An open-label trial with TMC125 in HIV-1 infected subjects, who were randomized to a TMC125 treatment arm in a sponsor-selected TMC125 trial and were treated for at least 48 weeks. - N/A
- Conditions
- HIV-1 InfectionMedDRA version: 9.1Level: LLTClassification code 10020192Term: HIV-1
- Registration Number
- EUCTR2005-000712-27-DE
- Lead Sponsor
- Tibotec Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Subjects who meet all of the following criteria are eligible for this trial:
1. subject voluntarily signed the informed consent ;
2. subject was previously randomized to a TMC125 treatment arm and completed at least 48 weeks of treatment with TMC125.
3. subject can comply with the protocol requirements;
4. 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 unless prior exemption has been granted;
2. any treatment-emergent condition or exacerbation of underlying condition during original Phase II trial, which in the investigator's opinion would likely compromise the subject's safety or compliance with the study procedures;
3. female or 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 after the last intake of ART);
Note : Hormone-based contraception may not be reliable when taking TMC125, therefore to be eligible for this study woman of childbearing potential should either:
(1) use a double barrier method to prevent pregnancy (i.e., using a condom with diaphragm or cervical cap; or
(2) use hormone-based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom); or
(3) use an intrauterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom); 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.
4. 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;
5. 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; grade 4 elevation of glucose in subjects with pre-existing diabetes.
6. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] > 1.5 or albumin < 30 g/l or 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 immunologic effect of TMC125 as part of an antiretroviral therapy over time, and to evaluate the genotypic and phenotypic changes over time.<br><br>;Primary end point(s): to evaluate the long-term safety and tolerability of TMC125
- Secondary Outcome Measures
Name Time Method