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 - ND

TIBOTEC PHARMACEUTICALS LTD.0 sites100 target enrollmentOctober 10, 2008

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 10, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

TIBOTEC PHARMACEUTICALS LTD.

Eligibility Criteria

Inclusion Criteria

•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 1000 HIV\-1 RNA copies/mL (assayed by Roche COBAS TaqMan). 7\. On a stable ART for at least 8 weeks at screening and willing to stay on that treatment until baseline. 8\. General medical condition, in the investigator?s opinion, does not interfere with the assessments and the completion of the trial.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•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 (Category C conditions according to the CDC Classification System for HIV infection 1993 or according to the 1994 revised CDC Classification System for HIV infection in children less than 13 years of age \[see Addendum 5, Section 7\.5 and Addendum 6, Section 7\.6]) with the following exceptions, which must be discussed with the Sponsor prior to enrolment: o 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; o 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. 6\. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject?s safety or adherence to the protocol; 7\. Any active clinically significant disease (e.g., tuberculosis (TB), cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator?s opinion, would compromise the subject?s safety or outcome of the trial; 8\. Acute viral hepatitis including but not limited to A, B or C; 9\. Subject enrolled in other clinical trials that include any blood sampling, specimen collection, or other interventional procedure. Concurrent participation in non\-interventional observational trials is allowed as long as there is no impact on the objectives of this trial. Note: Also during the conduct of the trial, subjects are not allowed to participate in any other clinical trial that include any blood sampling, specimen collection, or other interventional procedure. 10\. Receipt of any ARV or non\-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available and for which the use was discussed with and approved by the Sponsor; 11\. Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125\); 12\. Pregnant or breastfeeding female; 0201293, Final, 17\-Apr\-2008 21:40 TMC125\-TiDP35\-C213 Clinical Trial Protocol 22 13\. Sexually active boys, or girls who are sexually active and able to become pregnant, not using safe and effective birth control methods (see Section 5\.2\.4\) 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); 14\. Any grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading scale (see Addendum 9, Section 7\.9\), except for: Grade 3 absolute neutrophil count; Grade 3 platelets; Asymptomatic grade 3 pancreatic amylase elevation; Asymptomatic grade 3 triglyceride / cholest