Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:09:35 PM