Health Canada approves clinical trial for Vancouver AIDS patients

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Health Canada approves clinical trial for Vancouver AIDS patients

OTTAWA - Health Canada has approved a clinical trial protocol that will allow AIDS patients in Vancouver to use the experimental drugs TMC 114 and TMC 125.

Health Canada received the clinical trial protocol on the morning of Monday, December 19, 2005, and approved it a day later, on Tuesday, December 20, 2005. The Department completed its full review and informed the clinical trial sponsor, Dr. Julio Montaner, on the afternoon of December 20, 2005. The protocol describes the way the drugs will be given, how the patients will be monitored and how their rights will be protected.

Health Canada understands the urgency of this situation. The Department has worked as fast as possible to ensure that the patients get safe access to both experimental drugs. This was done through a compassionate use protocol, working with Dr. Montaner and the drug company.

The compassionate use protocol is the best solution in this situation as it ensures that the trial is monitored for safety and that the rights of the patients are protected. Health Canada often offers the option of submitting a protocol when it is not able to authorize the release of experimental drugs. In fact, this option was first proposed in August 2005.

All HIV patients who may need these drugs in the future can benefit from the knowledge gathered in the controlled environment of this clinical trial, including information on both the benefits and the risks of using these experimental drugs.

The next steps are for Dr. Montaner to speak with the chair of his institutional review board and for the manufacturer, Tibotec, through Janssen Ortho Inc., to provide the drug. The manufacturer has already stated publicly that it is willing to provide the drugs.