February 18, 2008

 

Dear Advocates,

 

This update contains information on recent developments in the field of microbicides research. On Monday, February 18, the Population Council announced that its candidate microbicide, called Carraguard, while safe, did not show efficacy in preventing male-to-female transmission during vaginal sex. The news release announcing this finding is online at http://www.popcouncil.org/mediacenter/newsreleases/Carraguard_Findings.html.

 

It is disappointing that this product, while safe, did not show efficacy. The trial itself was a success in that it provided clear answers on safety and efficacy. AVAC joins with its allies in the field in recognizing the dedication and commitment of study volunteers and staff.

 

The Carraguard trial enrolled more than 6,000 women in South Africa. All of the women in the study received HIV education, gynecological exams, risk-reduction and safer-sex counseling, and testing and treatment for curable sexually transmitted infections. Half of the women in the study received the experimental candidate and condoms and half received a placebo gel and condoms. There were comparable rates of infections in the both groups: 134 in the experimental arm and 151 in the placebo arm.

 

Additional resources on Carraguard and microbicides research can be found on the webpages of the Global Campaign for Microbicides (GCM) and the Alliance for Microbicide Development among others.  Female-Initiated Prevention: What will we learn from upcoming trials?, a publication of AVAC, GCM and the African Microbicides Advocacy Group, provides background on the rationale for and research leading up to this and other efficacy trials for female-initiated prevention strategies. We will be updating this publication to reflect these new results.

 

On Tuesday, February 19, the Global Campaign for Microbicides will also be hosting an Advocates' Telebriefing with staff from the Population Council and the Phase 3 trial sites.

 

GCM says:

"If you are available and would like to join in this briefing, please see the call time and dial-in information below. Please be advised that this is likely to be a very crowded call and an operator will be putting callers with questions in an electronic queue to prevent confusion."
 
CALL IN INSTRUCTIONS
The GCM Advocates' Telebriefing will be on Tuesday 19 February 2008 at:

9:30 AM in Washington DC, US

2:30 PM in the UK
4:30 PM in South Africa

8:00 PM in India

To join the call, dial your country's call-in number listed below (no country code required, please dial the numbers exactly as they are written).
When prompted, please enter the participant passcode, 36597307# (you must dial the #).
Participants in the U.S., please dial 1-800-377-8846
Participants in Australia, please dial 1-800-077-126
Participants in Canada, please dial 1-888-276-7715
Participants in India, please dial 000-800-100-6064
Participants in South Africa, please dial 0-800-998-242
Participants in the UK, please dial 0-800-028-1126
Participants in the Netherlands, please dial 0-800-023-1030
Participants in Spain, please dial 900-947-029
Participants in Switzerland, please dial 0-800-561-209 (from land-lines)

Participants in Switzerland, please dial 0-800-561-264 (from mobile phones)

Participants in Thailand, please dial 001-800-156-203-9940

Participants in Denmark, please dial 80-884-696 (from land-lines)

Participants in Denmark, please dial 80-888-848 (from mobile phones)  

 

In other microbicides-related news: on February 14, the UK-based Microbicides Development Programme (MDP) announced that an efficacy trial of a candidate called PRO 2000/5 had been scaled back from two experimental arms to one. The three-arm trial, which is taking place in Uganda, Tanzania, South Africa and Zambia, was testing the microbicide in two different concentrations (2% and 0.5%) alongside a placebo gel.

 

Last week, the MDP announced that a Data and Safety Monitoring Board recommended discontinuing distribution of the 2% gel. This was because of a futility finding, which means that statistical analysis showed that there was no more than a small chance that the high-dose gel would show protection compared to the placebo gel. The DSMB recommended that the low-dose and placebo arms of the trial should continue in order to evaluate safety and effectiveness of the 0.5% dose. Click here to read the MDP public statement on this development http://www.mrc.ac.uk/consumption/groups/public/documents/content/mrc004378.pdf

 

As always, let us know if you have any questions and look forward to updates from the Microbicides 2008 meeting, which will take place in Delhi, India February 24-27.