Once a Day (QD) - Twice a Day (BID) Clinical Trial: Didanosine, Lamivudine and Efavirenz Versus Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of HIV

Summary

The purpose of this study is to compare the antiviral activity of two treatment groups for HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the starting treatment of human immunodeficiency virus infection at Week 48.

Timeline

Start

2004-06

Primary completion

—

Completion

2006-11

Outcome

Met primary endpoint

paper At week 48, ddI/3TC/EFV administered once per day with food did not have results inferior to those of COM/EFV treatment. PMID 18781872 ↗

Publications

• Berenguer J, Gonzalez J, Ribera E, Domingo P, Santos J, Miralles P, Angels Ribas M, Asensi V, Gimeno JL, Perez-Molina JA, Terron JA, Santamaria JM, Pedrol E; GESIDA 3903 Team. 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. Clin Infect Dis. 2008 Oct 15;47(8):1083-92. doi: 10.1086/592114.

Drugs

Indications