The primary objective of this trial is to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple ARV regimens and have limited treatment options with the currently approved antiretrovirals.The…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The trial is not set up to show a specific statistical hypothesis but to
provide TMC125 to ARV experienced HIV-1 infected subjects with limited
treatment options. Further objective is to gather information on safety and
tolerability aspects of TMC125.
Secondary outcome
Safety of TMC125 will be summarized in terms of
-mortality
-non-HIV related SAE's
-subject's disposition (reasons for discontinuation)
Background summary
Current options for the treatment of HIV-infected subjects consist of NRTI's,
NtRTI's, PI's and fusion-inhibitors.Currently, no single drug or combination
drug therapy is able to eradicate HIV-1. A triple drug regimen is considered
standard of care and when effective, results in suppression of the virus below
the detection limits of the current tests, thereby slowing the progression of
the disease and reducing the emergence of viral drug resistance.
There are patients who have failed multiple ARV regimens and have limited
treatment options with the currently approved antiretrovirals.
Study objective
The primary objective of this trial is to provide early access to TMC125 for
treatment-experienced HIV-1 infected patients who have failed multiple ARV
regimens and have limited treatment options with the currently approved
antiretrovirals.
The secondary objective of this trial is to gather information on the safety
and tolerability aspects of TMC125 in combination with other antiretrovirals.
Available efficacy data will also be collected.
Study design
International, multicenter, phase 3 study.
There is no controlgroup
Intervention
The patient receives two tablets of 100 TMC125 in combination with an
investigator-selected background of additional antiretrovirals from the list of
allowed medications.
Study burden and risks
The study consists of a screening period, treatment period and follow-up visit
(on average 4 to 5 consults per year).
The patient will be asked some questions about his/her medical history, current
medical condition and the medication taken.
The interventions are limited to a blood test and urine-sampling.
The venapunction and volume of blood taken are not necessary for the trial bur
are done as part of the standard of care in this patientpopulation.
Women are not allowed to become pregnant during and until 4 weeks after the end
of the trial. Women and men are asked ,during and until 4 weeks after the
trial, to use a good method of birth control. Beside this obligation nothing
else is requested and no other behaviour is mandatory.
In this trial patients who have failed multiple ARV regimens and have limited
treatment options with the currently approved antiretrovirals are treated. The
access to this trial medication in combination with a standard of care
treatment might offer new perspectives.
dr Paul Janssenweg 150
5026 RH Tilburg
Nederland
dr Paul Janssenweg 150
5026 RH Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
1. Subject or Legal Authorized Representative has voluntarily given informed consent before initiation of trial procedures.
2. Subject has documented HIV-1 infection.
3. Male or female subject (lower age limit 16 or 18 years of age, depending on local regulation)
4. Subject has limited treatment options due to virological failure or intolerance to multiple ARV regimens.
5. Subject is at least 3-class experienced (3 classes of licensed oral ARVs: N[t]RTIs, PIs, NNRTIs).
Note: Subjects 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.
6. Subject has previously received 1 different PI-based regimens.
7. Subject is unable to use currently approved NNRTIs due to resistance (primary or acquired) and/or intolerance.
8. Subject, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen (defined as a confirmed detectable plasma VL >or=50 copies/ml on the current treatment). A subject who does achieve adequate virologic suppression is only eligible if
*subject has treatment-limiting toxicity to an agent in his/her ARV regimen that requires substitution of this agent;
or
*subject is at risk of viral rebound and in the opinion of the investigator an intensification of the ARV regimen is appropriate;
or
*subject previously participated in another TMC125 clinical trial or program
Exclusion criteria
1. Primary HIV infection.
2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).This exclusion criterium was removed according to TMC125-C214-CTPA-GEN-II, dated 10 Oct 07.
3. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject*s safety or adherence to the protocol.
4. Use of disallowed concomitant therapy, including disallowed ARVs (See Section 5.3.8.2 protocol).
5. Use of non-ARV investigational medications within the 30 days prior to baseline visit.
6. Use of investigational ARVs, unless stated as an exception in Section 5.3.8.2.2. of the protocol
7. 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 of the trial.
8. Acute viral hepatitis, including but not restricted to A, B or C.
9. Pregnant or breast-feeding female.
10. Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
Note: Hormone based contraception may not be reliable when taking TMC125; therefore, to be eligible for this trial, women of childbearing potential who may have vaginal intercourse should either:
(1) Use a double barrier method to prevent pregnancy (i.e., use a condom without spermicide, with either a diaphragm or cervical cap) or
(2) Use hormone based contraceptives in combination with a barrier contraceptive (i.e., male condom without spermicide, diaphragm or cervical cap or female condom) or
(3) Use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom without spermicide, diaphragm or cervical cap or female condom) or
Note: The use of an IUD has been associated with an increased rate of sexually transmitted diseases.
(4) Be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
11. Subjects with the following laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) grading table (updated version from December 2004, see Section 7.2 van het protocol):
- Hemoglobin < 7.4 g/dL (4.5 mmol/L)
- Absolute neutrophil count < 500/mm³ (0.500 x 109/L)
- Platelets <25,000/mm3 (25.000 x 109/L)
- Prothrombin time (PT) >1.50 x upper limit of laboratory normal range (ULN)
Note: Subjects on anticoagulant therapy with elevated PT >1.5 ULN require approval of the sponsor prior to enrollment.
- Alkaline phosphatase >5 x ULN
- Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >5 x ULN
- Bilirubin > 5 x ULN
Note: Subjects with elevated bilirubin >5xULN assessed as related to a component of ART therapy may be enrolled with prior approval of the sponsor.
- Lipase >3 x ULN
- Amylase >5 x ULN if lipase >2 x ULN
- Creatinine >1.8 x ULN
12. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels.
Note: Subject can be included with prior approval of the sponsor if the elevated bilirubin (grade 3 or less) is assessed at the time of screening as related to an administered ARV and not to liver disease.
Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is judged to be clinically stable. Subjects diagnosed with acute viral hepatitis at screening will not be allowed in the trial.
13. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2006-002499-16-NL |
CCMO | NL14875.078.06 |