Abstract
Background: The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected patients. Methods: The primary objective at week 48 was to investigate durability of efficacy, as measured by the percentage of patients maintaining their week 24 response or improving. Efficacy analyses used the intent-to-treat population. Results: A total of 73.7% of patients randomized to the enfuvirtide group remained on treatment through week 48 versus 21.3% originally randomized to the control group. At week 48, a higher proportion of week 24 responders maintained their response or were new responders in the enfuvirtide group than in the control group in each responder category: HIV-1 RNA level ≥1.0 log10 change from baseline,
Original language | English |
---|---|
Pages (from-to) | 404-412 |
Number of pages | 9 |
Journal | Journal of Acquired Immune Deficiency Syndromes |
Volume | 40 |
Issue number | 4 |
DOIs | |
Publication status | Published - Dec 2005 |
Keywords
- Efficacy
- Enfuvirtide
- Fusion inhibitor
- HIV
- Subgroups
- TORO
ASJC Scopus subject areas
- Virology
- Immunology