Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

Phase 1/2 Completed 56 enrolled Bristol-Myers Squibb

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to find the dose of Efavirenz for young children. The safety and how the medication is tolerated will also be studied.

Timeline

Start: 2007-02
Primary completion: 2011-12
Completion: 2013-07

Publications

Pavia-Ruz N, Rossouw M, Saez-Llorens X, Bunupuradah T, Taylor M, Yang R, Sevinsky H, Krystal M, Lataillade M, Seekins D, Biguenet S. Efavirenz Capsule Sprinkle and Liquid Formulations With Didanosine and Emtricitabine in HIV-1-infected Infants and Children 3 Months to 6 Years of Age: Study AI266-922. Pediatr Infect Dis J. 2015 Dec;34(12):1355-60. doi: 10.1097/INF.0000000000000913.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Efavirenz	Other / unclassified	—	Oral
Background	Didanosine	Small molecule	240 mg/m2	Oral
Background	emtricitabine	Other / unclassified	6 mg/kg	Oral

Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

Summary

Timeline

Publications

Drugs

Indications