drugset / Trial / NCT01975012
Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age
Phase 1/2
Withdrawn
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Development of tolerable and effective antiretroviral (ARV) drugs for use in children and adolescents remains a high priority. First-line therapy with non-nucleoside reverse transcriptase inhibitors (NNRTIs) has proven to be effective for HIV-1-infected infants, children, and adolescents. This study will evaluate the safety, effectiveness, and dosing levels of the NNRTI rilpivirine (RPV) when given with two other ARV drugs in treatment-naive, HIV-1-infected children less than 12 years of age.
Timeline
- Start
- 2014-09
- Primary completion
- 2018-05
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilpivirine | Small molecule | 2.5 unknown | Oral |
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |