drugset / Trial / NCT00105079
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-04
- Primary completion
- 2007-08
- Completion
- 2008-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lopinavir | Other / unclassified | 400 mg | Oral |
| Subject | Saquinavir | Small molecule | 1000 mg | Oral |
| Comparator | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Background | emtricitabine | Other / unclassified | 200 mg | Oral |