Study Shows Norvir, AZT, 3TC Regimen Renders Patients Aviremic
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Study Shows Norvir, AZT, 3TC Regimen Renders Patients Aviremic

VANCOUVER, July 11, 1996 -- A triple therapy regimen of the protease inhibitor Norvir(R) and the nucleoside analogues AZT and 3TC has rendered nine HIV-infected patients aviremic, as determined by culture and plasma RNA measurements, according to research presented here today at the 11th International Conference on AIDS.

In the study, which is being conducted by investigators at the Aaron Diamond AIDS Research Center in New York, 12 patients newly infected with the HIV virus received a three-drug regimen consisting of 600 mg Norvir twice daily, 200 mg AZT three times daily, and 150 mg 3TC twice daily, beginning within 90 days of infection. Baseline plasma RNA for all 12 patients was 91,389 RNA copies/ml plasma at the initiation of therapy.

Patients have been followed for various lengths of time, ranging from 90 days to 300 days, depending on when they began the, regimen. One patient withdrew from the study due to intolerance to all three drugs; while two non-compliant patients elected to discontinue therapy. At the furthest point of data collection for each of the nine patients remaining on the regimen, all patients are aviremic by PBMC co-culture, plasma culture and RNA determinations. Therapy is planned to continue for a minimum of one year, at which time lymphatic tissue will be obtained and assessed for active HIV replication.

"Early results indicate that the regimen of Norvir, AZT and 3TC has rendered nine patients newly infected with HIV aviremic,'' said Martin Markowitz, M.D., of the Aaron Diamond Center, who is the lead investigator on the study. ``While this is very encouraging news, it's important to note that these results cannot yet be called a cure. We don't know if the virus will rebound if patients were to cease the regimen. Studies are underway to find an answer to this question.''

Norvir, manufactured byAbbott Laboratories, was cleared by the U.S, Food and Drug Administration March 1, 1996, for the treatment of HIV infection.

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