Washington

Patients taking generic drugs will be permitted to participate in a worldwide trial that aims to find the best way to treat AIDS using antiretroviral medicines, US government officials say.

On 7 October, the scientific advisory board of Community Programs for Clinical Research on AIDS (CPCRA) voted to allow generic drugs to be used in its largest study. The trial, called Strategies for Management of Anti-Retroviral Therapy (SMART), is expected to include some 6,000 patients and to last a decade.

Officials at the US National Institutes of Health (NIH), which is funding the trial, say that the advice to include generic drugs has been accepted. “We're saying that the use of generic drugs in some countries in the study would not compromise the science,” says Sandra Lehrman, director of the Therapeutics Research Program at the NIH's Division of AIDS.

The United States does not allow its foreign aid to be used for buying generic drugs until they have been approved by the US Food and Drug Administration. Although the SMART trial does not fund the purchase of drugs, doctors in some countries said earlier this year that the NIH had decided that patients using generic drugs would not be able to take part in SMART. Doctors and AIDS activists criticized this decision, alleging that it was driven by the political clout of US drug companies, rather than by good medical practice (see Nature 431, 493; 2004).

The CPCRA says it will now consider enrolling patients who are taking generic drugs in the trial “on a country by country and drug by drug basis”. Countries will be required to submit evidence that the drug they want to use has been approved by their own regulators. The CPCRA is now talking to at least one country that would use generic drugs — Brazil — about its participation in SMART.

But it remains uncertain when, or if, other countries will join the trial, which will test alternative strategies for when patients should be treated with antiretrovirals. Enrolment in SMART is already behind schedule: only 40% of the patients expected to enrol this year have been signed up, and critics say the new policy leaves uncertainties in place that might increase delays.

But Martin Delaney of the non-profit AIDS foundation known as Project Inform, who is a member of the CPCRA advisory board, says the policy is a reasonable compromise. A broader approval for all generic drugs would be unwise, he says: “There are so many possible sources of drugs getting into the international AIDS drug market that it would be impossible to simply issue a blanket approval.”