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

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).