The purpose of this study is to see if 3 anti-HIV drug combinations are safe and effective
in patients who have failed previous anti-HIV treatments using nelfinavir (NFV).
Patients receive 1 of 3 salvage regimens. Treatments A and B include delavirdine, 1 of 2
doses of indinavir, and 2 nucleoside reverse transcriptase inhibitors (NRTIs) to which the
patient has not been exposed. Treatment C includes ritonavir, indinavir, and 2 NRTIs to
which the patient has not been exposed. When virologic failure is first observed, the
patient must return in 2 weeks for confirmation of failure and start the salvage regimen
within 1 month of the first assay in which failure was observed. Patients who have less than
400 copies/ml HIV RNA after 16 weeks of therapy are considered responders and continue on
the study. Those who have more than 400 copies/ml after 16 weeks of therapy are considered
nonresponders and should be discontinued from the study. In addition, patients who respond
and subsequently rebound with a viral load 0.5 log above the nadir and greater than 400
copies/ml on 2 consecutive assays at least 2 weeks apart are considered treatment failures
and should be discontinued from the study. Patients have regular physical exams, as well as
virologic, immunologic, and pharmacokinetic assessments.
Patients may be eligible for this study if they:
- Are HIV-positive.
- Had a viral load of less than 400 copies/ml, followed by an increase in viral load
while taking an anti-HIV drug combination including NFV (treatment failure).
- Can start the study treatment within 1 month of treatment failure.
- Have a viral load of less than 30,000 copies/ml when they enter the study.
- Have not taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease
inhibitors (PIs) other than NFV.