Trial information
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Status: Completed
Protocol number: ML18413
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A 48-week, randomized, open-label, 2-arm study to compare the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected patients (GEMINI study)
Brief 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 HIV-1 infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg po bid + emtricitabine/tenofovir 200/300mg po 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.
Target sample size is 337.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: HIV Infections
Intervention type: Drug
Intervention name: saquinavir [Invirase]
Primary outcome: 1. Number and percentage of patients with HIV-1 RNA viral load <50 copies/mL Time frame: Week 48
Key secondary outcomes: 1. Number and percentage of patients with HIV-1 RNA viral load <50 and <400 copies/mL Time frame: Week 48
2. Change from baseline in viral load and CD4+ lymphocyte count Time frame: Week 48
3. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- chronic HIV-1 infection;
- treatment-naive;
- HIV-1 RNA viral load >=10,000copies/mL;
- women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.
Exclusion criteria:
- females who are pregnant or breastfeeding;
- active hepatitis B infection;
- previous treatment with antiretroviral medication;
- patients who have received an investigational drug within the last 4 weeks.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Hamilton, ON
- Ottawa, ON
- Toronto, ON
- Montreal, QC
France
- Lyon
- Marseille
- Nantes
- Nice
- Paris
- Strasbourg
- Tourcoing
Thailand
United States
- Hobson City , AL
- Tucson , AZ
- Los Angeles, CA
- Washington, DC
- Jacksonville, FL
- Miami, FL
- Orlando, FL
- Vero Beach, FL
- Atlanta, GA
- Macon , GA
- Chicago, IL
- Ypsilanti, MI
- St Louis, MO
- Newark, NJ
- Huntersville, NC
- Philadelphia, PA
- Ponce, PR
- Houston, TX
