A Phase I, open-label trial to investigate pharmacokinetics, safety and tolerability of TMC125 at steady-state in treatment-experienced HIV-1 infected children.

Tibotec Pharmaceuticals Ltd0 sites42 target enrollmentJuly 22, 2006

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Tibotec Pharmaceuticals Ltd
Enrollment: 42
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 22, 2006

End Date

February 27, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Tibotec Pharmaceuticals Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Boys and girls \= 6 and \= 17 years old.
•2\. Subjects with documented HIV\-1 infection.
•3\. Subjects weighing \= 20 kg and with weight \< P90 according to the CDC growth charts
•4\. Being able to swallow the TMC125 tablet(s).
•5\. Subjects currently on a stable regimen of least 2 NRTIs and LPV/rtv with or without ENF (at approved pediatric doses) for at least 2 months who are not expected to change their regimen in the next 15 days and with a VL \< 50 copies/mL on 2 consecutive determinations (last VL measurement in medical file \+ screening VL measurement, should be taken at least 1 month apart).
•6\. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent. Children will be informed about the trial, and asked to give positive assent
•7\. Subjects can comply with the protocol requirements. Parents or legal representatives of the subjects will be instructed by the investigator to adequately supervise the subject’s protocol adherence.
•8\. General medical condition, in the investigator’s opinion, does not interfere with the
•assessments and the completion of the trial.
•9\. Sexually active boys, or girls who are sexually active and able to become pregnant, must either practice sexual abstinence during the trial or use a safe and effective birth control method such as a double barrier method of contraception (i.e., using a condom with either spermicidal cream/foam/gel or diaphragm or cervical cap) or hormone\-based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap with spermicide or female condom with spermicide) during the trial. Hormonal birth control alone is not considered to be adequate.

Exclusion Criteria

•1\. Use of disallowed concomitant therapy
•2\. History or current use of alcohol (more than 2 units per day), barbiturates, amphetamines, recreational or narcotic drugs, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures.
•3\. Life expectancy of less than 6 months according to the judgment of the investigator.
•4\. Presence of any currently active AIDS defining illness (Catergory 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
•Note: An AIDS defining illness not clinically stabilized for at least 30 days will be
•considered as currently active.
•Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in cases where the medication administered is not part of the disallowed medications 5\. Any active clinically significant disease (e.g. TB, malignancies, cardiac dysfunction,
•pancreatitis, acute bacterial or 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.
•6\. Subjects with history or at risk of bleeding disorders.