IRMA's Jim Pickett provided an update on rectal microbicide research and advocacy at the "Building Healthy Communities by Breaking Down Barriers - 2015 CBO Orientation", presented by Louisiana Department of Health and Hospitals. Presentation was made on Jan 29, 2015. January 29, 2015 – New Orleans

1. The Rectal
Revolution is Here
Jim Pickett
AFC, IRMA
Building Healthy Communities by
Breaking Down Barriers
January 29, 2015 – New Orleans

2. Thank you

3. Thank you
Russell
Brewer
and
Chris Daunis

5. This afternoon
• Showtime
The Rectal Revolution is Here:
An Introduction to Rectal
Microbicide Research
• Rectal microbicide research
– Focus on MTN 017 – first Phase II
– Webinar Feb 11, 2015
• Rectal microbicide advocacy

6. One Rule
The only dumb
question
is the one
you don’t ask

7. 7
tinyurl.com/RectalRevEnglish
tinyurl.com/RectalRevSpanish
tinyurl.com/RectalRevThai youtube.com/IRMAadvocacy

8. 8

9. Showtime…
9

11. 11
tinyurl.com/rectalvid

12. www.hivresourcetracking.org

13. www.hivresourcetracking.org

14. Stages of clinical trials
14
Graphic courtesy International Partnership for Microbicides

15. perspective
15
Of 10,000 compounds that get
tested in the lab, 5 make it to
human trials and 1 makes it to
market.

16. The prevention package
16
 Condoms – male and female
 Condom-compatible lubricant
 Information/education
 Counseling/risk reduction
 HIV testing
 STI testing/treatment
 HEP A and B vaccinations

17. 17

27. 27

28. Condoms work.
So why do we need new strategies to
halt the sexual transmission of HIV?
28

29. Source: Roger Tatoud PhD, Senior Programme Manager, International HIV Clinical Trials Research Mgmt Office,
Imperial College London &
IRMA Steering Committee Member
Here are some reasons for new strategies
29

30. pleasure
intimacy
connection
emotion
love

31. What is the first word or
words that come to your
mind when you think
about PrEP?
Honesty please
31

32. pleasure
intimacy
connection
emotion
love

33. pleasure
intimacy
connection
emotion
love

34. pleasure
intimacy
connection
emotion
love

36. Rectal microbicide research
36

37. First, what is a
microbicide?

39. What is a microbicide?
• A product applied topically in the vagina or the
rectum that can offer protection against HIV and,
ideally, other sexually transmitted infections
• Ideally would have a contraceptive version, and
another to allow for pregnancy – ARV/non-ARV
• Formulated as a gel/lubricant, film, or vaginal ring
• A rectal microbicide might be delivered via
gel/lubricant, douche/enema, or …
Microbicides are still in development
they are not available yet!

40. McGowan I, Biologicals, 2006
Slide courtesy Dr. Ian McGowan
How a microbicide works

41. 41

42. 42

44. Anal intercourse
is a human behavior.

46. An act of unprotected
anal intercourse is 10 to 20 times
more likely to result in HIV
transmission compared to an act
of unprotected vaginal
intercourse.

47. Slide courtesy of the Microbicide Trials Network

48. 48
Ready for some science?

49. Slide courtesy of the Microbicide Trials Network

50. Rectal microbicide research
• RMP 01 – UC-781
• MTN 006 – tenofovir
• MTN 007 – modified
tenofovir
ENROLLED MTN 017
• 36 U.S. (m/f)
• 18 U.S. (m/f)
• 65 U.S. (m/f)
• 192 Peru, RSA, Thailand,
U.S., PR (gay, msm, tgw)
50

51. MTN-017
A Phase 2 Randomized Sequence Open
Label Expanded Safety and
Acceptability Study of Oral
Emtricitabine/Tenofovir Disoproxil
Fumarate Tablet and Rectally-Applied
Tenofovir Reduced-Glycerin 1% Gel

52. N = 192
Participants
Gay/MSM,
transgender
women
Study sites
• US (4)
• Thailand (2)
• RSA (1)
• Peru (1)
[Sept ’13 – June ‘16 ]

