A randomized pilot study of triple nucleotide reverse transcriptase inhibitors therapy with tenofovir, zidovudine (AZT) plus emtricitabine in antiretroviral naive HIV-1 infected patients - The TEAZE study

A randomized pilot-study to evaluate the virologic efficacy of Tenofovir-DF (TDF) 300 mg/Emtricitabine (FTC) 200 mg once daily plus Zidovudine (AZT) 250 mg twice daily (armA) or 300 mg BID (armB) in naive HIV-1 infected patients. Twenty patients with a median CD4 cell count of 288 cells/µl (standard deviation (SD): ± 109) and a median viral load of 66.400 HIV RNA copies/ml (SD: ± 70.700) were included. Three patients in armA and one in armB had a single HIV-RNA-PCR measurement of > 50 copies/ml (p = 0.58). The combined median CD4 cells increased by 188 cells/µl at week 48. TDF 300 mg/FTC 200 mg once daily in combination with AZT 250 mg or 300 mg twice daily was well tolerated and no virologic failure occurred.   Key words: Class sparing, nucleoside reverse transcriptase inhibitor (NRTI), K65R, drug interaction