HIV-1 Infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: TMC125
Product Code: TMC125 F060
Pharmaceutical Form: Tablet
CAS Number: 269055-15-4
Current Sponsor code: TMC125
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
TIBOTEC PHARMACEUTICALS LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for this trial. 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 over 18 years of age. 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 2 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 on the current treatment). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria cannot be selected. 1. Primary HIV infection. 2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216). 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). 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. 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. 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): - Hemoglobin 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. 13.Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to provide early access to TMC125 for treatment-experienced HIV-1 infected subjects who have failed multiple ARV regimens and have limited treatment options with currently approved ARVs.;Secondary Objective: 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.;Primary end point(s): 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. Safety of TMC125 will be summarized in terms of -mortality -non-HIV related SAEs -subject's disposition. | — |
Countries
Italy
Outcome results
None listed