Boehringer-Ingelheim Announces Clinical Trial to Test Once-daily Extended-release
Nevirapine (Viramune)
Seeking
to move into the arena of simplification of anti-HIV therapy, Boehringer Ingelheim
last week announced the start of recruitment into the VERXVE study.
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Viramune
Tablet |
VERXVE
is a randomized, double-blind, double-dummy, parallel-group, active controlled
trial to evaluate the antiviral efficacy of 400 mg once-daily nevirapine
(Viramune).
The
study will compare standard twice-daily 200 mg nevirapine in combination with
Truvada (the fixed-dose combination
pill containing tenofovir + emtricitabine) in treatment-naive HIV patients, with
once-daily dosing using a new extended-release formulation of nevirapine in a
single 400 mg tablet, also in combination with Truvada.
The
primary endpoint is virological response at 48 weeks, defined as HIV viral load
less than 50 copies/mL prior to week 48, without subsequent rebound or change
of antiretroviral therapy by week 48. Secondary endpoints will include other efficacy
endpoints, safety, and pharmacokinetic parameters.
Patients will be randomly
assigned to receive either 400 mg nevirapine extended-release formulation once-daily
or 200 mg nevirapine twice-daily, after a 14-day lead-in period during which all
participants will receive 200 mg once-daily nevirapine.
The
current nevirapine CD4 cell count initiation criteria will be applied to both
arms of the study. Guidelines recommend that women
with > 250 cells/mm3 and men with > 400 cells/mm3 should not receive nevirapine
due to an elevated risk of hypersensitivity reactions.
The
study will enroll approximately 1000 HIV positive treatment-naive patients at
planned sites in 18 countries. Recruitment is scheduled throughout 2008. Participants
will be treated for up to 48 weeks, with an extension through 144 weeks. Results
are expected to be available in 2010.
2/19/08
Source
Boehringer Ingelheim. Boehringer Ingelheim initiates new HIV/AIDS Trial
for extended release formulation of Viramune. Press Release. February 12,
2008.
