The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).
Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
730
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AIDS Healthcare Foundation
Los Angeles, California, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Med Alternatives
Fort Lauderdale, Florida, United States
Hillsborough County Health Dept
Tampa, Florida, United States
The CORE Ctr
Chicago, Illinois, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Univ of Louisville
Louisville, Kentucky, United States
CRI of New England
Brookline, Massachusetts, United States
CRI - Springfield
Springfield, Massachusetts, United States
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