Tuberculosis Clinical Trials Consortium Study 35

Summary

Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will require higher mg/kg rifapentine dosing than adults to achieve adult- exposures which are correlated with efficacy in trials of TB prevention. Investigators further hypothesize that rifapentine will be safe and well-tolerated in HIV-infected and uninfected children who require treatment for LTBI.

Conditions

• Latent Tuberculosis

Interventions

DRUG

Rifapentine

Rifapentine. Initial dose will be 25mg/kg. Based on interim analysis, this may be adjusted throughout the study to achieve target exposures. The standalone water-dispersible rifapentine tablet may be used to adjust the rifapentine doses, if needed.

DRUG

Isoniazid

Isoniazid. 25mg/kg

Sponsors & Collaborators

• University of Stellenbosch

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Sanofi

  collaborator INDUSTRY

• University of Cape Town

  collaborator OTHER

• Chris Hani Baragwanath Academic Hospital

  collaborator OTHER

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Anneke Hesseling, MD · University of Stellenbosch

• Mark Cotton, MD · University of Stellenbosch

• Avy Violari, MD · PHRU

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

0 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-12

Primary Completion

2024-12-15

Completion

2025-05-15

FDA Drug

Yes

Countries

• South Africa

Study Locations