Microbicide Trials On HIV Transmission Prevention Halted

Malawi will continue with phase 3 Trials on the efficacy of a microbicide gel that is being tested for HIV prevention in women despite trials of a similar kind being halted in other participating countries.

A statement made in January by International Partnerships for Microbicides (IPM) informing the public that CONRAD, a reproductive health research organization had halted the phase 3 efficacy trials of its Cellulose Sulfate (CS) based microbicides has resulted in the public asking why the trials on being carried out by John Hopkins Foundation in Malawi are still continuing.


According to Dr Newton Kumwenda, Director of the John Hopkins Foundation, the research in Malawi will not be affected by IPM's statement to stop the CS trials because the products are different.

"The trials in Malawi are not affected in any way be the stopping of the Cellulose Sulfate trials since the products are different" he said.

Kumwenda confirmed that trials are on track, will continue and are progressing well.

Malawi is currently involved in phase 3 human trials of the Pro 2000 and Buffer Gel microbicide being carried out in two centers based in Blantyre and Lilongwe. Approximately 500 women are involved in each of the two centers.

Trials in Malawi on the Pro 2000 and Buffer Gel started in 2005 and data has regularly been monitored by a safety monitoring board. Reviews since trials began have already taken place 4 times with another review due to take place shortly.

According to Kumwenda, the past reviews have revealed no problems so far thus the continuation of trials. "We hope that if trials are stopped at all, it will be due to successful results rather than other problems," he said.

Asked how participants are selected for the trial, Kumwenda said all trials are being conducted with utmost care following both local and international guidelines for the welfare of the participants as well as the scientific integrity of trial.

Participants should be 18 years or older, sexually active, healthy and be willing to be tested for HIV.

Before participating in the trials, women are counseled and informed on the importance of continuing to use other forms of protection against HIV.

"They are counseled that the products are only being tried if they can protect against infection, but we do not know for sure if they work therefore they need to protect themselves against HIV all the time by using condoms which we know for sure are effective," Kumwenda said.

Counseling is continuing and available for participants whenever a request is made. At every opportunity a participant is available, counseling on risk reduction is provided.

Kumwenda confirmed again that CS is a completely different product from Pro 2000 and Buffer Gel being tried in Malawi and that it was unlikely that the different products will have the exact same effects. "We hope that the Buffer Gel and Pro 2000 will have different and positive results."

The trials on Pro 2000 and Buffer Gel taking place in Malawi are at present being carried out in Philadelphia USA, South Africa, Zambia and Zimbabwe.

Effort to develop a microbicide gel for use by women to prevent them from contracting HIV suffered a significant setback when the phase 3 human trials were halted end of January this year.

Phase 3 of the trial involved the participation of women in order to determine the efficacy of the Cellulose Sulfate based gel but preliminary results indicated that Cellulose Sulfate could lead to an increased risk of HIV infection in women who use the product.

Trials on the CS have been carried out in Benin, India, South Africa, Uganda and Nigeria. A target total of 4,734 women were scheduled to participate in the trials.

Although problems were observed in the other countries, no such problems were observed in the Nigerian trials and data is still being examined further to shed some light on the apparent observations so far and their implications.

It has been confirmed that increasingly women and girls bear the brunt of the HIV/AIDS pandemic.

In the year 2006 statistics reveals that over 59% of the people living with the virus in sub-Saharan Africa were women.

In Malawi, over 52% of the people living with HIV are women.

Traditions, culture and social differences are some of the most significant factors that have made women more vulnerable to becoming infected with HIV.

The development of a microbicide is expected to have given women, especially those in a stable relationship or married some control over protecting themselves from becoming infected with HIV or other sexually transmitted Infections (STIs). Not requiring the participation of the male partner, microbicides had been seen as a positive move towards empowering women to protect themselves from HIV and STI infections.

A significant number of women in Asia and Africa have been involve in large scale efficacy trials

"With these microbicide candidates in large scale efficacy trials and a new generation of microbicides well into safety studies, microbicides could be available in five to seven years," is a statement by IPM in November, 2006.

The safety concerns that caused the discontinuation of the CS trials is seen as a set back and will have a significant effect on the future development and availability of a microbicide that will empower women to protect themselves against HIV the world over.