News

CAPRISA 004: CONRAD EXECUTIVE DIRECTOR, HENRY GABELNICK, IN THE NEWS

July 21, 2010

CONRAD Executive Director, Henry Gabelnick, Ph.D., discussed the next steps for tenofovir gel following promising results from the CAPRISA 004 clinical trial showing the gel to be 39% effective in reducing a woman’s risk of becoming infected with HIV during sex.

Kaiser Family Foundation Interview with Henry Gabelnick (CONRAD) and Ward Cates (FHI)

CONRAD Executive Director, Henry Gabelnick, Ph.D., and Family Health International President of Research, Ward Cates, M.D., M.P.H., discuss the CAPRISA 004 trial results that showed tenofovir gel to reduce the risk of sexual transmission of HIV by 39%.

To view the video, click here.

“Microbicides – Where Next?” – aidsmap.com

Now that the CAPRISA 004 trial has shown tenofovir gel to be 39% effective in reducing a woman’s risk of acquiring HIV during sex, will the gel be made available to women at risk of contracting the virus? Experts indicate that despite the promising results, additional confirmatory studies are needed; it will still be at least 3-4 years before the product is available to the public.

CONRAD provided supplies of tenofovir gel for the CAPRISA 004 trial. When asked about next steps, Dr. Gabelnick indicated that the two regulatory bodies, the U.S. Food and Drug Administration and the South African Medicines Control Council, would be approached to determine what additional trials are necessary to secure regulatory approval.

To read the full article, click here.

“Fast-track Anti-HIV Gel, says Minister” - Mail & Guardian Online

South African Health Minister Aaron Motsoaledi announced at the International AIDS Conference in Vienna that the South African government would consider fast-tracking tenofovir gel through the regulatory process in order to provide the product to the public in a more timely manner.

In the article, Dr. Gabelnick states that work is already underway to move tenofovir gel to the clinic. South Africa’s Technology Innovation Agency will form a public-private partnership with a South African-based pharmaceutical company to manufacture the gel and will work to receive regulatory approval from the South African Medicines Control Council. A larger trial will still be needed to confirm the CAPRISA 004 results and answer additional questions including whether different dosing regimens, formulations, or delivery systems would be most effective in protecting women from HIV.

To read the full article, click here.

“Africa: Microbicides – From Results to Reality” - allafrica.com

Results from the CAPRISA 004 clinical trial of tenofovir gel are promising, but it will still be several years before the gel is available to the public. Data from the CAPRISA trial still need to be analyzed and the regulatory bodies need to be approached to determine additional confirmatory trials needed.

Many questions remain to be answered, including the formulation of the final product. In the article, Dr. Gabelnick states, “We are not sure in what form the product will eventually come. The applicator might be reusable [applicators were used once in the study], it might come in toothpaste type tubes…we don’t know.”

To read the full article, click here.



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