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Delavirdine + Didanosine vs Didanosine in HIV-1
NCT00002123Phase 3
Key facts
- Status
- Completed
- Countries
- 2
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- delavirdine
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, randomised, double-blind trial of delavirdine in human immunodeficiency virus infection (HIV) (2 arms), sponsored by Pfizer. Primary endpoints: Plasma HIV-1 RNA Levels and CD4+ Cell Count. Status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Delavirdine + ddI
Delavirdine mesylate in combination with Didanosine.
ddI Alone
Didanosine monotherapy (with placebo for Delavirdine).
03
Who it enrols
HIV-1 infected patients with CD4 <= 300/mm3 who have received prior AZT therapy but have limited prior ddI exposure.
04
Endpoints
Primary
Plasma HIV-1 RNA Levels
CD4+ Cell Count
Secondary
Incidence of Adverse Events
Pharmacokinetic Parameters
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