Ingelheim, Germany (ots/PRNewswire) -
- Trial to compare newest protease inhibitors in
treatment-experienced patients with resistance to more than one PI
Boehringer Ingelheim GmbH announced today that enrollment of the
POTENT study will begin in August 2007. POTENT will compare the
efficacy and safety of Aptivus(R) (tipranavir) versus darunavir,
both with ritonavir as part of combination antiretroviral therapy.
POTENT will include 800 treatment- experienced patients in 15
countries. The primary endpoint is time to virologic failure, with a
secondary endpoint of virologic response at 48 weeks of treatment.
In the ongoing RESIST trials, APTIVUS demonstrated superior
virologic and immunologic responses versus a comparator group of
protease inhibitors in highly treatment-experienced patients through
96 weeks of therapy (p<0.001).(1) The POTENT study will be the first
head-to-head study comparing APTIVUS to another protease inhibitor
developed specifically for treatment-experienced patients with HIV
resistant to multiple agents in the protease inhibitor class.
"Treatment-experienced patients need active treatment options to
help achieve and maintain undetectable viral load. Tipranavir and
darunavir are important antiretroviral agents for these patients and
there is much to learn regarding their respective roles in treatment.
POTENT is an important study because it will help provide physicians
and patients with this information to guide future treatment
choices," said Laurent Cotte, M.D., Hepatology/AIDS Unit, Hotel-Dieu
Hospital, Lyon, France.
The POTENT (PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in
Treatment Experienced Patients) study will be a Phase IV, open-label,
multinational, randomised study of patients previously treated with
three classes of antiretrovirals, with a minimum of three months
duration in each class, and documented resistance to more than one
protease inhibitor. Virologic response will be defined as viral load
of less than 50 copies/mL. Patients will be randomised to receive 500
mg of APTIVUS boosted with 200 mg of ritonavir twice daily or 600mg
of darunavir boosted with 100 mg of ritonavir twice daily. Both
agents will be administered with an optimized background regimen,
which may include certain investigational agents. Patients will be
observed for a period of 48 weeks.
"Boehringer Ingelheim is committed to the ongoing study of
APTIVUS, and anticipates that POTENT will reinforce the therapeutic
benefits of APTIVUS for HIV-positive treatment-experienced patients.
We expect results from the study will be available in 2010," said Dr.
Andreas Barner, Vice-Chairman, Board of Managing Directors and Head
of Corporate Board Division Pharma Research, Development and
Medicine, Boehringer Ingelheim.
The POTENT study will enroll 800 patients in more than 150 sites
across 15 countries. HIV-1 infected male and female patients aged 18
years and older will have been on their current failing protease
inhibitor-containing regimen for at least 8 weeks, will have a CD4+
cell count of greater than or equal to 50 cells/mm3 and a viral load
count of greater than or equal to 1000 copies/mL. Patients who have
had a prior AIDS-defining event will be eligible as long as the event
has resolved for at least twelve weeks before screening, excepting
patients with a history of progressive multifocal
leukoencephalopathy, visceral Kaposi's sarcoma, and/or any
APTIVUS is a new non-peptidic protease inhibitor which works by
inhibiting the viral protease, an enzyme needed to complete the HIV
replication process. It is approved for combination antiretroviral
treatment of HIV-1 infected adults that are highly pre-treated with
virus resistant to multiple protease inhibitors.
Based on available clinical and in vitro data, APTIVUS is active
against most strains of HIV-1 that are resistant to commercially
available protease inhibitors.
Currently, phase II and III studies in paediatric and other
populations are fully enrolled and ongoing.
The most commonly reported side effects of at least moderate
intensity in patients enrolled in the RESIST studies taking APTIVUS
are gastrointestinal, including diarrhoea, nausea, vomiting and
abdominal pain. Fever, fatigue, headache, bronchitis, depression and
rash also occurred. Gastrointestinal symptom disorders and elevated
transaminase, cholesterol and triglycerides were more frequent in the
APTIVUS arm than in the comparator-ritonavir group but necessitated
discontinuation of treatment in a minority of cases.
APTIVUS boosted with low-dose ritonavir has been associated with
reports of hepatic adverse events, which have included some
fatalities. These have generally occurred in patients with advanced
HIV disease taking multiple concomitant medications. Extra vigilance
is warranted in patients with chronic hepatitis B or hepatitis C
co-infection, as these patients have an increased risk of liver
toxicity. The most common moderate to severe laboratory abnormalities
were elevated liver enzymes and elevated lipid levels. Most
laboratory abnormalities were asymptomatic and most patients were
successfully treated without discontinuation.
APTIVUS-containing HAART regimens have been associated with
reports of both fatal and non-fatal intracranial hemorrhage (ICH) in
some highly treatment-experienced patients. Caution should be used
when prescribing APTIVUS/r in patients who may be at risk of
increased bleeding or who are receiving medications known to increase
the risk of bleeding.
APTIVUS does not cure HIV infection/AIDS or prevent the
transmission of HIV to others. Patients may continue to develop
opportunistic infections and other complications associated with HIV
Apart from the EU, APTIVUS has received U.S. marketing
authorization by the FDA and was launched there in June 2005.
Additional marketing authorizations from different countries have
been received or are expected.
About Boehringer Ingelheim
Boehringer Ingelheim is committed to the research and development
of novel antiretroviral agents. Apart from Aptivus(R) (tipranavir),
Viramune(R) (nevirapine) is a product of original research done at
Boehringer Ingelheim. VIRAMUNE was the first member of the
non-nucleoside reverse transcriptase inhibitor (NNRTI) class of
anti-HIV drugs on the market. The company is involved in basic
research in that area and is committed to improving HIV therapy by
providing physicians and patients with innovative antiretroviral
Boehringer Ingelheim is actively conducting clinical trial
programs to further evaluate APTIVUS and VIRAMUNE for the treatment
of HIV-1 infection. The APTIVUS clinical trial program is comprised
of ongoing and planned studies in more than 1,400
treatment-experienced patients. In addition to the POTENT study,
Boehringer Ingelheim is also conducting the SPRING trial to examine
the benefits of APTIVUS in an ethnically and racially diverse highly
treatment-experienced patient population. The VIRAMUNE clinical trial
program includes the ArTEN trial, which aims to compare the efficacy
and safety of VIRAMUNE dosed once or twice daily versus atazanavir
boosted with ritonavir in HIV-positive antiretroviral-naive patients.
For more information on Boehringer Ingelheim HIV Franchise, please
Please be advised
This release is from the Corporate Headquarters of Boehringer
Ingelheim and is intended for all international markets. This being
the case, please be aware that there may be some differences between
countries regarding specific medical information including licensed
uses. Please take account of this when referring to the material.
(1) Gazzard et al. Combined analysis of RESIST 96-week data:
durability and efficacy of tipranavir/r in treatment-experienced
patients; 8th International Congress on Drug Therapy in HIV
Infection; 12-16 November 2006, Glasgow, UK. Poster P23.
Web site: http://www.boehringer-ingelheim.com/hiv
ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.ch
Judith von Gordon, CD Communications, Boehringer Ingelheim,
+49-61-32-77-3582, or fax, +49-61-32-77-6601