An open-label trial of TMC125 in HIV-1 infected subjects who were randomized in any sponsor selected TMC125 trial to an active control arm and either virologically failed or completed the entire treatment period, or to placebo arm and were treated for at least 48 weeks. - N/A
- Conditions
- HIV-1 infection
- Registration Number
- EUCTR2004-001658-10-PT
- Lead Sponsor
- Tibotec Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
Subjects who meet all of the following criteria are eligible for this trial:
1. Subject has signed the Informed Consent Form (ICF) voluntarily;
2. Male or female subject, aged 18 years and above;
3. Subject having previously been randomized to an active control arm of a sponsor-selected TMC125 trial and has completed the entire treatment period or has met the definition of virological failure, as defined in the original protocol, before TMC125-C211 screening or subjects who were randomized in a fully blinded TMC125 trial, being unblinded after treatment for at least 48 weeks and identified as having received placebo;
4. Subject agrees to take TMC125 in combination with the investigator-selected combination therapy consisting of at least 2 drugs (NRTIs and/or allowed PI and/or T-20; low-dose ritonavir [= 400 mg daily dose] is not counted as a separate ARV);
5. Subject can comply with the protocol requirements;
6. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion 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
Subjects meeting one or more of the following criteria cannot be selected:
1. Use of disallowed concomitant therapy;
2. History of or currently active alcohol or substance use which would likely compromise the subject’s safety or compliance with the study procedures;
3. Any active clinically significant disease or findings during physical examination that would compromise the subject’s safety;
4. Pregnant or breastfeeding female;
5. Female subject of childbearing potential without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 14 days after the end of the trial (or the last intake of investigational medication):
Note: Hormonal based contraception may not be reliable when taking TMC125, therefore to be eligible for this study, women of childbearing potential should either:
(1) use a double barrier method to prevent pregnancy, or
(2) use hormonal based contraceptives in combination with a barrier contraceptive, or
(3) use an intra-uterine device in combination with a barrier contraceptive, or
(4) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner.
Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women who have a tubal ligation are considered of non-childbearing potential;
6. Renal impairment as defined by serum creatinine > 2 x upper limit of normal (ULN);
7. Any grade 3 or grade 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevations; or asymptomatic and isolated grade 3 or 4 elevations in gamma-glutamyl transferase [GGT] with all other liver enzymes and bilirubin within normal ranges, or isolated grade 3 elevation in amylase with no increase in lipase and no history of pancreatitis);
8. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio > 1.3 or albumin < 30 g/l or direct bilirubin > 2.5 x ULN).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC125;Secondary Objective: The secondary objectives are to evaluate the antiviral activity and immunological effect of TMC125 as part of an ARV regimen over time, and to evaluate genotypic and phenotypic changes over time.;Primary end point(s): The primary objective of the trial is to evaluate the long-term safety and tolerability of TMC125
- Secondary Outcome Measures
Name Time Method