An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects, who participated in TMC278 clinical trials. - Open trial with TMC278 25mg in HIV-infected subjects until reimbursement

Janssen-Cilag0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•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.

•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.

发起方