Module 5 State of NPT Research wwwicadcisdcom Status of research What happened with these trials Nonoxynol 9 Savvy Circumcision Cellulose Sulphate Merck vaccine CAPRISA 004 tenofovir ID: 587114
Download Presentation The PPT/PDF document "New Prevention Technologies Workshop" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
Slide1
New Prevention Technologies WorkshopModule 5: State of NPT Research
www.icad-cisd.comSlide2
Status of researchSlide3
What happened with these trials?Nonoxynol 9Savvy
Circumcision
Cellulose
Sulphate
Merck vaccine
CAPRISA 004 (
tenofovir gel)iPrEx
AIDSVAX
AIDSVAX/ALVAC
MIRA (Diaphragm)
PRO 2000
BufferGel
Carraguard
FEM-
PrEP
Treatment as preventionSlide4
Outcomes of past studies
Signs of efficacy
No efficacy
Safe
Circumcision
AIDSVAX/ALVAC
CAPRISA 004 (tenofovir gel)
iPrEx
Treatment as prevention
CarraguardBufferGelPRO 2000AIDSVAXMIRA (diaphragm)FEM-PrEPTend towards harmNonoxynol-9SavvyCellulose sulphateMerck vaccineSlide5
NPT late-stage trials: When will we know?
2012+
PrEP
Injection drug users
PrEP
Serodiscordant couples
PrEP
/Microbicides
Women
Vaccine*Men who have sex with menSlide6
PrEP: When will we know?Where
Who
What
When
Thailand (CDC)
Injection drug users
tenofovir
2012
Uganda, Kenya
(Partners PrEP)Serodiscordant couples (men and women)tenofovir, Truvada2012South Africa, Uganda, Zambia, Zimbabwe (VOICE)Women
tenofovir
(pill & gel),
Truvada
2013Slide7
ProductTrial sponsor
Phase
Location(s)
Results expected
Tenofovir gel
MTN
(VOICE)
2b
South Africa, Uganda, Zambia, Zimbabwe
2013Microbicides: When will we know?Slide8
Vaccines: When will we know?Phase 22009-10 discovery of new “broadly neutralizing antibodies” – possibly good target for further research
Where
Who
What
When
US (HVTN/NIH)
Men who have sex with men
Prime/boost (DNA/Ad5)
2012Slide9
Social and behavioural issuesSlide10
Social and Behavioural IssuesPerceptions of “risk” Risk compensation (e.g., condom substitution?)Gender implications Stigma Community preparednessSlide11
Social and Behavioural QuestionsHow would the introduction of NPTs impact the risk, negotiation, and autonomy of receptive sexual partners who generally have low control over condom use by their insertive partners? How best can CBOs be supported for NPT preparedness and communications at the community level?What are the
social mechanisms by which NPTs could serve as a catalyst for broader structural changes in gender norms?Slide12
Access to nptsSlide13
Who will have access? Who decides?Most « at-risk » groups? Who is that in the national context?
What factors will influence this?
The general public?
How will decisions be made?Slide14
How will it be available?Is it available now?
Will it require a prescription?
Who will pay?
Will testing be a condition?Slide15
What practical questions are raised?What if I use this differently than how it was tested in trials?
Will receptive partners (male or female) who use a partially effective NPT find it harder to get their partner to use a condom?
How will our healthcare system deal with the increase in testing?Slide16
What ethical questions are raised?
What are the implications of limiting access to prevention options only to certain groups?
How do we deal with the stigma of associating some prevention tools with high-risk populations?
How do we deal with access inequality within our country? Between countries?Slide17
The elephant in the room…. Is it ethical to supply ARVs to HIV-negative people for prevention even though most HIV-positive people who need ARVs to prolong their lives do not get them? Slide18
What research questions are raised?
Do trial results in one population translate to other populations?
What if someone uses this when they are HIV+?
Can I take this when I’m pregnant?
Will it hurt my baby?
What about breastfeeding?Slide19
ExerciseWhat are some of the key considerations to keep in mind when thinking about access to NPTs for:Women in African countriesWomen in Canada
Gay men in developing countries
Gay men in CanadaCanadians of African or Caribbean descent
Persons who inject drugs
Aboriginal peopleSlide20
Why aren’t large pharmaceutical companies investing?Perceived low profitability
Liability concerns
Lack of in-house expertise
Uncertain regulatory environment
Public Funding is Essential
Global Annual Microbicides R&D
Investment 2009 in USD$ millionsSource: HIV Vaccines and Microbicides Resource Tracking Working GroupSlide21
“Sure, you know about [all types of existing and new prevention options]... We need you to unravel the secrets of the science, to make all of that elusive and mysterious information accessible to the untutored rest of us…
Somehow, along with the science, we need the activism. They are inseparable.”
Stephen Lewis
Co-Director, AIDS-Free World, and
Former United Nations Secretary-General’s
Special Envoy for HIV/AIDS in Africa (2001–2006)July 19, 2009International AIDS Society ConferenceCape Town, South Africa
© Nick Wiebe 2006