P1094 / Evaluation of the use 3TC

P1094 was multicenter, Phase IV, randomized, controlled, comparative trial of 3TC or FTC monotherapy vs. continuing non-suppressive HAART for 28 weeks among HIV-infected subjects ≥8 to <25 years of age who had documentation of the M184V HIV resistance mutation and were failing their current HAART regimen and were persistently non-adherent.  The study was designed to compare immunologic deterioration during a 28 week “bridging” treatment strategy of 3TC or FTC monotherapy vs. continuing HAART in HIV-infected children, adolescents, and young adults with virologic failure who are likely to be non-adherent to an optimized HAART regimen.