A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Phase 2 Completed 54 enrolled Janssen Sciences Ireland UC

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N\[t\]RTIs) (zidovudine \[AZT\], abacavir \[ABC\], or tenofovir disoproxil fumarate \[TDF\] in combination with lamivudine \[3TC\] or emtricitabine \[FTC\] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (\>=) 6 to less than (\<) 18 years.

Timeline

Start: 2011-01
Primary completion: 2022-08
Completion: 2022-08

Publications

Lombaard J, Ssali F, Thanyawee P, Fourie J, Vanveggel S, Linthicum C, Van Eygen V, Van Solingen-Ristea R. Phase 2 Open-Label Study of Long-Term Safety, Tolerability, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive Adolescents Living with HIV-1. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0091621. doi: 10.1128/AAC.00916-21. Epub 2021 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rilpivirine	Small molecule	25 mg	Oral
Background	Abacavir	Other / unclassified	—	Oral
Background	Lamivudine	Other / unclassified	—	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Background	Zidovudine	Small molecule	—	Oral
Background	emtricitabine	Other / unclassified	—	Oral

Indications

No indication recorded.