DUET Trials Design
The DUET trials (TMC125-C206 and TMC125-C216) are 2 randomized, double-blind, placebo-controlled, Phase 3 trials* comparing INTELENCE® (etravirine) 200 mg twice daily with a background regimen (BR).
The background regimen for both arms consisted of darunavir/ritonavir + ≥2 other investigator-selected ARVs (N[t]RTIs ± enfuvirtide [ENF])
DUET study inclusion criteria
ARV treatment-experienced HIV-1 infected adult patients on a stable ARV regimen for ≥8 weeks with:
- HIV-1 RNA >5000 copies/mL
- ≥1 NNRTI resistance-associated mutation (RAM)† at screening or from prior genotypic analysis
- ≥3 primary PI mutations‡ at screening
- Randomization was stratified by intended use of ENF in the BR, prior use of darunavir/ritonavir, and screening viral load (HIV-1 RNA)
Primary objective
- Evaluate virologic response defined as undetectable viral load (HIV-1 RNA <50 copies/mL)2
Please see Important Safety Information.
*DUET-1 (TMC125-C206) and DUET-2 (TMC125-C216).
†Based on the list of primary NNRTI mutations from the DUET trials: A98G, L100I, K101E/P/Q, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179I/F/G, Y181C/I/V, Y188C/H/L, G190A/E/S, P225H, F227C, M230I/L, P236L, K238N/T, Y318F.2
‡Based on the International AIDS Society (IAS)-USA list of primary PI mutations (November 2005): D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, L90M.
§Based on the Janssen Therapeutics list of NNRTI RAMs (June 2008): A98G, V90I, L100I, K101E/H/P/Q, K103H/N/S/T, V106A/M/I, V108I, E138A/G/K/Q, V179D/E/F/G/I/T, Y181C/I/V, Y188C/H/L, V189I, G190A/C/E/Q/S, H221Y, P255H, F227C/L, M230I/L, P236L, K238N/T, Y318F.
¶Based on the International AIDS Society (IAS)-USA list of primary PI mutations (August/September 2007): D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54L/M, L76V, V82A/F/L/S/T, I84V, N88S, L90M.