South Africa: Still No Verdict On Anti-HIV Gel
By, Tamar Kahn, Business Day (Johannesburg), July 26, 2007
Researchers are still unsure whether the Ushershell microbicide used in the aborted international study involving South African women was harmful, but it clearly did not protect women against HIV, the 4th International AIDS Conference heard yesterday.
"We don't think it's effective, and there may be an indication of increased risk (of contracting HIV)," said Lut van Damme, international clinical research manager with the US-based health research group Conrad.
The group stopped clinical trials of Ushershell in January, after interim analysis of trial data from about 1400 women in SA, Benin, Uganda and India showed the gel might do more harm than good. Half the women used the gel, which contained a cotton-based compound called cellulose sulphate, and the rest used a dummy version.
Ten earlier studies and two contraceptive trials had shown the gel to be safe.
Van Damme told delegates that final data analysis showed 25 women who used the Ushercell gel got HIV, compared to 16 women who had used the dummy. "It was a shock to all of us," she said.
Van Damme said there were several possible reasons why the gel might have failed to protect women from HIV, such as causing inflammation, or disturbing the natural vaginal flora. She said a new Ushershell safety study was planned, which would involve 60 women in the US.
"It would be unethical not to try and understand what's going on," she said.
SA is at the forefront of international research into anti-HIV microbicides as it has good research infrastructure and an HIV-positive population of more than 5,5-million.
Scientists hope microbicides will offer women a discreet way to reduce their risk of contracting HIV from an infected partner, particularly where men are reluctant to use condoms. The South African arm of the Ushershell research was headed by the Medical Research Council's Prof Gita Ramjee, and funded by the US Agency for International Development and the Bill and Melinda Gates Foundation.
A week after the trial was stopped, Health Minister Manto Tshabalala-Msimang ordered the National Health Research Ethics Council to investigate all anti-HIV vaginal gel trials in SA. It has yet to report its findings.
A second Ushercell study in Nigeria was also stopped as a precaution when the Conrad trial was halted.
A nalysis of the data from the Nigerian sites found no apparent increase in HIV risk among the women who used the cellulose sulphate microbicide, Willard Cates from Family Health International told the conference.
Source: http://allafrica.com/stories/200707260086.html
Researchers are still unsure whether the Ushershell microbicide used in the aborted international study involving South African women was harmful, but it clearly did not protect women against HIV, the 4th International AIDS Conference heard yesterday.
"We don't think it's effective, and there may be an indication of increased risk (of contracting HIV)," said Lut van Damme, international clinical research manager with the US-based health research group Conrad.
The group stopped clinical trials of Ushershell in January, after interim analysis of trial data from about 1400 women in SA, Benin, Uganda and India showed the gel might do more harm than good. Half the women used the gel, which contained a cotton-based compound called cellulose sulphate, and the rest used a dummy version.
Ten earlier studies and two contraceptive trials had shown the gel to be safe.
Van Damme told delegates that final data analysis showed 25 women who used the Ushercell gel got HIV, compared to 16 women who had used the dummy. "It was a shock to all of us," she said.
Van Damme said there were several possible reasons why the gel might have failed to protect women from HIV, such as causing inflammation, or disturbing the natural vaginal flora. She said a new Ushershell safety study was planned, which would involve 60 women in the US.
"It would be unethical not to try and understand what's going on," she said.
SA is at the forefront of international research into anti-HIV microbicides as it has good research infrastructure and an HIV-positive population of more than 5,5-million.
Scientists hope microbicides will offer women a discreet way to reduce their risk of contracting HIV from an infected partner, particularly where men are reluctant to use condoms. The South African arm of the Ushershell research was headed by the Medical Research Council's Prof Gita Ramjee, and funded by the US Agency for International Development and the Bill and Melinda Gates Foundation.
A week after the trial was stopped, Health Minister Manto Tshabalala-Msimang ordered the National Health Research Ethics Council to investigate all anti-HIV vaginal gel trials in SA. It has yet to report its findings.
A second Ushercell study in Nigeria was also stopped as a precaution when the Conrad trial was halted.
A nalysis of the data from the Nigerian sites found no apparent increase in HIV risk among the women who used the cellulose sulphate microbicide, Willard Cates from Family Health International told the conference.
Source: http://allafrica.com/stories/200707260086.html
posted by AIDS-Care-Watch at 1:11 pm
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