Leoni Bücken

2021-06-27T18:31:55.818Z

crixivan in combination with antiretroviral agents is indicated for the treatment of hiv infection this indication is based on two clinical trials of approximately 1 year duration that demonstrated 1 a reduction in the risk of aids defining illnesses or death 2 a prolonged suppression of hiv rna in all clinical studies with the exception of actg 32 the amplicor hiv monitor assay was used to determine the level of circulating hiv rna in serum this is an experimental use of the assay hiv rna results should not be directly compared to results from other trials using different hiv rna assays or using other sample sources study actg 32 was a multicenter randomized double blind clinical endpoint trial to compare the effect of crixivan in combination with zidovudine and lamivudine with that of zidovudine plus lamivudine on the progression to an aids defining illness adi or death patients were protease inhibitor and lamivudine naive and zidovudine experienced with cd4 cell counts of 2 cells mm 3 3 1 table 4 figures 1 2 table 4 actg 32 number of patients with aids defining illness or death endpoint idv zdv l zdv l idv indinavir zdv zidovudine l lamivudine hiv progression or death 35 6 1 63 1 9 death the number of deaths is inadequate to assess the impact of indinavir on survival 1 1 7 19 3 3 study actg 32 figure 1 indinavir protocol actg 32 zidovudine experienced plasma viral rna proportions below 4 copies ml study actg 32 figure 2 actg 32 zidovudine experienced cd4 cell counts mean change from baseline study 28 a double blind multicenter randomized clinical endpoint trial conducted in brazil compared the effects of crixivan plus zidovudine with those of crixivan alone or zidovudine alone on the progression to an adi or death and on surrogate marker responses all patients were antiretroviral naive with cd4 cell counts of 5 to 25 cells mm 3 3 1 table 5 figures 3 4 table 5 protocol 28 number of patients with aids defining illness or death endpoint idv zdv idv zdv hiv progression or death 21 6 3 27 8 1 62 18 7 death the number of deaths is inadequate to assess the impact of indinavir on survival 8 2 4 5 1 5 11 3 3 study 28 figure 3 indinavir protocol 28 zidovudine naive viral rna proportions below 5 copies ml in serum study 28 figure 4 indinavir protocol 28 zidovudine naive cd4 cell counts mean change from baseline study 35 was a multicenter randomized trial in 97 hiv 1 seropositive patients who were zidovudine experienced median exposure 3 months protease inhibitor and lamivudine naive with mean baseline cd4 count 175 cells mm 3 1 1 figures 5 6 7 study 35 figure 5 indinavir protocol 35 zidovudine experienced viral rna mean log1 change from baseline in serum study 35 figure 6 indinavir protocol 35 zidovudine experienced viral rna proportions below 5 copies ml in serum study 35 figure 7 indinavir protocol 35 zidovudine experienced cd4 cell counts mean change from baseline study 6 1 15 93 1 12 94 was a dose ranging study in which patients were initially treated with crixivan at a dose of 2 4 g day followed by 2 4 g day study 19 6 23 94 4 1 95 was a randomized comparison of crixivan 6 mg every 6 hours crixivan plus zidovudine and zidovudine alone table 6 table 6 genotypic resistance at 24 weeks treatment group resistance n includes patients with non amplifiable virus at 24 weeks who had amplifiable virus at week resistance idv 2 4 g day 31 37 84 2 4 g day 9 21 43 1 17 6 idv zdv 4 22 18 1 22 5 zdv 1 18 6 11 17 65

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z

Leoni Bücken

2021-06-27T18:31:55.818Z