Track A and C Late Breaker Session  WESS3
Type:
Special session Back
Venue: Bayside Auditorium A
Time: 16:30 - 17:30, Wednesday, 25.07.2007
Code: WESS3
Chairpersons: François Dabis, France
Margaret Johnston, United States
Click here to see a webcast of this session on kaisernetwork.org

    Presentations in this session:
16:30
WESS302
Abstract		Effectiveness of cellulose sulfate gel for prevention of HIV: results of the phase III trial in Nigeria
Presented by Willard Cates Jr, United States
Halpern V.1, Wang L.1, Obunge O.2, Ogunsola F.3, Mehta N.1, Onyejepu N.2, Oduyebo O.3, Taylor D.1, Otusanya S.3, Umo-Otong J.2, McNeil L.1, Bragg V.1, Cates, Jr. W.1
1Family Health International, Research Triangle Park, United States, 2University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria, 3College of Medicine, University of Lagos, Lagos, Nigeria

16:45
WESS301
Abstract		Phase III trial of 6% cellulose sulfate (CS) gel for the prevention of HIV transmission
Presented by Lut Van Damme, United States
Van Damme L.1, Govinden R.2, Mirembe F.3, Guedou F.4, Solomon S.5, Becker M.L.6, Pradeep B.7, Alary M.4, Nakabiito C.8, Ramjee G.2, Murphy S.1, Deese J.9, Crucitti T.10, Taylor D.9
1CONRAD, Arlington, VA, United States, 2Medical Research Council, HIV Prevention Research Unit, Durban, South Africa, 3Makarere University, Kampala, Uganda, 4Centre hospitalier affilie universitaire de Quebec, Quebec, Canada, 5YRG Care, Chennai, India, 6University of Manitoba, Department of Medical Microbiology, Winnipeg, Canada, 7St John's Medical College, Institute of Population Health and Clinical Research, Bangalore, India, 8Mulago Hospital, Kampala, Uganda, 9Family Health International, Research Triangle Park, NC, United States, 10Institute of Tropical Medicine, Microbiology, Antwerp, Belgium

17:00
WESS303
Abstract		A single dose of an HIV-specific, vaginally-applied microbicide, PSC-RANTES (PSC) can select for a drug resistant SHIV in a macaque model
Presented by Eric Arts, United States
Moore D.1, Veazey R.2, Arts E.1
1Case Western Reserve University, Medicine, Cleveland, United States, 2Tulane National Primate Research Center, Division of Comparative Pathology, New Orleans, United States

17:15
WESS304
Abstract		The diaphragm and lubricant gel for prevention of HIV acquisition in Southern African women: results of a randomized controlled trial
Presented by Nancy Padian, United States
Padian N.1, van der Straten A.1, Ramjee G.2, Chipato T.3, DeBruyn G.4, Blanchard K.5, Shiboski S.6, Montgomery E.1, Fancher H.1, Cheng H.1, Rosenblum M.7, van der Laan M.7, Jewell N.7, McIntyre J.4, the MIRA Study Team
1University of California, Women's Global Health Imperative, San Francisco, United States, 2Medical Research Council, Durban, South Africa, 3UZ-UCSF Research Programme on Women's Health, Harare, Zimbabwe, 4University of Witwatersrand, Perinatal HIV Research Unit, Johannesburg, South Africa, 5Ibis Reproductive Health, Cambridge, United States, 6University of California, Epidemiology & Biostatistics, San Francisco, United States, 7University of California, Biostatistics, Berkeley, United States


Audio files:
  1. audio file - low quality (mp3 format, 13.5 MB)

Rapporteur reports

Track A: HIV Basic Science report by Eric Arts

This late breaker session shared by track A and C focussed on the effectiveness of vaginally applied microbicides.  Drs. Cates and Van Damme presented the recent phase III trial data on cellulose sulfate for the prevention of HIV transmission.  This trial was stopped when revealed that CS was not providing increased protection from HIV infection as compared to the placebo arms.  However, the possible increased risk for HIV infection with CS were not significant when final data was analyzed in the recruited women.

These talks were followed by an in vitro microbicide study presented by Dr. Arts.  His group has identified specific mutations in the V3 loop and gp41 domains of env that were selected in macaques vaginally treated with PSC-RANTES and then exposed to HIV-1.  These mutations were highly enriched by the SHIVP3 virus inoculum with low diversity.  The mutations conferred resistance to PSC-RANTES but did not affect viral fitness. 



Track C: Biomedical Prevention report by Nick Walsh

Results from microbicide clinical trials were presented as well as considerations of resistance

The CONRAD RCT of vaginal cellulose sulphate to prevent HIV transmission (n = 2574) was ceased earlier in 2007 due to concerns about increased HIV incidence in the intervention arm. Van Damme presented results showing the relative risk of HIV in the intervention arm was 2.17 (PP analysis). ITT analysis was non significant. Retention was high at 88%. Further work is being undertaken to investigate the reasons for increase HIV risk in the intervention arm. The FHI cellulose sulphate study, presented by Ward Cates, was stopped at the same time as the CONRAD trial, as a precautionary measure, although there was no increased incidence of HIV with CS gel in this study.

Nancy Padian presented results of the MIRA RCT of diaphragm and lubricant in addition to condoms compared to control group (condoms) in the context of risk reduction counselling and STI diagnosis and treatment (n= 5045 HIV negative women in southern Africa). No significant difference was found between the intervention and control arms on PP analysis. Adherence was 73% at last sex. Retention was 93%. Secondary analysis in continuing to see the effect of the intervention on STI incidence and the acceptability of the intervention.

Eric Arts examined the development of resistance to a single dose of an HIV-specific, vaginally-applied microbicide, PSC-RANTES (PSC) in macaques indicating that microbicide technology may also have to combat resistance in the future.


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