GMHC Treatment Issues, Vol. 10, No. 2; February 1996
Gabriel Torres, M.D.

At the Retroviruses Conference, Michael Saag, M.D., of the University of Alabama presented the highly encouraging first in vivo efficacy data for this compound (abstract 195). These were the interim results from the international phase 1/2 trial underway in Europe and the United States. The study is a dose-ranging one in HIV-positive adults with less than twelve weeks prior AZT therapy and CD4 counts between 200 and 500.

After four weeks, the average HIV viral load dropped in continuing trial participants by a median 1.9 logs (98.7 percent), and after a further eight weeks, in which participants received either AZT or placebo in addition to 1592U89, the viral RNA level was down by 2.1 logs -- representing a 99 percent reduction from baseline at twelve weeks. CD4 counts had increased by an average of 122 at week twelve.

This first cohort of nineteen patients received 1592U89 monotherapy at an oral dose of 200 mg thrice daily. The group's average CD4 count at entry was 352, and its average viral load was 5.1 logs. All but one of the patients were AZT-naive.

Two participants withdrew from the study, one after developing fever, rash and tingling thought to be due to the drug. The main side effects of 1592U89 were nausea in 28 percent of volunteers, headache in 17 percent and rash in 11 percent. One person had an elevation in liver function tests.

The exceptional results for this nucleoside analogue have prompted the investigators to continue the trial. At present, they are enrolling three additional cohorts for higher doses. Since the drug penetrates into the central nervous system, trial participants are asked to allow spinal taps in order to measure the concentration of the drug in the cerebrospinal fluid.

Pivotal trials in AIDS-related dementia also are being developed for 1592U89, as are novel trials that will combine the drug with AZT and 3TC. The new trials are due to begin once the last of the present cohorts has finished. For more information, call Glaxo at 800/437-0992.

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