Stavudine clinical studies: Difference between revisions
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==Clinical Studies== | |||
===Combination Therapy=== | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7745cad8-720d-4755-87c7-9147c0915b0f | publisher = | date = | accessdate = }}</ref> | The combination use of ZERIT is based on the results of clinical studies in HIV-1-infected patients in double- and triple-combination regimens with other antiretroviral agents. | ||
One of these studies (START 1) was a multicenter, randomized, open-label study comparing ZERIT (40 mg twice daily) plus lamivudine plus indinavir to zidovudine plus lamivudine plus indinavir in 202 treatment-naive patients. Both regimens resulted in a similar magnitude of inhibition of HIV-1 RNA levels and increases in CD4+ cell counts through 48 weeks. | |||
===Monotherapy=== | |||
The efficacy of ZERIT was demonstrated in a randomized, double-blind study (AI455-019, conducted 1992–1994) comparing ZERIT with zidovudine in 822 patients with a spectrum of HIV-1-related symptoms. The outcome in terms of progression of HIV-1 disease and death was similar for both drugs.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) CAPSULE, GELATIN COATED ZERIT (STAVUDINE) POWDER, FOR SOLUTION [E.R. SQUIBB & SONS, L.L.C.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7745cad8-720d-4755-87c7-9147c0915b0f | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 07:31, 3 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Clinical Studies
Combination Therapy
The combination use of ZERIT is based on the results of clinical studies in HIV-1-infected patients in double- and triple-combination regimens with other antiretroviral agents.
One of these studies (START 1) was a multicenter, randomized, open-label study comparing ZERIT (40 mg twice daily) plus lamivudine plus indinavir to zidovudine plus lamivudine plus indinavir in 202 treatment-naive patients. Both regimens resulted in a similar magnitude of inhibition of HIV-1 RNA levels and increases in CD4+ cell counts through 48 weeks.
Monotherapy
The efficacy of ZERIT was demonstrated in a randomized, double-blind study (AI455-019, conducted 1992–1994) comparing ZERIT with zidovudine in 822 patients with a spectrum of HIV-1-related symptoms. The outcome in terms of progression of HIV-1 disease and death was similar for both drugs.[1]
References
Adapted from the FDA Package Insert.