Study 903 Methods
Study 903 is an on-going Phase III clinical trial of tenofovir DF or stavudine (d4T) in combination with 3TC and EFV (Figure 1)
In this interim analysis, plasma HIV was analyzed from all patients with virologic failure during the first 48 weeks (ITT analysis)
- genotypic analyses performed by Virco (amino acids 1-400 of RT)
- phenotypic analyses performed by Virco and ViroLogic (all licensed antiretroviral drugs)
Virologic failure was defined as patients with > 400 copies/mL of HIV RNA at week 48 or at early discontinuation for any reason
Week 48 or last available sample was analyzed (last on-study)
- earlier samples analyzed for patients who developed mutations in their HIV to determine the time course of mutation development