AEGiS-GMHC: Treatment Briefs: Matching up Ritonavir with Saquinavir

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Treatment Briefs: Matching up Ritonavir with Saquinavir

GMHC Treatment Issues, Vol. 10, No. 4 - April 1996

A trial to study the much heralded protease inhibitor combination of ritonavir and saquinavir is now screening applicants. Because of its liver-inhibiting properties, full dose ritonavir will raise blood levels of saquinavir about ten-fold and make this drug much more effective. Conversely, increasing saquinavir's effectiveness may allow a reduction in the dosage of ritonavir, thus reducing side effects. The combination also might be less prone to trigger the emergence of treatment-resistant HIV than either drug alone.

At first, the volunteers will receive saquinavir at 400 mg twice daily plus ritonavir at 400 or 600 mg twice daily. Once safety is established, the doses will increase to saquinavir at 800 mg twice daily plus 400 mg ritonavir twice daily or saquinavir at 600 mg twice daily plus 600 mg ritonavir twice daily. Everyone will receive both drugs in this open-label, 48-week trial.

This 120-person trial (in Annandale (Virginia), Boston, Los Angeles, New York, Ottawa, Pittsburgh and San Francisco) is open to volunteers with CD4 counts between 100 and 500, any viral load and no previous protease inhibitor experience. One or two concomitant nucleoside analogs will be allowed if an individual's viral load rebounds to within one log (ten percent) of the pre-trial value. Otherwise, no other anti-HIV drugs will be allowed during the trial.

"This might be a powerful combination. If people are on nucleoside analogs and failing, then this is a great study for them," commented Marty Markowitz, M.D., the trial's New York City investigator.

Further information on this trial may be obtained from the Abbott Laboratories consumer hotline, 800/441-4987.

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