At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label Trial, to Evaluate Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Drv/Rtv Once Daily in Treatment-Naive HIV-1 Infected Adolescents Aged Between 12 and < 18 Years
In Brief
A Phase 2 clinical trial evaluating darunavir, ritonavir, and 3 other interventions for HIV-1 Infection. Completed, enrolled 12 participants across 9 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ie, 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), in treatment-naive (never treated before) HIV-1 infected adolescents aged from 12 to \<18 years and weighing at least 40 kg.
Study Details
Timeline
Interventions
Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks
Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks
NRTI (zidovudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country
NRTI (lamivudine) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country
NRTI (abacavir) administered as per approved, marketed, or considered local standard of care for patients aged between 12 and \< 18 years in a particular country