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Risk of SDRs Under 3HP and 1HP Regimen for LTBI

NCT04094012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2023-12-26

No results posted yet for this study

Summary

Successful implement of preventive therapy for subjects with latent tuberculosis infection (LTBI) is the critical step for elimination of tuberculosis (TB). The major obstacle of traditional preventive therapy is the unacceptable long treatment duration, taking isoniazid 5mg/kg daily for a total of 9 months (9H), thus seriously compromising its acceptability. With the introduction of 12-doses weekly high-dose (15 mg/kg) rifapentine plus isoniazid (3HP regimen), the completion rate of 3HP has be shown to be much higher than 9H. However, 4.9% to 9.1% of LTBI cases who received 3HP failed to complete treatment because of side effects. Systemic drug reactions (SDRs), even hypotension and shock, under 3HP treatment are higher than 9H treatment.

A recent study in HIV patients demonstrated that a new short-term regimen, consisting of isoniazid 5mg/kg plus rifapentine 10mg/kg daily for one month (1HP), has a similar risk of adverse reactions as 3HP. Clinical study with head-to-head comparison between 3HP and 1HP, however, remains lacking.

The prospective multicenter study is conducted to investigate whether risk of SDRs under 1HP is lower than that under 3HP.

Hypothesis: 1HP has a lower incidence rate of SDRs than 3HP

Objectives:

1. To compare the risk of SDRs in 1HP treatment and in 3HP treatment
2. To explore side effect profile of 1HP

Methods:

This multicenter randomized control trial will compare the risk of SDRs under conventional 3HP regimen (Arm 1: 3HP), and a new regimen consisting of daily rifapentine (10 mg/kg) plus isoniazid (5 mg/kg) for 1 month (Arm 2: 1HP).

Conditions

  • Latent Tuberculosis Infection

Interventions

DRUG

isoniazid and rifapentine

This prospective multicenter randomized control trial (RCT) will be conducted on LTBI cases (see 2. Study population) to compare the risk of SDRs under conventional 3HP regimen (Arm 1: 3HP) and a new regimen consisting of daily RPT (10 mg/kg) plus INH (5 mg/kg) for 1 month (Arm 2: 1HP)

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Jann-Yuan Wang, MD, PhD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2023-10-08
Completion
2023-12-15

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094012 on ClinicalTrials.gov