A Phase II, open-label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV/rtv once daily in treatment-naïve HIV 1 infected adolescents aged between 12 and < 18 years. - DIONE

Tibotec Pharmaceuticals0 sites12 target enrollmentMay 28, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 28, 2009

End Date

March 31, 2011

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who meet all of the following criteria are eligible for this trial.
•1\. Male or female adolescents, aged between 12 and \< 18 years at screening.
•2\. Subjects with a documented HIV\-1 infection.
•3\. Body weight from at least 40 kg at screening.
•4\. Screening plasma HIV\-1 RNA \= 1000 copies/mL.
•5\. Subjects qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines.
•Note: Current treatment guidelines recommend considering initiation of ART when CD4\+ cell counts are below 350 cells/µL. However, clinical situations may warrant initiating ART with CD4\+ cell counts above 350 cells/µL. Examples of such situations would include rapidly declining CD4\+ cell counts over time, high plasma viral load, history of AIDS\-defining illnesses or severe symptoms of HIV infection.
•6\. Parents or legal representative and trial subjects (where appropriate, depending on age and local regulation) willing and able to give consent and assent.
•7\. Subjects can comply with the protocol requirements.
•8\. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.

•Subjects meeting one or more of the following criteria cannot be selected.
•1\. Subjects with presence of any currently active conditions included in the listing of WHOClinical Stage 4\.
•2\. 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 trial protocol.
•3\. Previous or current use of ARVs (including both investigational as well as commercially available ARVs indicated for the treatment of HIV\-infection and ARVs for treatment of hepatitis B infection with anti\-HIV activity, e.g., adefovir, lamivudine, emtricitabine, entecavir).
•Note: Female adolescents who used a single dose of 200 mg of nevirapine to prevent MTCT are allowed in the trial, as long as they have never received other ARVs. Female adolescents who used zidovudine to prevent MTCT will not be allowed as this may result in reduced susceptibility to the ARV background regimen.
•Note: Subjects treated for postexposure prophylaxis will not be allowed.
•4\. Primary or acute HIV infection.
•5\. Use of any investigational agents within 30 days prior to screening.
•6\. Use of disallowed concomitant therapy.
•7\. Life expectancy less than 6 months, according to the judgment of the investigator.