drugset / Trial / NCT04012931
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.
Timeline
- Start
- 2019-07-18
- Primary completion
- 2023-02-17
- Completion
- 2023-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rilpivirine | Small molecule | 25 mg | Oral |
| Background | Abacavir | Other / unclassified | — | — |
| Background | Dolutegravir | Other / unclassified | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Raltegravir | Other / unclassified | — | — |
| Background | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Background | azidothymidine | Unknown | — | — |
| Background | emtricitabine | Other / unclassified | — | — |
| Background | tenofovir alafenamide | Small molecule | — | — |