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.
- Disease/Condition
- Infections and Infestations; Infections and Infestations
- Intervention type
- drug
- Primary sponsor
- The Aurum Institute NPC
- Funder
- UNITAID
- Location
- South Africa
- Phase
- Phase 4
- Start date
- Jan 01, 1900
- End date
- Jan 01, 1900
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.
- Registry
- Pan Africa Clinical Trials Registry
- Trial ID
- PACTR202304463210784
- Type
- Non-Device Trial
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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