This indication is based on Week 24 analyses from two randomized, double- blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
The following points should be considered when initiating therapy with
-- Treatment history and, when available, resistance testing, should guide
the use of INTELENCE.
-- The use of other active antiretroviral agents with INTELENCE is
associated with an increased likelihood of treatment response.
-- In patients who have experienced virologic failure on an
NNRTI-containing regimen, do not use INTELENCE in combination with
-- The risks and benefits of INTELENCE have not been established in
pediatric patients or in treatment-nave adult patients.
DUET-1 and -2 Study Design
The DUET-1 and -2 studies, identical in design but conducted in different regions, assessed the 24- and 48-week efficacy and safety of INTELENCE in combination with a BR in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. The primary endpoint was the proportion of patients who achieved a confirmed undetectable viral load (less than 50 copies/mL)
Patients with HIV-1 who were eligible for the DUET studies had a viral load of greater than 5,000 copies/mL while on a stable antiretroviral therapy regimen for at least eight weeks and had evidence of at least one NNRTI- resistance-associated mutation, either at screening or from prior resistance tests, as well as evidence of three or more primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening.
Participants in the DUET studies were randomized to receive INTELENCE
200 mg twice daily (599 patients) or pl
|SOURCE Tibotec Therapeutics|
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