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The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Full description
In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:
Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.
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Inclusion and exclusion criteria
Inclusion Criteria
Prior Medication:
Allowed:
Less than 1 month prior treatment with zidovudine.
Exclusion Criteria
Prior Medication:
Excluded:
Prior indinavir.
Prior lamivudine.
Prior protease inhibitors.
Prior non-nucleoside reverse transcriptase inhibitors.
1 month or more prior zidovudine.
CD4 coun tis above 50.
HIV-1 RNA levels greater than 20,000.
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Data sourced from clinicaltrials.gov
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