PACTR202304463210784

1HP-3HP-AUR1-6-352 - 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, the “One to Three” 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, the “One to Three” trial.
The Aurum Institute NPC·Phase 4·Pan Africa Clinical Trials Registry·drugNot yet recruiting
Study focus
Intervention type
drug
Sponsor & location
Primary sponsor
The Aurum Institute NPC
Funder
UNITAID
Location
South Africa
Timeline & enrollment
Phase
Phase 4
Start date
Jan 01, 1900
End date
Jan 01, 1900
Summary

A multicenter, randomized, stratified, open label, phase IV trial among HIV-positive persons (PLHIV) on ART, or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary TB, who do not have evidence of active TB. Participants will be stratified by indication for TPT – HIV seropositive persons or HIV-negative household contact of person with infectious TB – and will receive either one of two TB preventive therapy regimens:Group 1: People living with HIV infection without active TB Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)Group 2: HIV-negative household contacts of newly diagnosed adults with rifampicin-sensitive pulmonary TB.Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)Trial Objective:To compare treatment success (adherence and completion of treatment) and safety of 1HP to 3HP in adolescents and adults who are living with HIV or are HIV-negative household contacts of an adult with confirmed pulmonary TB.

ICD-10 classifications
Certain infectious and parasitic diseasesInfestation, unspecifiedOther specified infestationsOther infestationsSequelae of infectious and parasitic diseases
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR202304463210784
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR202304463210784 through Pure Global AI's free database. This Phase 4 trial is sponsored by The Aurum Institute NPC and is currently Not yet recruiting. The study focuses on Infections and Infestations; Infections and Infestations.

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