At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Chronic HIV-1 infection
- ✓Treatment-naïve (no prior antiretroviral therapy)
- ✓HIV-1 RNA viral load ≥10,000 copies/mL
- ✕Pregnant or breastfeeding
- ✕Active hepatitis B infection
- ✕Prior antiretroviral therapy
- ✕Investigational drug within 4 weeks prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)
In Brief
A Phase 3 clinical trial evaluating saquinavir [Invirase], Lopinavir/ritonavir, and 2 other interventions for HIV Infections. Completed, enrolled 337 participants across 44 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
1000 milligram (mg) Oral (po) twice daily (bid)
Lopinavir/ritonavir 400/100 mg po bid
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
100 mg po bid