Study 028, 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 50 to 250 cells/mm³. The study enrolled 996 HIV-1 seropositive patients [28% female, 11% Black, 1% Asian/Other, median age 33 years, mean baseline CD4 cell count of 152 cells/mm³, mean serum viral RNA of 4.44 log₁₀ copies/mL (27,824 copies/mL)]. Treatment regimens containing zidovudine were modified in a blinded manner with the optional addition of lamivudine (median time: week 40). The median length of follow-up was 56 weeks with a maximum of 97 weeks. The study was terminated after a planned interim analysis, resulting in a median follow-up of 56 weeks and a maximum follow-up of 97 weeks. Results are shown in Table 5 and Figures 3 and 4.

Table 5 Protocol 028

Study 028: Figure 3
Indinavir Protocol 028 Zidovudine Naive Viral RNA - Proportions Below 500 Copies/mL in Serum

Study 028: Figure 4
Indinavir Protocol 028 Zidovudine Naive CD4 Cell Counts - Mean Change from Baseline

Study 035 was a multicenter, randomized trial in 97 HIV-1 seropositive patients who were zidovudine- experienced (median exposure 30 months), protease-inhibitor- and lamivudine-naive, with mean baseline CD4 count 175 cells/mm³ and mean baseline serum viral RNA 4.62 log₁₀ copies/mL (41,230 copies/mL). Comparisons included CRIXIVAN plus zidovudine plus lamivudine vs. CRIXIVAN alone vs. zidovudine plus lamivudine. After at least 24 weeks of randomized, double-blind therapy, patients were switched to open-label CRIXIVAN plus lamivudine plus zidovudine. Mean changes in log₁₀ viral RNA in serum, the proportions of patients with viral RNA below 500 copies/mL in serum, and mean changes in CD4 cell counts, during 24 weeks of randomized, double-blinded therapy are summarized in Figures 5, 6, and 7, respectively. A limited number of patients remained on randomized, double-blind treatment for longer periods; based on this extended treatment experience, it appears that a greater number of subjects randomized to CRIXIVAN plus zidovudine plus lamivudine demonstrated HIV RNA levels below 500 copies/mL during one year of therapy as compared to those in other treatment groups.

Study 035: Figure 5
Indinavir Protocol 035 Zidovudine Experienced Viral RNA - Mean Log₁₀ Change from Baseline in Serum

Study 035: Figure 6
Indinavir Protocol 035 Zidovudine Experienced Viral RNA - Proportions Below 500 Copies/mL in Serum

Study 035: Figure 7
Indinavir Protocol 035 Zidovudine Experienced CD4 Cell Counts - Mean Change from Baseline
Genotypic Resistance in Clinical Studies

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