1 to 3 Trial

A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid for 3 Months (3HP) in Persons Living with HIV and in HIV-Negative Household Contacts of Recently Diagnosed Tuberculosis Patients

Background

Prevention of TB with Isoniazid Preventive Therapy (IPT) has been proven to be effective and can reduce morbidity and mortality, and has been the main TB prevention measure for several decades. However, for an intervention with sufficient scientific evidence of efficacy, global outcomes are far from adequate. IPT treatment completion rates are very low, dominated by the inability of patients to complete treatment.
Short duration combinations such as rifapentine (RPT) 900mg and isoniazid (INH) 900mg once a week for 3 months (3HP) and very short duration combinations once a day (1HP) consisting of RPT (600mg) and INH (300mg) for one month, more safe and has a higher treatment completion rate compared to IPT given 6-9 months. Although there is clinical evidence and recommendations for 1HP, no country with a high TB ​​burden has included 1HP in national TB or HIV treatment guidelines. Further clinical evidence is urgently needed to support the combination of very short duration TPT in this situation.

Information

The aim of this study is to compare treatment completion (treatment completion and compliance >90%) and safety of 1HP compared with 3HP in adolescent and adult household contacts of adult patients with new cases of pulmonary TB with negative HIV status.

 

Type of Study

Clinical Trial

(New Drug Regimen)

 

Topic

Tuberculosis

 

Collaborator

Aurum Institute Yayasan KNCV Indonesia