An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in HIV-1 infected subjects, who participated in TMC278 clinical trials - ND

• Conditions: HIV 1 INFECTION; MedDRA version: 9.1Level: LLTClassification code 10008922

• Registration Number: EUCTR2010-021209-18-IT
• Lead Sponsor: TIBOTEC PHARMACEUTICALS LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

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

Inclusion 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 continue to benefit from treatment with TMC278 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

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 or male condom with spermicide**, (2) intrauterine device or hormonal contraceptive, (3) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner, vasectomy should have been performed more than 6 months prior to trial initiation. * 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. ** a male and female condom should not be used together due to risk of breakage or damage caused by latex friction.

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 provide continued access to TMC278 for subjects who were randomized and treated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209 [ECHO] and TMC278-TiDP6-C215 [THRIVE]);Secondary Objective: The secondary objective is to evaluate the long-term safety and tolerability of TMC278 25 mg q.d. in combination with a background regimen containing 2 N(t)RTIs. Available efficacy data will also be collected;Primary end point(s): - provide continued access to TMC278 for subjects who were randomized and treated with TMC278 in the Phase IIb (e.g., TMC278-C204 [C204]) or Phase III trials (e.g., TMC278-TiDP6-C209 [ECHO] and TMC278-TiDP6-C215 [THRIVE]). - to evaluate the long-term safety and tolerability of TMC278 25 mg q.d. in combination with a background regimen containing 2 N(t)RTIs