Details

Autor(en) / Beteiligte

• Berenguer, Juan
• González, Juan
• Ribera, Esteban
• Domingo, Pere
• Santos, Jesús
• Miralles, Pilar
• Angels Ribas, Mª
• Asensi, Víctor
• Gimeno, Juan Luis
• Pérez-Molina, José Antonio
• Terrón, José Alberto
• Santamaría, Juan Miguel
• Pedrol, Enric

Titel

Didanosine, Lamivudine, and Efavirenz versus Zidovudine, Lamivudine, and Efavirenz for the Initial Treatment of HIV Type 1 Infection: Final Analysis (48 Weeks) of a Prospective, Randomized, Noninferiority Clinical Trial, GESIDA 3903

Ist Teil von

• Clinical infectious diseases, 2008-10, Vol.47 (8), p.1083-1092

Ort / Verlag

Chicago, IL: The University of Chicago Press

Erscheinungsjahr

2008

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Background. The combination of didanosine, lamivudine, and efavirenz (ddI/3TC/EFV) for the initial treatment of human immunodeficiency virus type 1 (HIV-1) infection has been insufficiently analyzed in clinical trials. Methods. We conducted an open-label, randomized study to compare the noninferiority of ddI/3TC/EFV with the lamivudine-zidovudine tablet and EFV (COM/EFV), both administered with food to improve tolerability and convenience. Patients were stratified by HIV-1 RNA level of <5.0 log10 or ⩾5.0 log10 copies/mL. The primary end point was the percentage of patients with an HIV-1 RNA level of <50 copies/mL at week 48, determined by intention-to-treat analysis. Results. Three hundred sixty-nine patients were randomized: 186 for ddI/3TC/EFV treatment and 183 for COM/EFV treatment. Both groups were well matched in terms of baseline characteristics; 19.3% of patients received a Centers for Disease Control and Prevention assessment of clinical category C, median HIV RNA level was 5.0 log10 copies/mL, and median CD4+ cell count was 208 cells/µL. At week 48, by intention-to-treat analysis, 70% of patients in the ddI/3TC/EFV group and 63% of patients in the COM/EFV group had an HIV-1 RNA level of <50 copies/mL (treatment difference, 7.1%; 95% confidence interval, −2.39% to 16.59%). Fourteen patients (8%) in the COM/EFV arm and 26 patients (14%) in the ddI/3TC/EFV arm discontinued the study medication because of adverse events (P=.046). One patient (1%) in the ddI/3TC/EFV arm and 11 patients (6%) in the COM/EFV arm discontinued medication because of hematological toxicity (P=.003). Conclusions. At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. A statistically significantly higher proportion of patients in the COM/EFV arm than in the ddI/3TC/EFV arm discontinued therapy because of adverse events, mainly because of hematological toxicity. Clinical trials registration. NCT00256828.