An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Hoffmann-La Roche26 sites in 3 countries146 target enrollmentOctober 1999

ConditionsHIV Infections

DrugsRitonavir Efavirenz Saquinavir

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Enrollment: 146
Locations: 26
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare 2 anti-HIV drug combinations.

Detailed Description

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

Registry

clinicaltrials.gov

Start Date

October 1999

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All