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Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

NCT05118490 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-12-12

No results posted yet for this study

Summary

A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.

Conditions

Interventions

DRUG

Daily rifapentine and isoniazid for 4 weeks

Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)

DRUG

Weekly rifapentine and isoniazid for 12 weeks

Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)

Sponsors & Collaborators

Principal Investigators

  • Gavin Churchyard · Aurum Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2025-07-11
Completion
2025-12-31

Countries

  • India
  • Indonesia
  • Mozambique
  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05118490 on ClinicalTrials.gov