A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents. - Pediatric trial with Intelence as an Active NNRTI Option (PIANO)

Tibotec Pharmaceuticals Limited0 sites100 target enrollmentJuly 31, 2008

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Tibotec Pharmaceuticals Limited

•Subjects who meet all of the following criteria are eligible for this trial:
•1\. Male or female subjects, aged between 6 and 17 years, inclusive at signing of informed consent.
•2\. Body weight according to age within 10th to 90th percentile of the CDC growth chart for children.
•3\. Subjects (where appropriate, depending on age and local regulation) and their parent(s) or legal representative(s) willing and able to give consent. Children will be informed about the trial and asked to give assent.
•4\. Subjects with documented HIV\-1 infection.
•5\. Subject can comply with the protocol requirements.
•6\. HIV\-1 plasma viral load at screening visit above 500 HIV\-1 RNA copies/mL.
•7\. On a stable ART for at least 8 weeks at screening and willing to stay on that treatment until baseline.
•Note: Stable ART should comprise of a combination of at least 2 ARVs in line with the Pediatric Treatment Guidelines.
•8\. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.

•Subjects meeting 1 or more of the following criteria cannot be selected:
•1\. Evidence of resistance against TMC125 based on the resistance test performed at Screening. An up to date resistance interpretation will be provided to the investigator and can be used to determine eligibility in the trial.
•2\. Previously documented HIV\-2 infection.
•3\. Use of disallowed concomitant therapy.
•4\. Life expectancy of less than 6 months, according to the judgment of the investigator.
•5\. Presence of any currently active AIDS defining illness with the following exceptions, which must be discussed with the Sponsor prior to enrolment:
•\- Stable, cutaneous Kaposi Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period;
•\- Wasting syndrome due to HIV infection if, in the investigator’s opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the subject’s safety or compliance to adhere to the trial protocol procedures.
•\- An AIDS defining illness not clinically stabilized for at least 30 days will be considered as currently active.
•\- Primary and secondary prophylaxis for an AIDS defining illness is allowed in case the medication used is not part of the disallowed medication.