To determine the safety and efficacy of a simple, once-daily antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with atazanavir boosted with ritonavir in treatment naive patients.
To determine the safety and efficacy (viral load suppression and cluster of differentiation 4 \[CD4\] changes) of a simple, once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada combined with the protease inhibitor atazanavir (ATV) boosted with ritonavir (ATV/r). To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir. To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir. To evaluate steady-state plasma pharmacokinetics (PK) of Truvada and atazanavir in study subjects receiving Truvada and boosted atazanavir.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg tablet) administered orally once daily (QD)
Atazanavir 300 mg (given as two 150-mg capsules) administered orally QD
Ritonavir 100 mg capsule administered orally QD
Gilead Sciences, Inc.
Foster City, California, United States
Determine the safety/efficacy (viral load suppression and CD4 changes) of a once-daily (QD) antiretroviral (ARV) regimen consisting of a fixed-dose combination tablet containing Truvada.
Time frame: Baseline to Week 48
To evaluate fasting glucose, insulin, C peptide and lipid panel (total cholesterol, high and low density lipoprotein cholesterol (HDL, LDL), and serum triglycerides) in subjects receiving Truvada and boosted atazanavir.
Time frame: Baseline to Week 48
To evaluate adherence to a QD ARV regimen of Truvada and boosted atazanavir.
Time frame: Baseline to Week 48
To evaluate steady-state plasma PK of Truvada & atazanavir in study subjects receiving Truvada and boosted atazanavir.
Time frame: Baseline to Week 48
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