funders to ask for their support
Global Campaign for Microbicides
A worldwide effort co-sponsored by groups
working on
• Reproductive health
• Women’s empowerment
• Gay health
Working to educate, raise awareness and
generate collective advocacy for
increased political and public investment
in microbicide development. Partners with
International Rectal Microbicide Advocates
Global Campaign for Microbicides
Alliance for Microbicide Development
amfAR-The Foundation for AIDS Research
Microbicide Trials Network
International Partnership for Microbicides
Thank You
• Your name
• Your organization
• Your email address