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
Who is this study for? Persons living with HIV and in HIV-negative household contacts of recently diagnosed tuberculosis patients
What treatments are being studied? Rifapentine+Isoniazid
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: f
View:
• Age ≥ 13 years
• Weight \> 30 kg
• HIV-seropositive
• HIV viral load \<400 copies/mL, defined as virally suppressed, on an EFV or DTG-based ART regimen (see Section 3.6.2)
• Candidates must meet WHO criteria for receiving TPT
• Age ≥ 13 years
• Weight \> 30 kg
• HIV-negative
• Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB
• Candidates must meet WHO criteria for receiving TPT
Locations
Other Locations
India
The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS
RECRUITING
Pune
Indonesia
Yayasan KNCV - The Persahabatan Hospital, Jakarta
RECRUITING
Jakarta
Mozambique
Fundação Aurum (The Aurum Institute Mozambique)
RECRUITING
Chokwé
South Africa
The Aurum Institute: Gavin J Churchyard Legacy Centre
RECRUITING
Klerksdorp
Contact Information
Primary
Jayajothi Moodley
JMoodley@auruminstitute.org
+27826593766
Backup
Richard Chaisson
rchaiss@jhmi.edu
Time Frame
Start Date: 2023-07-19
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 1000
Treatments
Experimental: Group 1: People living with HIV infection without active TB
Experimental: Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
Related Therapeutic Areas
Sponsors
Leads: The Aurum Institute NPC
Collaborators: Johns Hopkins University