To compare tenofovir DF plus lamivudine plus efavirenz vs. stavudine plus lamivudine plus efavirenz in the treatment of HIV-1-infected patients who have never taken antiretroviral drugs and have a viral load of less than 400 copies/mL at week 48.
To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48. To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure. To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Tenofovir DF 300 mg tablets once daily
efavirenz capsules 600 mg once daily
lamivudine 150 mg tablets twice daily
To compare the two treatment groups with the goal of achieving HIV-1 RNA levels less than 50 copies/mL at week 48.
compare the two treatment groups with the goal of achieving HIV-1 RNA levels
Time frame: Week 48
To compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure.
compare the safety, efficacy and tolerability of the two treatment regimens through 144 weeks of drug exposure
Time frame: 144 Weeks
To evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure.
evaluate the long-term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 336 weeks of drug exposure
Time frame: 336 Weeks
To evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
evaluate the long term efficacy, safety and tolerability of tenofovir DF in combination with lamivudine and efavirenz through approximately 480 weeks of drug exposure.
Time frame: 480 Weeks
To evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure.
evaluate the long term efficacy, safety and tolerability of tenofovir DF through approximately 624 weeks of drug exposure
Time frame: 624 Weeks
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stavudine placebo capsules twice daily