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GARDEL: Lopinavir/Ritonavir + Lamivudine vs Standard Therapy in Naïve HIV-1
NCT01237444Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2010
- Primary completion
- May 2012
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 3, randomised, open-label trial of lopinavir + ritonavir and lamivudine in human immunodeficiency virus type 1 infection (HIV-1) (2 arms). Primary endpoint: Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at 96 weeks. Started Dec 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Dual Therapy
Lopinavir/ritonavir + Lamivudine
Triple Therapy
Lopinavir/ritonavir + 2 NRTIs
03
Who it enrols
Adults with documented HIV-1 infection, naïve to antiretroviral therapy, with HIV-1 RNA > 1000 copies/mL. Excludes patients with viral resistance to lopinavir/ritonavir, 3TC, or FTC, active Hepatitis B, or active Hepatitis C requiring treatment.
04
Endpoints
Primary
Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL
Secondary
Proportion of patients with HIV-1 RNA levels of less than 400 copies/mL
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