TreatmentUpdate 71, Volume 8, No 7; October 1996
Sean Hosein

To study the effects of this drug 141W94 researchers recruited 42 adult (7 females, 35 males) HIV-infected subjects. Ninety-two percent were either free from symptoms or had mild symptoms of HIV infection. None were supposed to have used protease inhibitors before entering this study. Researchers divided the subjects into 4 groups and gave them several doses of 141W96; 600 mg/day, 900 mg/day, 1800 mg/day and 2400 mg/day for 4 weeks.

Results -- amount of virus

At the start of the study subjects had relatively high levels of HIV in their blood. As well, half the subjects had at least 254 CD4+ cells. The greater the dose of 141W94 used, the greater the decrease in viral load. Subjects receiving 900 mg/day or more of the protease inhibitor had their viral load fall to 1/10th of its pre-study level. Those subjects receiving 2,400 mg of the study drug had their viral load decrease to 1/100th of its prestudy level.

Results -- changes in CD4+ cell counts

The changes in CD4+ cell counts did not mirror the trends in viral load. Half the subjects in the groups below had the following increases in CD4+ cell count:

* 600 mg/day -- 64 cells

* 900 mg/day -- 85 cells

* 1,800 mg/day -- 35 cells

* 2,400 mg/day -- 110 cells

Toxicity

Common side effects included "diarrhea, loose stools, rash and headache." Three subjects left the study early because of rash (2 subjects) and "worsening [intestinal inflammation]."

REFERENCES:

1. The 141W94 International Study group. Preliminary data on the safety and antiviral efficacy of the novel protease inhibitor 141W94 in HIV-infected patients with 150 to 400 CD4+ cells/mm3. Abstract LB 07A.

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