54. 54

55. 017 in brief
• Study regimens include:
– Rectal tenofovir gel used daily
– Rectal tenofovir gel used before and after sex
– Truvada tablets taken daily
• Each participant followed all of the study regimens for
eight weeks, with a weeklong break between regimens
when no product used
– The order in which participants followed study regimens based on random
assignment
• All participants received standard HIV prevention
package

56. 017 study design
Product
Sequence
N Period 1
(8 weeks)
Product
Break
(1 week)
Period 2
(8 weeks)
Product
Break
(1 week)
Period 3
(8 weeks)
1 31 Daily Truvada
Daily rectal gel
Rectal gel before
and after sex
2 31 Rectal gel before
and after sex Daily Truvada Daily rectal gel
3 31
Daily rectal gel
Rectal gel before
and after sex Daily Truvada
4 31
Daily rectal gel Daily Truvada
Rectal gel before
and after sex
5 31
Daily Truvada
Rectal gel before
and after sex Daily rectal gel
6 31 Rectal gel before
and after sex Daily Rectal gel Daily Truvada
Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator

57. 11.9 cm long
1.5 cm barrel diameter
4.1 cm tip circumference
57
Vaginal applicator

58. 12.6 cm long
2.6 cm barrel diameter
0.5 cm tip circumference
Rectal applicator (FYI)

59. 12.6 cm long
2.6 cm barrel diameter
0.5 cm tip circumference
Rectal applicator
NOT USED IN MTN 017

60. – Safety
• Compare the safety profiles of rectal tenofovir
gel used daily and before and after sex, and
Truvada tablets
– Acceptability
• Evaluate and compare the acceptability of
Truvada tablets to rectal tenofovir gel
• Did they like the product? Would they use it in
the future, if available?
017 primary objectives
Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator

61. 017 secondary objectives
– Estimate adherence to the products
– Examine whether sexual activity or condom use
varies by product type
– Determine the level of product sharing with non-
participants
– Determine practices associated with anal sex that
could detract from microbicide effectiveness, i.e.
lubes, douching
Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator

62. 017 study visits, procedures
 Screening visit
 Informed consent
 Physical and rectal exams
 HIV risk reduction counseling
 Enrollment visit
 Randomization of participants
 Follow-up visits
 Monthly
 Visit procedures
 Physical exams
 Rectal exams
 Urine and blood tests
 Rectal biopsies (flexible sigmoidoscopy) at some sites
 Behavioral surveys
Slide courtesy of Dr. Ross D. Cranston, 017 Principal Investigator

63. 017 adherence
PK monitoring, “real time” PK
Layered approach to monitoring
•SMS (text messages)
•Product returns
•CASI (computer assisted self interview)

64. 64

65. 65

67. 67

71. PLANNING
FOR EFFICACY

72. tinyurl.com/017update

73. 73

75. *5 year project. Other orgs include UCLA; Duke; University of Pittsburgh; Emory University;
Columbia University; Mercer University and CONRAD

76. Who is IRMA?
76

77. 4 people, 4 agencies, 2 countries
77
IRMA, b.2005

78. 78AIDS Foundation of Chicago is the IRMA secretariat
1200+ advocates,
scientists, funders,
policymakers from 6
continents

79. Mission: support
development of
safe, effective,
acceptable, and
accessible
rectal microbicides
for all that
need them
79AIDS Foundation of Chicago is the IRMA secretariat

80. 80
RM advocacy
and education
Lubricant
safety/access
Engage w/
clinical
research
Anal health, anal sex
Funding, civil
society
support
Engage w/
science and
community

81. 81
Highly active
moderated
listserv
Website
Blog,
Facebook,
Twitter,
YouTube
Global
teleconferences
Materials,
presentations,
video

82. 82

83. 83

86. Special thanks
Ian McGowan
and
Ross Cranston
MTN

89. Thank
you

90. 90
Don’t be a stranger.
jpickett@aidschicago.org