A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

• The number of participants affected by an adverse event [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
• Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

• Incidence of adverse events (AEs) considered at least possibly related to TMC278, serious AEs, AEs leading to discontinuation [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
• Any Division of AIDS (DAIDS) grade 3/4 rash [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]

• HIV RNA levels [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
• CD4+ cell count [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 [C204]) or Phase III trials (i.e., TMC278-TiDP6-C209 [C209] or TMC278-TiDP6-C215 [C215]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.

Inclusion Criteria:

• Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.
• Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.
• Patient can comply with the current protocol requirements.
• The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.

Exclusion Criteria:

• Use of disallowed concomitant therapy.
• 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 last intake of TMC278).
• Non-vasectomized heterosexually active male patients 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).