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

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