Conditions: HIV-1
Keywords: HIV-1. Treatment Naive HIV Infections treatment naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 195
Healthy volunteers: no

Brief summary:
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Detailed description:

Arms:
arm 1: UK 453,061 Dose One plus Truvada arm 2: UK 453,061 Dose Two plus Truvada arm 3: Efavirenz + Truvada

Interventions: intervention 1: UK-453, 061 intervention 2: UK-453, 061 intervention 3: EFV +TVA
Intervention descriptions: intervention 1: UK-453,061 500 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 2: UK-453,061 750 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 mg tablets PO QD. intervention 3: Efavirenz 600 mg tablets PO QD + Tenofovir DF 300 mg/Emtricitabine 200 tablets mg PO QD.

Protocol document: