Trial of Rapid HIV Test in Africa

A clinical trial has been initiated to evaluate the sensitivity and specificity of a rapid antibody test for HIV.

The test, called Aware, can be used with blood, oral fluid, or urine. The trial is being conducted in the Republic of Uganda at the HIV/AIDS Reference and Quality Assurance Laboratory, Uganda Virus Research Institute, in Entebbe. The trial will evaluate about 350 subjects and is the first to be performed with Aware in sub-Saharan Africa.

The trial is being performed under the direction of Dr. Benon Biryahwaho, laboratory coordinator at the Uganda Virus Research Institute. The Aware test was developed by Calypte Biomedical Corp. (Pleasanton, CA, USA). The company expects data collection to be completed in the second quarter of 2005. Contingent upon positive results from the trial, Calypte expects to file for regulatory approval in Uganda by mid-2005.

"Getting these trials underway is an important milestone for Calypte,” stated Dr. J. Richard George, president and CEO of Calypte. "We have made great efforts to adhere to our timelines to bring these tests to market, and we are pleased to kick off the African regulatory effort with Dr. Biryahwaho, who has long been a central figure in the Ugandan HIV control effort.”

"We have continued to assess new technologies for the detection of HIV/AIDS in order that the Ugandan public should benefit from the most advanced scientific developments in the delivery of AIDS services and care,” noted Dr. Biryahwaho. "HIV/AIDS testing empowers people to be informed and hence make appropriate choices. In Uganda, the problem is access and equity. Calypte has made it easier by formulating simple rapid technologies.”

Calypte intends to initiate additional regulatory trials in key African and Far East markets over the course of 2005. Additionally, the company expects to begin clinical trials in the coming months utilizing its first commercial application of the technology acquired from Ani Biotech (Vantaa, Finland) in October 2004. These additional studies using the Ani platform will be initially conducted by Dr. Biryahwaho in the coming months and will continue in other key markets throughout 2005.

Dr. George added, "We believe the Ani format will provide additional options to the African market. The technology transfer for the rapid HIV-1/2 tests using the Ani platform has occurred much quicker than initially expected. We have been able to successfully transfer the technology to our Rockville manufacturing facility, allowing us to qualify both platforms and initiate the Ani trials in Uganda in the coming months. The Ani platform is well suited for both the professional markets as well as over-the-counter applications and represents the future platform for all of Calypte's diagnostic endeavors.”

Uganda has a population of over 26 million. According to the United Nations AIDS 2004 report on the global AIDS epidemic, as of the end of 2003 there were about 530,000 adults and children in Uganda living with HIV/AIDS, down from an estimated 620,000 two years earlier. It is estimated that over one million HIV diagnostic tests were conducted in Uganda in 2004, most of which were rapid tests.




Related Links:
Calypte Biomedical