The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
To estimate the differences in parameters of antiviral activity and safety between a control
regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose
indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease
inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive
patients.
It is hypothesized that after 16 weeks of randomized treatment with either the control or
experimental regimen that:
1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the
experimental and control regimen will be similar and will continue to be so after 48
weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of
serious, drug-related adverse experiences and the incidence of events of specific
interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and
CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA
and CD4 counts and will continue to be so after 48 weeks.