1. Trends in high-risk sexual behaviour among homosexual men participating in the AIDSVAX ® B/B vaccine trial in Canada: Results to 12 months Robert S. Remis, Robert S. Hogg, Jean Vincelette, Ken Logue, Brian Willoughby, Nancy McLean, Jean Roy, Kevin Linnen, Jim Young, Vladimir Popovic University of Toronto, Toronto, Ontario BC Centre for Excellence in HIV/AIDS, Vancouver, BC Centre hospitalier de l’Université de Montréal, Montreal, Quebec cascAIDS Inc, Toronto, Ontario Viron Health, Vancouver, BC VaxGen Inc., Brisbane, CA, USA Canadian Association of HIV/AIDS Research Tenth Annual Scientific Conference Toronto, Ontario, May 31-June 3, 2001

2. MOHLTC, Laboratories Branch, IMC – 2001 Acknowledgements For help in recruitment:For help in recruitment: Action Séro-Zéro, Cohorte OmégaAction Séro-Zéro, Cohorte Oméga AIDS Committee of TorontoAIDS Committee of Toronto Health Hounds, Glen Brown & Associates ConsultingHealth Hounds, Glen Brown & Associates Consulting AIDS Vancouver, Vanguard ProjectAIDS Vancouver, Vanguard Project Community advisory boardsCommunity advisory boards VaxGen Inc (Dr. John Curd, John Jermano)VaxGen Inc (Dr. John Curd, John Jermano) CANVAC (Network of Centres of Excellence), fundingCANVAC (Network of Centres of Excellence), funding Men participating in the AIDSVAX trial for their important contribution to the eventual control of the HIV pandemicMen participating in the AIDSVAX trial for their important contribution to the eventual control of the HIV pandemic

3. MOHLTC, Laboratories Branch, IMC – 2001 Background Behavioural modification can only reduce HIV transmission; HIV continues to spread, especially in developing worldBehavioural modification can only reduce HIV transmission; HIV continues to spread, especially in developing world HIV vaccine is desperately neededHIV vaccine is desperately needed AIDSVAX is only vaccine in Phase III trialAIDSVAX is only vaccine in Phase III trial Began in summer 1998 in U.S.Began in summer 1998 in U.S. Canadian sites include Montreal, Toronto and Vancouver; recruitment July to October 1999Canadian sites include Montreal, Toronto and Vancouver; recruitment July to October 1999 Sexual behaviour is of concernSexual behaviour is of concern Report on data on sexual behaviour to 12 monthsReport on data on sexual behaviour to 12 months

4. MOHLTC, Laboratories Branch, IMC – 2001 Study objectives To examine trends in risky sexual behaviour among participants in the Canadian sites of the AIDSVAX Phase III trialTo examine trends in risky sexual behaviour among participants in the Canadian sites of the AIDSVAX Phase III trial To compare sexual behaviour among participants from Canada, US and NetherlandsTo compare sexual behaviour among participants from Canada, US and Netherlands

5. MOHLTC, Laboratories Branch, IMC – 2001 HIV vaccine trial Double-blind, placebo-controlled trial of bivalent rgp120 HIV-1 vaccine (AIDSVAX ® B/B)Double-blind, placebo-controlled trial of bivalent rgp120 HIV-1 vaccine (AIDSVAX ® B/B) Subjects are men aged 18–60 years who report anal sex with a male partner in the previous yearSubjects are men aged 18–60 years who report anal sex with a male partner in the previous year HIV-negative at first screeningHIV-negative at first screening Receive 7 doses of vaccine or placebo (2:1) over 2½ years (0,1,6,12,18,24 and 30 months).Receive 7 doses of vaccine or placebo (2:1) over 2½ years (0,1,6,12,18,24 and 30 months).

6. MOHLTC, Laboratories Branch, IMC – 2001 Data source and analysis Risk reduction counseling provided at each visitRisk reduction counseling provided at each visit Questionnaire on sexual behaviours in the previous 6 monthsQuestionnaire on sexual behaviours in the previous 6 months Compare proportions at baseline and over time in 3 countriesCompare proportions at baseline and over time in 3 countries Data extracted at VaxGen IncData extracted at VaxGen Inc Significance testing by chi-squareSignificance testing by chi-square

7. MOHLTC, Laboratories Branch, IMC – 2001 Demographic characteristics at baseline Canadan=291USn=5,007Netherlandsn=120 Age (years) MeanMedianRange37.637 18 – 59 36.436 18 – 62 37.136 18 – 58 Race WhiteHispanicBlackAsianOther93%2%1%1%3%82%7%7%1%2%96%0%3%1%0% Education <=High school College Graduate degree 29%40%31%40%40%20%41%42%18%

8. MOHLTC, Laboratories Branch, IMC – 2001 History of drug use and sexually transmitted diseases at baseline Canada n=291 US n=5,007 Netherlands n=120 p-value Any injection of drugs Smoked crack Snorted cocaine/heroine AmphetamineSTDSyphilisNGU0.0%2.4%14.4%12.7%1.7%0.3%3.4%0.2%2.0%12.3%8.9%2.2%0.1%3.2%0.0%5.8%10.8%5.8%2.5%0.0%5.8%NS0.01NS0.04NSNSNS

9. MOHLTC, Laboratories Branch, IMC – 2001 Sexual behaviours (previous 6 months) at baseline Canadan=291USn=5,007Netherlandsn=120p-value Male partners Mean number 10+ partners Oral sex Any unprotected anal sex Unprotected receptive anal Unprotected insertive anal 16.639%52%53%32%43%12.632%43%58%37%47%20.458%32%48%28%37%0.0010.020.050.03 Male HIV+/? partners Had an HIV+/? partner Oral sex Any unprotected anal sex Unprotected receptive anal Unprotected insertive anal 90%41%40%21%33%82%27%39%21%32%98%23%32%16%22%0.0010.001NSNS0.05

10. MOHLTC, Laboratories Branch, IMC – 2001 Trends in unprotected anal sex reported (previous 6 months), Canada

11. MOHLTC, Laboratories Branch, IMC – 2001 Trends in receptive anal sex with HIV+/? partner, Canada, US and Netherlands

12. MOHLTC, Laboratories Branch, IMC – 2001 Trends in unprotected receptive anal sex with HIV+/? partner, Canada, US and Netherlands

13. MOHLTC, Laboratories Branch, IMC – 2001 Limitations Subjects not representative of gay populationSubjects not representative of gay population Data on sexual behaviour self-reportedData on sexual behaviour self-reported Decreases in sexual behaviour could be due to selective drop-out and infection; however, unlikely given the low attrition rateDecreases in sexual behaviour could be due to selective drop-out and infection; however, unlikely given the low attrition rate

14. MOHLTC, Laboratories Branch, IMC – 2001 Conclusions Subjects are engaging in high risk sexual behaviourSubjects are engaging in high risk sexual behaviour This will provide sufficient power to measure HIV vaccine efficacyThis will provide sufficient power to measure HIV vaccine efficacy Participation does not appear to lead to increasing risky sexual behaviourParticipation does not appear to lead to increasing risky sexual behaviour Study subjects and trends in sexual behaviour generally comparable in 3 countriesStudy subjects and trends in sexual behaviour generally comparable in 3 countries