1. www.global-campaign.orgwww.nhv-mag.org Prevention trials pipeline 2006 2008 2009 2010 2007 2012 MOSY3. Willard Cates, HIV Prevention Research: The Optimist’s View Female Barrier- Diaphragm Male Circumcision - Susceptibility Microbicides – CS-1 CS-2 Carraguard Male Circumcision - Infectiousness Microbicides BG/Pro2000 Pro2000 TDF Oral PrEP - IDU HSV-2 Treatment - Infectiousness HSV-2 Treatment – Susceptibility Oral PrEP MSM Heterosexual Index Partner Treatment Vaccines - Adenovirus-1 Adenovirus-2 Vaccines - Prime/Boost Community VCT and HIV Support Oral PrEP - West Africa

2. www.global-campaign.orgwww.nhv-mag.org Research Principles Research must have a potential benefit. Research examines a question to which the answer is unknown. Research must be able to answer the question or contribute meaningful information. Good research must be unbiased. Research is not the same as health care

3. www.global-campaign.orgwww.nhv-mag.org Decision-making about research Data Monitors

4. www.global-campaign.orgwww.nhv-mag.org Data Monitors can stop trial if evidence that test product is definitely effective;

5. www.global-campaign.orgwww.nhv-mag.org Data Monitors can stop trial if evidence that test product may be causing harm

6. www.global-campaign.orgwww.nhv-mag.org Data Monitors can stop trial if evidence that it is futile -- trial can no longer answer the assigned question

7. www.global-campaign.orgwww.nhv-mag.org Data Monitors can stop part of trial MDP 301 trial of PRO 2000 – at 2% and.5% On Feb. 14 – IDMC recommended closing 2.0% arm “as there is no more than a small chance of the high dose showing protection against HIV infection compared to placebo gel” Remaining.05% and comparator gel arms will continue

8. www.global-campaign.orgwww.nhv-mag.org Data Monitors stopped Cellulose sulfate trial in 2007 CONRAD – Benin, India, S. Africa, Uganda – 1333 enrolled – 35 women seroconverted – 23 in test product arm, 11 in placebo arm FHI – Nigeria – 1644 enrolled – 21 women seroconverted – About the same number in each trial arm

9. www.global-campaign.orgwww.nhv-mag.org Data Monitors Decisions on CS Jan 26, 2007 – CONRAD’s DSMB met No problems previously observed Saw possible evidence of harm Recommended that trial stop Jan 29, 2007 – FHI’s DSMB Met No evidence of harm Stopped trial to err on the side of caution

10. www.global-campaign.orgwww.nhv-mag.org r PrEP 2004 --Political controversy can stop trials

11. www.global-campaign.orgwww.nhv-mag.org Trials can end on schedule -- Carraguard Population Council Enrolled 6202 women in 3 South African sites between 2003 and 2007 Regular DSMB looks, no problems observed Trial completed successfully, product appeared to be safe but no evidence of effectiveness

12. www.global-campaign.orgwww.nhv-mag.org Managing fall out of CS results Negative press erupts in South Africa