GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir
or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human
immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment.
Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice
daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir
400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study
treatment is 3-12 months, and the target sample size is 100-500 individuals.