HIV-1 infection MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Sponsors
Tibotec Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for this trial: 1. Subject was previously randomized in a DUET trial and completed at least 24 weeks of treatment. 2. The subject, with less than 48 weeks of treatment in a DUET trial, was virologically failing in a DUET trial. Failure is defined as: - not achieving a 1 log10 decrease from baseline in plasma viral load at Week 24, - viral rebound with 2 consecutive measurements at least 0.5 log10 above nadir at Week 24 or later. OR: The subject, with at least 48 weeks of treatment in a DUET trial, is in the opinion of the investigator, not responding well to his/her therapy. 3. Subject has voluntarily signed the informed consent form. 4. Subject can comply with the protocol requirements. 5. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments of the trial. 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. Use of disallowed concomitant therapy. 2. Any treatment-emergent condition or exacerbation of underlying condition during the DUET trial, which in the investigator’s opinion would likely compromise the subject’s safety or compliance with trial procedures. 3. Female of childbearing potential not using effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 30 days after the end of the trial (or after the last intake of investigational ARVs). 4. Heterosexually active male subject not using effective birth control methods during the trial and until 30 days after the end of the trial (or after last intake of investigational ARVs). 5. A grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis. 6. Any grade 4 toxicity according to the Division of AIDS (DAIDS) grading table, with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions, and grade 4 elevation of glucose in subjects with pre-existing diabetes. 7. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR > 1.5 or albumin 2.5 x ULN). 8. Subjects who had to be withdrawn from the DUET trials because of any of the mandatory withdrawal criteria of that trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC125 200 mg b.i.d. as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who have participated in a DUET trial (TMC125-C206 or TMC125-C216) and have met the definition of virologic failure at Week 24 or later in these trials.;Secondary Objective: The secondary objectives are: - to evaluate the antiviral effect of TMC125 200 mg b.i.d. as part of an optimized ART including TMC114/rtv over time, after virologic failure in a DUET trial; - to evaluate the immunological effect of TMC125 200 mg b.i.d. as part of an optimized ART including TMC114/rtv over time, after virologic failure in a DUET trial; - to evaluate changes in HIV-1 genotype and drug susceptibility over time.;Primary end point(s): The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC125 200 mg b.i.d. as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who have participated in a DUET trial (TMC125-C206 or TMC125-C216) and have met the definition of virologic failure at Week 24 or later in these trials. | — |
Countries
Belgium, France, Germany, Italy, Portugal, Spain
Outcome results
None listed