A Phase II, open label trial, to evaluate pharmacokinetics, safety, tolerability and antiviral activity of DRV in combination with low-dose ritonavir (DRV/rtv) in treatment-experienced HIV-1 infected children from 3 years to below 6 years of age

Tibotec Pharmaceuticals0 sites24 target enrollmentFebruary 25, 2014

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: The purpose of this Phase II trial is to evaluate the pharmacokinetics (blood levels), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs (ARVs), in treatment-experienced HIV 1 infected children aged from 3 years to < 6 years and weighing between 10 kg and < 20 kg .
Sponsor: Tibotec Pharmaceuticals
Enrollment: 24
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2014

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR\-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.); Body weight from 10 kg to \<20 kg at screening; Patients currently on stable ART (anti retroviral therapy) for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of \> 1000 copies/mL; Screening genotype resistance test results showing \< 3 DRV resistance\-associated mutations (RAMs);Parents or legal representative willing and able to give consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•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

•Patients with presence of any currently active conditions included in the listing of WHO ( World Health Organisation ) Clinical Stage 4 and patients with presence of a non\-HIV encephalopathy; Administration of any ARV (antiretroviral) 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 (Note:DRV should not be used within 14 days following the use of tipranavir); A minimal 14 day washout period is required in which tipranavir must be either interrupted or substituted to an investigator selected PI regimen until the baseline visit; Co\-enrollment in other clinical and/or cohort trials without written permission of the Sponsor; 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