Chennai & Bangalore: Anti-AIDS gel trial called off

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Anti-AIDS gel trial called off

From Kalyan Ray DH News Service New Delhi:

In what may adversely affect managing AIDS in Bagalkot, an

international trial of an AIDS-preventing vaginal cream has suddenly

been called off following preliminary evidence indicating that the

gel may actually help infect the volunteers rather than protecting

them against HIV.

Bagalkot was one of the seven sites where the trial was going on

since September, 2006. The researchers enrolled 23 healthy women from

the high risk group, primarily sex workers, for the trial so far.

They planned recruiting 400 high risk women over 12 months.

The bad news came a week ago when an international independent data

monitoring committee reviewed the data coming out from other sites on

January 26.

Preliminary results from three African sites suggest that cellulose

sulphate – main ingredient in the vaginal cream – has led to

increased risk of HIV infection in women who used the compound. The

trial, being conducted in South Africa, Benin, Uganda and India, was

immediately called off.

" On Jan 27 we were informed and on 28th we closed the trial. This is

a surprising result, " Dr Raynold Washington from St 's Research

Centre in Bangalore who was heading the team told Deccan Herald.

Prior to the Phase-III efficacy trials, there were 11 trials on

cellulose sulphate involving more than 500 participants in Africa,

India, and the US —none of which identified safety concerns.

Out of the 11 trials, nine were for checking the product's safety and

the rest were for finding out the microbicide's efficacy as a

contraceptive.

India has one more site in the YRG Care in Chennai where Dr Suniti

was conducting the trials to test the efficacy of the cream,

Ushercell, developed by Polydex Pharmaceuticals in Canada.

" We started the trial in February 2006 and recruited 255 volunteers.

Most of them are sex workers. We stopped the trial in October as

there were no sero-conversions, " Dr – the first Indian

scientist to isolate the virus – said.

The trial in Chennai site was stopped because there were no HIV

infections among the recruits though the trial proponents – CONARD, a

reproductive health research organisation and Family Health

Organisations – thought that infection may happen in some of these

women.

" We were following up those 255 recruits when this news came. It is

surprising and disappointing, " she said.

" At this point, it is not clear why use of cellulose sulfate was

associated with an increased risk of HIV infection in the CONRAD

trial, " said Dr Lut Van Damme, head of the CONRAD arm of the trial.

The sudden closure of the trial may make it difficult for the

researchers to try out other vaginal creams in future.

http://www.deccanherald.com/deccanherald/feb32007/national225527200722

..asp