(ATN) 3TC Trials Recruiting: NIH, Boston, Vancouver

(ATN) 3TC Trials Recruiting: NIH, Boston, Vancouver

AIDS TREATMENT NEWS #140, December 6, 1991
John S. James

3TC, a new anti-HIV drug being developed by Glaxo Inc., is now in a phase I/II trial at three North American sites: the U. S. National Cancer Institute near Washington, D. C., Boston City Hospital, and St. Paul's Hospital in Vancouver, British Columbia; a different trial is also underway in Paris, London, and Amsterdam. The drug is a nucleoside analog (in the same class as AZT, ddC, or ddI); laboratory studies suggest that it may be less toxic than these drugs. The North American trial is open to volunteers with advanced ARC or AIDS.

Six different dose levels will be tested, from 0.25 mg/kg twice daily to 6.0 mg/kg twice daily, with ten to 15 volunteers in the trial at each level. The lowest dose is already fully enrolled. The trial will last for six months, and there are provisions for continuing the drug beyond that time if it appears to be safe and effective. All doses are given orally, with volunteers remaining for 12 hours after the first dose (this is the only hospitalization required), and returning to the clinic for later tests -- monthly after the first two months, more frequently before that. Volunteers must have T-helper counts of 300 or less, and be off antiretrovirals (AZT, ddC, ddI) for at least 21 days before the first T-cell test. There are also other entry criteria, including the usual laboratory tests for hematological, liver, and kidney function, and exclusions for certain conditions (such as ongoing treatment for most infections, or Kaposi's sarcoma which is likely to require treatment in the next three months), and exclusion for certain concurrent drugs treatments.

For more detailed information about this trial, including names and phone numbers of contact persons at the three North American sites, call the AIDS Clinical Trials Information Service, 800/TRIALS-A.

Comment

There is more interest now than a few months ago in new nucleoside analog drugs, since the non-nucleoside reverse- transcriptase inhibitors which had been expected to replace them (such as the Merck "L-drugs" and Boehringer Ingelheim's BI-RG- 587) have encountered major problems with rapid development of viral resistance.

We have not seen any data on 3TC, but there seems to be significant enthusiasm for it. Glaxo is one of the world's largest pharmaceutical companies (although not well known to the public in the U. S.); it has the resources and ability to develop the drug rapidly.

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