Dosing and Safety of Once-Weekly Rifapentine and Isoniazid for 12 Weeks for Tuberculosis Preventive Therapy in Children With and Without HIV: Protocol for a Phase I/II Open-Label, Exposure-Controlled, Dose-Finding, and Safety Study (Tuberculosis Trials Consortium Study 35)

Ingrid Courtney   ¹ , MSc ;   Meredith G Dixon   ² , MD ;   Louvina van der Laan   ¹ , PhD ;   Rada Savic   ³ , PhD ;   Belen Solans   ³ , PhD ;   Kelly Dooley   ⁴ , MD ;   Deron Burton   ² , MD ;   Shaun Barnabas   ⁵ , PhD ;   Avy Violari   ⁶ , MD ;   Kia Bryant   ² , MPH ;   Nigel Scott   ² , MS ;   Patrick Phillips   ³ , PhD ;   Erin Sizemore   ² , MPH ;   Wendy Carr   ² , PhD ;   Susan Purchase   ¹ , MD ;   Elri Nortier   ¹ , MD ;   Joh-Nell van der Westhuizen   ¹ , MD ;   Anne-Marie Demers   ¹ , MD ;   Anneke Hesseling   ^{1 *} , MD ;   Rosanna Boyd   ^{2 *} , PhD

¹ Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, Western Cape, South Africa

² Centers for Disease Control and Prevention, Division of Tuberculosis Elimination, Atlanta, GA, United States

³ Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, United States

⁴ Department of Medicine, Division of Infectious Diseases, Vanderbilt University, Nashville, TN, United States

⁵ Family Centre for Research with Ubuntu (FAM-CRU), Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, Western Cape, South Africa

⁶ Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, Gauteng, South Africa

*these authors contributed equally