The purpose of this study is to see if it is safe and effective to give combinations of
three or four anti-HIV drugs to HIV-infected patients. The drugs used in this study are
delavirdine (DLV), nelfinavir (NLF), didanosine (ddI), and stavudine (d4T).
This is a multicenter, open-label study. Patients are stratified by HIV-1 RNA levels (20,000
to 200,000 copies/ml and greater than 200,000 copies/ml). Patients are equally randomized to
one of four groups and receive antiretroviral therapy for 24 weeks. Group 1 receives
delavirdine (DLV) plus nelfinavir (NFV) plus stavudine (d4T). Group 2 receives DLV plus NFV
plus didanosine (ddI). Group 3 receives NFV plus d4T plus ddI. Group 4 receives DLV plus NFV
plus d4T plus ddI. Patients are evaluated for drug safety and viral burden. Patients may opt
to continue on the study for 24 additional weeks, at the discretion of the investigator.
You may be eligible for this study if you:
- Are at least 18 years old.
- Are HIV-positive.
- Have a CD4 count of at least 50 cells/mm3.
- Have a viral load of at least 20,000 copies/ml.
You will not be eligible for this study if you:
- Have taken d4T.
- Have taken protease inhibitors, including NFV.
- Have taken nonnucleoside reverse transcriptase inhibitors.
- Have taken ddI for 1 month or more.