Global Campaign for Microbicides

Home

Home » About Microbicides » Testing & Trials » Trial Results » Carraguard Trials

Carraguard Trials

Results of the Phase 3 Carraguard Trial

Last updated: 21st February 2008


On 18th February 2008, the Population Council, an international non-profit research institution, posted results on their Phase 3 trial of Carraguard, a microbicide candidate developed as an odorless, clear gel made from carrageenan, a derivative of seaweed.

The Population Council tested Carraguard’s effectiveness in a study conducted between 2004-2007 that enrolled 6,202 women participants in South Africa. Trial results showed that the product was safe and acceptable to women, but did not reduce their risk of acquiring HIV.

Leading advocates call the microbicide trial “trail-blazing” despite the disappointing results -- Microbicide advocates from three major non-governmental organisations hailed the completion of the first large-scale effectiveness microbicide trial as historic, despite the fact that the study showed the product does not protect women against HIV.

Click here to read the press release that GCM issued, jointly with the African Microbicides Advocacy Group and the Gender AIDS Forum.  

Click here to read the update from the AIDS Vaccine Advocacy Coalition (AVAC).

Click here to read the statement issued by the Treatment Action Campaign (TAC)

Click here to read the statement issues by Researchers and Community advocates under the aegis of the New HIV Vaccines and Microbicide Advocacy Society (alias NHVMAG)

Click here to read the statement issued by the International Partnership for Microbicides (IPM).

What can you do as an Advocate?

The Global Campaign for Microbicides (GCM), African Microbicides Advocacy Group (AMAG) and Gender AIDS Forum (GAF) present a summary of what the Carraguard trial results mean to advocates for women-initiated HIV prevention - Please click here for information for Advocates on the Carraguard trial results and their significance.

The Population Council has materials on their website that help advocates understand the trial and the organisation’s microbicides program.   For more specific information about the findings of the trial on their website, please click here.

In 2007, the Global Campaign for Microbicides (GCM), the AIDS Vaccine Advocacy Coalition (AVAC), and the African Microbicides Advocacy Group (AMAG) also published a briefing paper entitled: Female Initiated Prevention: What Will We Learn from Upcoming Trials? Anticipating the Results of the MIRA Diaphragm and Carraguard Microbicide Trials. Although the timeline that is included in this publication are no longer up to date, the issues are still very relevant and timely. This briefing paper and any new information will be available at: http://www.global-campaign.org/trial-updates.htm

Do you have questions or feedback?

General advocacy questions can be sent to the Global Campaign for Microbicides staff at info@global-campaign.org

In addition, the Population Council welcomes any suggestions on how they can work with advocates better. They are also happy to review any materials you may want to develop for your constituents. Please send your questions and any concerns to:

Melissa May, Director of Public Information, Population Council, New York,
mmay@popcouncil.org, +1-212-339-0525

Barbara Friedland, Phase 3 Behavioral Coordinator, Population Council, New York, bfriedland@popcouncil.org, +1-212-330-0629

Sumen Govender, Clinical Trial Manager, Population Trial, South Africa
govenders2@ukzn.ac.za +82 734 8433


Timeline of the results from the Population Council:

Data collection for the Phase 3 clinical trial of Carraguard was completed in March 2007. Below, you find information from the Population Council (the product developer and trial sponsor for the Carraguard trials) about the time line and their communications plan for the trial results.

March 2007:

The Population Council and the three South African institutions that managed the Phase 3 trial completed data collection on 31 March 2007.

June 2007:

The main database was "locked"(no changes to the data made after this point).

July 2007:

Lab data finalized; data analysis and report writing began.

August 2007:

A seroconversion review board confirmed the number of true seroconversions. This involved reviewing the confirmatory tests that had been done during the trial as well as some additional testing of stored samples in order to ensure that no window period infections were included. This additional testing lengthened the original data analysis timeline; however, the Council believes the results will be more accurate.

December 2007:

Final tables received from contract organization doing data analysis; report writing continued (data unblinded).

February 2008:

After the submission of the regulatory reports, the following groups have been confidentially informed of the key findings prior to the public release of the data:

  • South African government officials (national, provincial, and local health departments and ethics committees)
  • Trial participants and communities
  • Key contacts in allied microbicides research and advocacy organizations
  • Selected top-tier journalists in South Africa who cover HIV-related issues.

18th February 2008:

A general announcement has been sent out on 18th February 2008, prior to the Microbicides 2008 conference. A news release has been posted on the Population Council and advocates' web sites, and members of the media have been informed. Results have been presented at Microbicides 2008 in Delhi, India, end of February 08.
In progress

The Population Council is in the process of submitting the final clinical study report to the South African Medicines Control Council and the US Food and Drug Administration.