Two
Expanded Access Programs Now Available to Provide Free Access to the Experimental
HIV Medications MK-0518 and TMC125 By
Ronald Baker, PhD Expanded
access programs (EAPs) provide patients with few treatment options a way to use
experimental medications as a part of their treatment regimen without being enrolled
in a clinical trial. EAPs allow HIV patients experiencing treatment failure access
to new therapies before they are approved by the FDA. Experimental
drugs in EAPs are available to patients outside of clinical trials in the following
circumstances: 
The medication is used to treat a serious or life-threatening disease that cannot
be properly managed with currently available therapies;
The medication is being studied in clinical trials or all clinical trials have
been completed;
The medication being studied in clinical trials shows adequate safety and efficacy
data.
The
Food and Drug Administration (FDA) reviews the clinical trial data to assure that
the medication is safe and effective before granting expanded access approval
to it. Currently
there are two promising new anti-HIV medications available through EAPs: MK-0518
and TMC 125. MK-0158 is a leading candidate in a new class of anti-HIV
drugs called integrase inhibitors. TMC125 is an experimental non nucleoside
reverse transcriptase inhibitor (NNRTI).
Articles on MK-0518 and
TMC 125 posted on HIV and Hepatitis.com:
MK-0518
Integrase Inhibitor Is Active Against HIV through 24 Weeks Free
Expanded Access Program Opens to MK-0518, Experimental HIV Integrase Inhibitor
from Merck
48-week
Data on TMC 125, a Next Generation Experimental NNRTI from Tibotec Pharmaceuticals
Combination
of Boosted Tipranavir and Experimental PI TMC 125 Is Not Recommended
Encouraging
Data at 13th CROI on Novel New HIV Protease Inhibitor TMC 114 and Unique Non Nucleoside
TMC 125
TMC
125,
a Next Generation NNRTI, Demonstrates Significant and Rapid Antiviral Activity
in Patients with High Levels of NNRTI Resistance Expanded
Access Program Opens for TMC 125
Expanded
Access Program (EAP) In the US
for TMC 125 (etravirine) Tibotec
has opened an Expanded Access Program (EAP) in the US for its investigational
non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC125 (etravirine). The
EAP will provide access for HIV-1 infected patients who need the drug to construct
a viable treatment regimen. TMC125
is currently in Phase III clinical trials (DUET 1 and DUET 2) in treatment-experienced
HIV patients. The safety & efficacy of TMC125 has not been established. The
US EAP is part of a larger, international early access program offered by Tibotec
Pharmaceuticals Ltd. The program will be administered by clinical affairs of local
operating entities within Johnson & Johnson, and will be supported by i3 Research
in North America. Who
can participate in the EAP? The
EAP is available to HIV positive affected adults who:
are 18 years of age or older
have limited or no treatment options due to virological failure or intolerance
to multiple ARV regimes
are unable to use currently approved NNRTIs due to resistance and or intolerance
have received licensed oral treatment from each of the 3 major classes of HIV
drugs (N(t)RTI, NNRTIs, PIs)
Note for PIs : 2 different PI-based regimens have been received
Note for NNRTI: primary NNRTI resistance can be included if experienced with at
least 2 classes of antiretrovirals (PIs, N(t)RTIs) and meet all the other inclusion
criteria
have no prior or current participation in DUET trials (TMC125-C206 or TMC125-C216)
How
to apply for participation? For
patients: As a patient, please discuss participation with your health care
professional. If you meet the eligibility criteria specified in the study protocol,
your health care professional can register as an EAP participating site and obtain
the investigational medication. For
health care professionals treating HIV patients: If
you are a healthcare professional and are interested in participating in the TMC125
EAP, you can apply for registration here. Your application will be reviewed by
a Representative of the Sponsor, and you will be informed of your eligibility
to participate in the EAP program. The required information to participate includes
the contact details of the PI as well as the address to which the investigational
medication is to be delivered. Upon acceptance of your registration, and validation
of the entered details, the site will be contacted by a Representative of the
Sponsor and will be informed of the next steps. Additional
information All
health care professionals and people living with HIV/aids may obtain information
by calling 1-866-889-2074, by emailing TMC125EAP@i3research.com
or visiting http://www.clinicaltrials.gov,
an FDA website with an overview of all clinical trial TMC
125 Expanded Access Program
The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients
Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information
on the Long-Term Safety and Tolerability of TMC125 Combined With Other Antiretroviral
Drugs.
