Tenofovir DF (Disoproxil Fumarate) in Combination With Emtricitabine in HIV-1 Patients

Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for participation in the study. HIV-1 infection Either antiretroviral therapy-naive requiring antiretroviral treatment with HIV-1 RNA greater than 400 copies/mL or antiretroviral therapy-experienced on a stable antiretroviral regimen for at least 3 mos. with HIV-1 RNA less than or equal to 50 copies/mL at screening. No active opportunistic infection within 45 days prior to baseline. Able to understand and sign the informed consent form and comply with the study. Stable renal impairment within the four defined groups for at least 3 mos., based on creatinine clearance (Cockcroft-Gault method). Exclusion Criteria: Patients who meet any of the following are not to be enrolled in this study. Women who are pregnant or breastfeeding Fanconi syndrome or multiple myeloma, tertiary hyperparathyroidism, malignancy (with the exception of basocellular carcinoma) or myeloproliferative disorder. Women of childbearing potential who are unwilling to use an effective contraceptive method during the study Contraindications to tenofovir DF, emtricitabine or efavirenz Undergoing treatment for tuberculosis Using atazanavir Prior history of mutation M184V, K65R or T69 insertion Z-score on pre-baseline DEXA scan less than -2.5 The following laboratory values within 30 days prior to study entry: *absolute neutrophil count (ANC) less than 750/mm3, *hemoglobin less than 9.0 g/dL, *platelet count less than 50,000/mm3, *AST (SGOT) or ALT (SGPT) less than 5 x ULN and *CD4 cell count less than 100/mm3. Use of nephrotoxic agents or competitors with renal excretions, including aminoglycoside antibiotics, intravenous amphotericin B, cidofovir, cisplatin, foscarnet, intravenous pentamidine, probenecid or other agents with significant nephrotoxic potential Clinically significant cardiac, pulmonary or gastrointestinal disorder Alcohol or drug abuse that could hinder compliance with the study