TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Children and Adolescents

This is an open label continued access trial for HIV-1 infected children or adolescents who
have completed treatment in a pediatric clinical trial with etravirine sponsored by or in
collaboration with Janssen Research & Development and who continue to benefit from the use of
etravirine. At the baseline visit, inclusion/exclusion criteria will be checked to confirm
eligibility. Once eligibility criteria are met, patients will either continue on the
etravirine dose they have received in the previous etravirine trial or on an adjusted dose if
deemed necessary by the investigator. Etravirine dose adjustment will be based on weight
using the dosing guidelines provided. Assessment visits are recommended every three months.
Adverse events leading to treatment interruption or discontinuation, adverse events at least
possibly related to treatment with etravirine, serious adverse events, and pregnancies will
be recorded at each visit. Treatment will be continued until one of the following criteria is
met: the investigator determines that the patient no longer benefits from etravirine
treatment (e.g., based on viral load); treatment limiting toxicity; loss to follow-up;
patient withdrawal of consent; pregnancy; termination of the program by the Sponsor;
etravirine becomes commercially available for pediatric use, is reimbursed, or can be
accessed through another source (e.g. access program, government program) in the region the
patient is living in, whichever occurs first. Patients will receive ETR, dosed as they have
received in the previous ETR trial, with weight based dose adjustment if necessary.

16 to < 20 kg :100 mg b.i.d.(4 tablets 25 mg b.i.d. or 1 tablet 100 mg b.i.d). 20 to < 25
kg:125 mg b.i.d.(5 tablets 25 mg b.i.d. or 1 tablet 100 mg + 1 tablet 25 mg b.i.d.) 25 to <
30 kg:150 mg b.i.d.(6 tablets 25 mg b.i.d. or 1 tablet 100 mg + 2 tablets 25 mg b.i.d).

= 30 kg: 200 mg b.i.d.(8 tablets 25 mg b.i.d. or 2 tablets 100 mg b.i.d)

Inclusion Criteria:

- Patients who meet all of the following criteria are eligible for this trial:
Documented HIV-1 infection

- Younger than 6 years of age are only allowed to participate after ETR dose
recommendations for that age group are available, and the sponsor has notified the
investigators, applicable Ethics Committees, and Health Authorities

- Successfully completed a clinical pediatric trial with ETR sponsored by or in
collaboration with Janssen Research & Development, and continues to receive benefit
from the use of ETR

- Patient (where appropriate, depending on age) and their parent(s) or legal
representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily

- Children will be informed about the program and asked to give assent (where
appropriate, depending on age)

- Negative urine pregnancy test for females of childbearing potential

Exclusion Criteria:

- Patients meeting one or more of the following criteria cannot be selected: Any
condition (including but not limited to alcohol and drug use), which in the opinion of
the investigator could compromise the patient's safety or adherence to treatment with
ETR

- Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or
findings of medical history, laboratory or physical examination that, in the
investigator's opinion, would compromise the patient's safety during treatment with
ETR

- Previously demonstrated clinically significant allergy or hypersensitivity to ETR or
to any of the excipients of ETR

- Pregnant or breastfeeding

- Non-vasectomized heterosexually active boys not using safe and effective birth control
methods, or not willing to continue practicing these birth control methods, during the
trial and until 30 days after the end of the trial (or after the last intake of the
investigational medication)

- Girls, who are sexually active and able to become pregnant, not using safe and
effective birth control methods, or not willing to continue practicing these birth
control methods, during the trial and until 30 days after the end of the trial (or
after the last intake of the investigational medication)