NIAID Begins Study of New Drug for HIV Infection

SENTBY:NIAID/OFFe of COMM.

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In the first phase of the study, up to 40 patients will be randomly assigned to receive either
a three-drug combination of U-90,152, AZT and ddlI or a two-drug combination of just AZT and
dI. Investigators will gradually increase the dose of U090,152 for each new group of five patients
to determine the maximum dose that is well-tolerated.
In the second phase of the study, up to 40 additional participants with 100 to 300 CD4+ T
cells/mm3 will receive either U-90,152 alone or in combination with AZT. The initial dose of U90,152 in this phase of the study will be the maximum tolerated dose established in the first phase.
Patients with fewer than 100 CD4+ T cells/rn will also be enrolled during this second phase to
evaluate the effects of the combination regimen in patients with more advanced disease.
The trial is designed to assess the relative safety of the therapies, and will provide
information on their side effects. The study also will examine how the drugs are metabolized by
the body, and provide preliminary Information on the relative effectiveness of the therapies in
slowing the progression of IV disease.
Dr. Lane says his group's preliminary findings with BHAP compounds are consistent with
a report in the Feb. 18 Nature in which investigators at Massachusetts General Hospital, supported
by the National Institutes of Health (NIH), showed that a combination of three dmgs--AZT, ddl
and nevirapine--could successfully stop the growth of HIV or its spread to other cells.
Nevirapine also is a non-nucleoside reverse transcriptase inhibitor, but differs significantly
in chemical structure from BHAP compounds. A clinical trial of the combination of AZT, ddl and
nevirapine will open later this spring in the AIDS Clinical Trials Group (ACTG), one of NIAID's
three nationwide clinical trials networks.
An ongoing trial, ACTG 199, is evaluating another BHAP drug, U-87,201, in 20 patients.

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