roll-over trial for continued TMC278 access

Phase 1

• Conditions: HIV-1 infection; MedDRA version: 14.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2010-021209-18-NL
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-03
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

To be eligible, subjects must satisfy all of the following criteria:
1. Male or female subjects, aged 18 years or older.
2. Subjects must have signed an informed consent form (ICF) indicating that they are willing to participate in the trial and understand the purpose and procedures required for the trial.
3. Subjects are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol defined treatment period.
4. Subjects benefit from treatment with TMC278 according to the efficacy and safety criteria as set out in the previous protocol, and will continue to benefit from this treatment in the opinion of the investigator.
5. Subjects can comply with the current protocol requirements.
6. The subject's general medical condition, in the investigator's opinion, does not interfere with participation in 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

Potential subjects who meet any of the following criteria will be excluded from participating in
the trial:
1. Use of disallowed concomitant therapy (see Section 8).
2. Females of childbearing potential* who are pregnant, or 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 1 month after the end of the trial (or after last intake of TMC278).
Effective birth control methods**:
(1) male condom*** in combination with diaphragm or cervical cap **** (double barrier method”),
(2) intrauterine device or hormonal contraceptive in combination with a barrier contraceptive (i.e., male or female condom***, diaphragm, or cervical cap****),
(3) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner; if no other effective birth control methods are being used, vasectomy should have been performed more than 1 month prior to withdrawal of these other effective birth control methods.
* Women who are postmenopausal for at least 2 years, women with total hysterectomy and women who have a bilateral tubal ligation are considered of non-childbearing potential.
** Spermicides should not be used as this can potentially increase the rate of HIV-1 transmission.
** A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
**** A cervical cap has been shown to be less effective in parous women. Therefore, this barrier method is preferably not used in parous women in this trial.
3. Non-vasectomized heterosexually active male subjects 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 1 month after the end of the trial (or after last intake of TMC278).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified