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Trial Results

It is important to understand the results of flat trials (or trials that do not prove that a drug is effective) in context of the development of new drugs in general. In the field of new drug development, as many as 8 or 9 out of every ten product leads fail in human testing. If researchers had given up on finding treatment and prevention options for other diseases after a handful of failures, we would have far fewer options in healthcare today. For example the first polio vaccine (Salk) took almost 50 years to develop.

When a microbicide that is both safe and effective is found, millions will benefit. Each piece of information, be it analysis from a product that did not prove effective or revelation in the laboratory is a step in the right direction.

In our effort to keep you updated with the latest microbicide news, we will be posting and updating the most recent information about microbicide trial results and trial closures. 

CAPRISA 004: Tenofovir gel
CAPRISA 004 was a phase IIb, two-arm, double-blind, randomised, placebo-controlled trial designed to assess the safety and effectiveness of the vaginal microbicide candidate 1% tenofovir gel for the prevention of HIV infection in women in South Africa.

The trial commenced enrolment in May 2007 and completed follow-up in December 2009. The results of the trial will be released at the International AIDS Conference in Vienna, Austria, on Tuesday 20 July 2010. Read more...

MDP 301: PRO 2000
Results from the Microbicides Development Programmes' (MDP) 301 multi-site clinical trial of the 0.5% PRO 2000 candidate microbicide were released in December 2009. The clinical trial involving 9,385 women in East and Southern Africa has demonstrated that a vaginal microbicide gel PRO 2000 (0.5%) while safe does not prevent HIV infection in women.  Read more...

HPTN 035: PRO 2000 & BUFFER GEL
On 9th February 2009, the US National Institutes of Health announced promising results of a multi-site clinical trial of two candidate microbicides. Known as HPTN 035, the trial evaluated the safety and effectiveness of BufferGel® and PRO 2000 (0.5 percent dose) for preventing male-to-female sexual transmission of HIV.  Read more...

CARRAGUARD
Data collection for the Phase 3 clinical trial of Carraguard was completed in early 2007, and the results from this trial have been announced on 18th February 2008.  Read more...

Read a briefing paper for advocates Female Initiated Prevention: Anticipating the Results of the MIRA Diaphragm and Carraguard Microbicide Trials,

Learn more at the Population Council's microbicides website.

VIVAGEL
On October 16, 2007, StarPharma - an Australian bio-tech and sponsor of the candidate microbicide VivaGel - announced an agreement with SSL International (the makers of Durex condoms) to pursue a condom-coating microbicide product.  This announcement elicited a number of questions and concerns from advocates and researchers.  The International Rectal Microbicides Working Group (IRMWG) and GCM spearheaded an advocacy response and drafted a letter to StarPharma outlining some of the questions and concerns being prompted by their announcement. Within 3 days, StarPharma responded.

Read the letter to StarPharma
Read StarPharma's response

In June 2006, similar questions arose when StarPharma announced the beginning of trials to test the effectiveness of VivaGel for the prevention of genital herpes.  Read the press release and StarPharma's response to advocate's questions.

SAVVY
On September 19, 2007 Family Health International (FHI) provided an update on the data obtained through their trials of Savvy (C31G) in Ghana and Nigeria. 

Statement from Family Health International
Q&A: Answering Hard Questions on the Savvy Trial Results

MIRA DIAPHRAGM
On July 13, 2007 the MIRA (Methods for Improving Reproductive Health in Africa) diaphragm study released their findings. In the context of this overall HIV prevention package, it was found that there was no added protective benefit from the diaphragm and lubricant and it is NOT recommended that a diaphragm be used or promoted for HIV prevention. Read more...

CELLULOSE SULFATE
At the end of January 2007, the Data Safety and Monitoring Boards (DSMB) of CONRAD met and based on a review of preliminary data, recommended that the Phase III trial of the candidate microbicide Cellulose Sulfate (CS) in Benin, India, Uganda and South Africa be discontinued. Read more...

In early 2008, GCM posed a series of questions to the former principal investigators of the CS trials to follow-up on what progress has been made.  Read their responses.

MALE CIRCUMCISION
In December 2006, an interim analysis conducted by the Data Safety Monitoring Board overseeing the Kenyan and Ugandan male circumcision trials made the decision to discontinue the trials due to overwhelming evidence that circumcision significantly reduces HIV risk among men. Read more…

NONOXYNOL-9
Nonoxynol-9 (or N-9) is the active ingredient in most over-the-counter birth control products available in the United States, Canada and Europe. Until recently, scientists believed that vaginal use of nonoxynol-9 offered some – albeit limited – protection against bacterial STIs such as gonorrhea and chlamydia. There was also early hope that N-9 could provide protection against HIV. However, after a long and complicated history of testing, scientists have concluded that products containing N-9 do not offer protection against HIV and, in fact, may increase risk of HIV transmission when used frequently. From this experience, some people have assumed that because N-9 did not work as a microbicide that the entire concept of anti-infective microbicides has been proven not to work. This conclusion, however, is wrong and misleading. Read more…