Massive microbicide trial on women in SA & Botswana
Four thousand South African women will this year test a seaweed-based gel that is science’s latest hope in preventing the transmission of HIV/AIDS.
The microbicide gel – branded as Carraguard – is made from a substance in seaweed called carrageenan that may be able to block the HI Virus from entering the body through the walls of the vagina and cervix.
If Carraguard is successful, it will enable women to protect themselves against HIV without their partners’ consent. This is very important in relationships where women feel they lack the power to insist on condom use.
Two thousand HIV negative women from Gugulethu and Nyanga in Cape Town, 2 000 from Ga-Rankuwa in Pretoria and a further 2 000 women from Francistown, Botswana, will be recruited for the phase III trial of the gel.
A third of the women will be given the gel, a third will use a placebo and a third won’t get anything. However, all 6 0000 women will be educated about HIV transmission, given free condoms and treated for other sexually transmitted infections if necessary.
Carraguard has been developed by the non-profit US-based Population. It has already been through initial safety trials, the most recent of which (phase II) were conducted in South Africa and Thailand.
“Although the final results are not yet available, early indications show no significant causes of irritation in HIV negative women,” said Dr Nicol Coetzee of the University of Cape Town. Coetzee and Dr Anwar Hoosen from the Medical University of SA (Medunsa) are the co-principal researchers in the South African trial, together with Dr Janneke van de Wijgert from the Population Council.
Carageenan contains “large sugar-like molecules, that are not absorbed in the body”, says Dr Coetzee. “It is believed that carageenan coats both the virus and the cells of the vagina and cervix, thus preventing infection by the HI virus and other sexually transmitted diseases,” said Dr Coetzee.
In animal studies, Carraguard also blocked sexually transmitted viruses such as the herpes simplex virus type 2 and human papillomavirus, (which can lead to cervical cancer) as well as the bacterial gonorrhea.
Dr Coetzee added that “carrageenan has been used for years as an emulsifier and stabiliser in products such as ice cream, baby formula and eye drops” and is already on the US Food and Drug Administration’s ‘generally recognised as safe’ list.
“Because it comes from seaweed, it is widely available and reasonably priced.”
In the recent Phase II safety trial, 565 South African women – half using the gel and half a placebo — were monitored for six to 12 months. They were asked to insert the gel vaginally every second day and an hour before having sex.
“We are still collating all the fieldwork, but our preliminary findings show the gel posed no dangers for the women,” said Coetzee.
Once the Phase II research data has been processed, the researchers will apply for permission for the trial from the Medicines Control Council and the FDA. The trial will then run for four years.
Tom Kenyon, who heads the Population Council in Botwana, also confirmed that his organisation was in the process of developing Phase III protocols and would soon be applying for permission for the trial in that country.
Meanwhile, the Gates Foundation announced last Saturday (2 Feb) that it would provide $20 million to cover the costs of the trial, which is being spearheaded by the non-profit Population Council.
“We are thrilled that the Gates Foundation has recognised this potential,” said Linda Martin, President of the Population Council. “Many women cannot ensure the monogamy of their sexual partners, nor can they always negotiate condom use. And the development of a vaccine has not gone as quickly as we all had hoped.”
Author
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Kerry Cullinan is the Managing Editor at Health-e News Service. Follow her on Twitter @kerrycullinan11
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Massive microbicide trial on women in SA & Botswana
by Kerry Cullinan, Health-e News
February 7, 2002
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