HIV-1 infection MedDRA version: 14.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Janssen R&D Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject or Legal Authorized Representative has voluntarily given informed con- sent 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: 1. Primary HIV infection. 2. Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216). 3. Any condition which, in the opinion of the investigator, could compromise the sub- ject’s safety or adherence to the protocol. 4. Use of disallowed concomitant therapy, including disallowed ARVs. 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 nonchildbearing potential. 11. Subjects with the following laboratory abnormalities as defined by a standard- ized grading scheme based on the Division of AIDS (DAIDS) grading table (up- dated version from December 2004, see Section 7.2): - Hemoglobin 1,5 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: Subje
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 ;Timepoint(s) of evaluation of this end point: - | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -;Timepoint(s) of evaluation of this end point: - | — |
Countries
Germany, Italy
Contacts
Public ContactJanssen Biologics BV
Janssen-Cilag International NV - Clinical Registry Group
Outcome results
None listed