TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

This study has the aim to continue the provision of DRV and rtv to pediatric patients that
continue to benefit from treatment with it after participation in any of three ongoing
pediatric studies sponsored by Tibotec Pharmaceuticals. In addition, information on the
safety of DRV and rtv in combination with other antiretroviral therapies will be assessed.
At the baseline visit, inclusion and exclusion criteria will be checked to confirm
eligibility. Once eligible, patients will continue treatment either on the once daily dose
regimen (when coming from the TMC114-TiDP29-C230 study) or a twice daily regimen (when
coming from the TMC114-C212 or TMC114-TiDP29-C228 studies). Assessments and visit frequency
will take place as per local standard of care but are desirable every 3 months. The
interval between two visits should not exceed 6 months. Pregnancy testing for girls having
had their first menses is foreseen. In addition, it is desirable that testing includes
efficacy assessments (immunology and plasma viral load) and laboratory safety assessments
(hematology, biochemistry including pancreatic amylase (if available) or lipase and lipid
analysis). Serious Adverse Events and certain selected Adverse Events will be collected.
Treatment will be continued until one of the following criteria is met (whichever occurs
first): Virologic failure, treatment limiting toxicity, loss to follow-up, withdrawal of
consent or assent by the patient or withdrawal of consent by the caregiver, pregnancy,
termination of the trial by the sponsor, when Darunavir becomes commercially available, is
reimbursed or can be accessed through another source (as there are access program or
government program) in the region the patient is living in. The sponsor advises
participating centers to plan the study visits every 3 months but frequency will depend on
local practice and standard of care. The sponsor has also foreseen in the study protocol a
guidance on specific safety assessments to be performed as well as detailed instructions on
how to deal with specific toxicities and undesirable effects. However local practice will
prevail and the assessments performed may vary depending on the region the patient is
participating in. Intake of study medication will happen once daily or twice daily,
depending on what the patient took in the original pediatric trial. For the twice daily
regimen, the regimen may be adjusted as the patient gains weight. The adult dosage regimen
of 600/100 mg DRV/rtv may be administered as of 40 kg of body weight. Depending on the
history of the patient, following dosages may be administered: DRV oral suspension (100mg
DRV/ml), DRV tablets 75 mg, 150 mg, 600 mg, all for twice daily intake. DRV 400 mg for the
once daily 800 mg intake (2 tablets per intake). DRV intake will be combined with rtv in
oral suspension (80 mg rtv/ml), capsule or tablet (both 100 mg)

Inclusion Criteria:

- Patient has completed the TMC114-C212, TMC114-TiDP29-C228 or TMC114-TiDP29-C230 study
and continues to benefit from DRV

- DRV is not commercially available, not reimbursed or cannot be accessed through
another way

- signed informed consent by parents/caregivers or assent by the patient is available
prior to inclusion

Exclusion Criteria:

- Any condition or active clinically significant disease (such as pancreas problems or
cardiac problems) endangering the patient safety while being enrolled in the study

- Previously demonstrated clinically significant allergy or hypersensitivity to the
study medication

- Pregnancy or breastfeeding female patients

- Specific criteria will be applicable for girls having had their first menses and for
girls and boys having reached the age of sexual activity