HIV Infections Clinical Trial
Official title:
A Multicenter, 24-Week Study of the Safety, Pharmacokinetics, and Activity of the Coadministration of Indinavir and Nelfinavir in HIV-1 Seropositive Patients
The purpose of this study is to see if it is safe and effective to treat HIV-infected
patients with indinavir (IDV) plus nelfinavir (NFV), 2 anti-HIV medications.
It is thought that IDV plus NFV will be a safe drug combination for treating HIV.
It is hypothesized that the administration of indinavir with nelfinavir will be generally
safe and well tolerated.
This is a parallel, time-lagged, 2-stage, multiple-dose, 24-week study in HIV-1 seropositive
patients. In the 3-week, randomized, double-blind phase of Stage A, patients receive either
indinavir plus nelfinavir (Group A1: 9 patients) or indinavir placebo plus nelfinavir
placebo (Group A2: 3 patients) for the first week. In Week 2, patients in Group A1 have the
nelfinavir dose increased. This dose escalation for nelfinavir is contingent upon the
patient having completed 1 week of the study drugs without experiencing Grade 3 or worse
toxicity and/or serious drug-related adverse events. Patients in Group A2 continue to
receive placebo until Week 3, at which time they receive indinavir plus nelfinavir (initial
dose), while patients in Group A1 continue with indinavir plus nelfinavir (escalated dose).
At Week 4 all patients in Stage A (including those originally assigned to receive placebo)
receive open-label indinavir plus nelfinavir (escalated dose) for the remainder of the 24
weeks.
After at least 6 patients in Stage A have completed at least 2 weeks of therapy with
nelfinavir plus indinavir with acceptable tolerability, Stage B begins. In the 2-week,
randomized, double-blind phase of Stage B, patients receive either indinavir plus nelfinavir
(Group B1: 9 patients) or indinavir placebo plus nelfinavir placebo (Group B2, 3 patients).
After 2 weeks, all patients in Stage B (including those originally assigned to receive
placebo) receive open-label indinavir plus nelfinavir for the remainder of the 24 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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