This study is currently recruiting
patients.
Verified by Tibotec Pharmaceuticals Limited, Ireland August
2006 | Sponsored
by: Tibotec Pharmaceuticals Limited, Ireland | | Information
provided by: Tibotec Pharmaceuticals Limited, Ireland | | ClinicalTrials.gov
Identifier: NCT00354627 |
Purpose
The purpose of this study is to provide early access of TMC125 to HIV-1
infected patients who have failed multiple antiretroviral (ARV) regimens. Information
on safety and tolerability aspects of TMC125 in combination with other ARVs in
treatment-experienced HIV-1 patients with limited treatment options will be assessed.
Available data regarding the effectiveness of the drug will also be collected.
To
be eligible, patients should be failing their current ARV regimen or be on a treatment
interruption, should have previously received 2 different protease inhibitor (PI)
containing regimens and be at least 3-class experienced (protease inhibitors [PI],
nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside
reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs
and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination
with an investigator-selected background of additional ARVs from the list of allowed
medications. Condition:
HIV-1
Intervention Drug: TMC125
Phase: Phase III
Further
study details as provided by Tibotec Pharmaceuticals Limited, Ireland:
Primary
Outcomes: The primary objective of TMC125-C214 is to provide early access to TMC125
for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral
(ARV) regimens and have limited treatment options with currently approved ARVs.Secondary
Outcomes: The secondary objective of this trial is to gather information on the
safety and tolerability aspects of TMC125 in combination with other ARVs. Available
efficacy data will also be collected.
Study start Date: July 2006
This
is an open label trial with primary objective to provide early access to TMC125
for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral
(ARV) regimens and have limited treatment options with currently approved ARVs.
The secondary objective of this trial is to gather information on the
safety and tolerability aspects of TMC125 in combination with other ARVs. Available
efficacy data will also be collected. Patients should be at least 3-class experienced
or 2-class experienced with primary non-nucleoside reverse transcriptase inhibitor
(NNRTI) resistance.
They should also have previously received 2 different
protease inhibitor-based regimens (low-dose ritonavir is not counted as a protease
inhibitor (PI) regimen), be on a treatment interruption or not be virologically
suppressed on their current regimen, and not be able to use currently approved
NNRTIs due to resistance (primary or acquired) and/or intolerance.
Patients
must also meet all in- and exclusion criteria. TMC125 (200mg twice daily) will
be provided once the patient has been confirmed eligible for entry. Once treatment
with TMC125 in combination with other ARVs has been initiated, patients must be
instructed to follow the recommended visit schedule based on routine clinical
care.
Safety and tolerability of the entire antiretroviral therapy (ART)
regimen, including TMC125, should be monitored by the investigator as per standard
clinical practice. However, it is recommended that visits be planned 4 and 12
weeks following initiation of TMC125 in combination with other ARVs and every
12 weeks thereafter while on therapy during this trial.
Adverse events
(AEs) leading to treatment interruption or discontinuation and all serious adverse
events (SAEs), with the exception of Acquired Immunodefiency Syndrome (AIDS) defining
illnesses (CDC class C) unless fatal or considered to be related to TMC125, will
be collected. Other adverse events will be collected only if required as per local
regulations.
The background ARVs may be changed at any time during the
trial, at the discretion of the investigator due to the development of resistance,
intolerance, toxicity, etc. while continuing treatment with TMC125 if in the investigator's
assessment the patient still benefits from treatment with TMC125. If changes in
the background regimen are made, it is recommended that a follow-up visit be planned
4 weeks after the change in therapy.
Treatment with investigational medication
will be continued until virologic failure, treatment-limiting toxicity, subject
lost to follow-up, patient's withdrawal, pregnancy, discontinuation of TMC125
development or when TMC125 has become commercially available in the patient's
country.
