drugset / Trial / NCT00915655
A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents
Phase 2
Completed
12 enrolled
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceutical Limited · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-07
- Primary completion
- 2010-09
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Background | Abacavir | Other / unclassified | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Zidovudine | Small molecule | — | — |