The purpose of this study is to provide long-term clinical safety and efficacy data for tenofovir disoproxil fumarate and emtricitabine in HIV-infected patients experiencing various degrees of renal impairment.
Name: Truvada (tenofovir DF + emtricitabine)
Type: Drug
Name: Emtriva (emtricitabine)
Type: Drug
Name: Viread (tenofovir DF)
Type: DrugAllocation: Non-Randomized
Single Group Assignment
There are 2 SNPs
- 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. --- M184V --- --- K65R ---
- 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. --- M184V ---