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ATLANTIC: 3 Drug Combinations in Naive HIV
NCT00002407Phase 4
Key facts
- Status
- Completed
- Countries
- 1
- Sponsor
- Weill Cornell Medicine
- Modality
- Small Molecules
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 4, randomised, open-label trial in human immunodeficiency virus type 1 infection (HIV-1) comparing 3TC Arm, Indinavir Arm and Nevirapine Arm (3 arms). Primary endpoints: Proportion of patients with HIV-1 RNA < 500 copies/mL at 48 weeks and Proportion of patients with HIV-1 RNA < 50 copies/mL at 48 weeks. Status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
3TC Arm
Stavudine + Didanosine + Lamivudine
Indinavir Arm
Stavudine + Didanosine + Indinavir
Nevirapine Arm
Stavudine + Didanosine + Nevirapine
03
Who it enrols
Antiretroviral-naive patients with HIV-1 infection, CD4 > 200 cells/mm3, and HIV RNA > 500 copies/mL.
04
Endpoints
Primary
Proportion of patients with HIV-1 RNA < 500 copies/mL
Proportion of patients with HIV-1 RNA < 50 copies/mL
Secondary
Change in CD4+ Cell Count
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