At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
In Brief
A Phase 2 clinical trial evaluating Rilpivirine and ARV Background Regimen for HIV. Completed, enrolled 26 participants across 14 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.
The investigator-selected ARVs, including but not limited to N(t)RTIs (example, azidothymidine \[AZT\], abacavir \[ABC\], tenofovir alafenamide \[TAF\], or tenofovir disoproxil fumarate \[TDF\] in combination with emtricitabine \[FTC\] or lamivudine \[3TC\]), whichever are approved and marketed or considered local standard of care for children aged between 2 and \< 12 years in a particular country are to be administered. Integrase inhibitors (for example, dolutegravir \[DTG\] or raltegravir) can also be administered in combination with RPV, as appropriate.