Patients will be instructed to orally take two 100 mg tablets
of TMC125 following a meal every 12 hours. TMC125 (200 mg twice daily) must be
used in combination with other antiretroviral drugs. Treatment with investigational
medication will continue until virologic failure, treatment-limiting toxicity,
patient lost to follow-up, withdrawal, pregnancy, discontinuation of TMC125 development
or when TMC125 becomes commercially available in the patient's country.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study:
Both
Criteria
Inclusion Criteria: -
Patient is at least 3-class experienced (3 classes of licensed oral antiretrovirals:
nucleoside/tide reverse transcriptase inhibitors [N[t]RTI], protease inhibitors
[PI], non-nucleoside reverse transcriptase inhibitors [NNRTI])
- Patients
with primary NNRTI resistance can be included if they are experienced with at
least 2 classes of ARVs (PIs, N[t]RTIs) and meet all the other inclusion criteria
- Patient has previously received 2 different PI-based regimens
-
Patient is unable to use currently approved NNRTIs due to resistance (primary
or acquired) and/or intolerance
- Patient, if currently receiving an ARV
regimen, is not achieving adequate virologic suppression on his/her current regimen
-
Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216)
-
Use of disallowed concomitant therapy, including disallowed antiretrovirals (ARV)
- Any active clinically significant disease (e.g., cardiac dysfunction,
pancreatitis, acute viral infection) or findings during screening of medical history
or physical examination that is not either resolved or stabilized for at least
30 days before the Screening Phase
- Pregnant or breast-feeding female
- Female patient of childbearing potential not using effective non-hormonal
birth control methods
- Patients with specific laboratory abnormalities
- Patients with clinical or laboratory evidence of significantly decreased
hepatic function or decompensation
Location
and Contact Information
Please refer to this study by ClinicalTrials.gov
identifier NCT00354627
Use link at the bottom of the page to see if you qualify
for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com Alabama
Hobson City, Alabama, 36201, United
States; Not
yet recruiting
California Willard L. Maletz, Md Inc., Long
Beach, California,
90807, United States; Recruiting Williard Maletz 562-989-6847
Willard Maletz,
Principal Investigator
Connecticut
Norwich,
Connecticut, 06360, United
States; Not yet recruiting
Florida
Infectious Diseases Associates, Sarasota, Florida, 34239, United
States; Not yet recruiting Pat
Carr 941-366-0776
Vilma
Vega, Principal Investigator Wohlfeiler, Piperato & Associates
LLC, N. Miami Beach, Florida, 33169, United
States; Not yet recruiting Jaime
Lopez 305-944-2884
Michael Wohlfeiler,
Principal Investigator
Georgia
Family Healthcare
of Atlanta, P.C., Atlanta, Georgia,
30318, United
States; Not yet recruiting Sharon Fragale 404-355-2000
Mark Tanner, Principal
Investigator
Illinois
Chicago,
Illinois, 60610,
United States; Not
yet recruiting Chicagho, Illinois,
60657, United States; Not yet recruiting
Kentucky
Henderson, Kentucky, 42420, United
States; Not yet recruiting
Missouri
Southampton Healthcare, Inc., St.
Louis, Missouri,
63139, United States; Recruiting Michael
McGovern 314-647-2200
David Prelutsky,
Principal Investigator
New Jersey
Garden
State Infectious Diseases, Voorhees, New Jersey, 08043, United
States; Recruiting Dawn
Slowinski 856-566-3190
David Condoluci, Principal Investigator Newark, New Jersey, 07103, United
States; Not
yet recruiting
New York
New York Hospital Queens
- Cardiac Cath Lab 3RD Floor, Flushing, New York, 11355, United
States; Not yet recruiting Susan
Kiernan 718-670-2530
Sorana
Segal-Maurer, Principal Investigator New York, New York,
10011, United States; Not yet recruiting
Oregon
Portland,
Oregon, 97227,
United States; Not
yet recruiting
Texas
David Powell Clinic, Austin, Texas, 78751, United
States; Recruiting Rhonda
Ray 512-972-4901
KATHERINE BROWN,
Principal Investigator
Therapeutic Concepts, Houston, Texas, 77004, United
States; Not yet recruiting Kenneth
Degazon 713-526-9821
Joseph Gathe, Principal Investigator Study
chairs or principal investigators Tibotec Pharmaceuticals Limited Clinical Trial, Study Director, Tibotec
Pharmaceuticals Limited, Ireland
More
Information |
09/19/06 Sources
www.tibotec.com
www.clinicalTrials.org
s. | |
