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The Body Covers: The 12th International AIDS Conference

Poster Session 22352: Co-Administration of Indinavir 1000mg and Escalating Nelfinavir Dose in a Twice-Daily Regimen: Preliminary Safety, Pharmacokinetic and Antiviral Activity

Coverage provided by Michael Giordano, M.D.

June 30, 1998

Very preliminary results from a combination study in 21 patients (all male) of indinavir (1,000 mg every 12 hours) and nelfinavir (750 mg, increased to 1,000 mg, every 12 hours) suggest that twice-daily therapy with this dual protease inhibitor combination may become a potent anti-HIV treatment option. Unfortunately, 8 of the 21 patients withdrew, five due to rises in viral load, 2 were "non-compliant" and one withdrew due to rash, so it is hard to draw strong conclusions from the trial, other than to say more research is needed into this combination.

Patients enrolled had a median viral load of 50,500 copies and median CD4 cell count of 259 cells. After 48 weeks of treatment, 9 out of the 13 patients still enrolled had undetectable viral loads (<400 copies/mL) with 5 of these 9 having viral levels below 50 copies/mL as measured by a more sensitive test. The median increase in CD4 cell count was an impressive 198. It should be pointed out that seven of the 13 patients had reverse transcriptase inhibitors added to their regimens after at least 18 weeks either to counter or to prevent a rise in viral load.

The study is continuing with increased doses of both medications, 1,200 mg of indinavir and 1,250 mg of nelfinavir, both dosed twice-daily in order to gather additional efficacy information on this combination.

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