Tuberculosis Clinical Trial
— 1 to 3Official title:
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 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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility | Group 1: HIV-positive adolescents and adults in South Africa and India Inclusion criteria: 1. Age = 13 years 2. Weight > 30 kg 3. HIV-seropositive 4. HIV viral load <400 copies/mL, defined as "virally suppressed," on an EFV or DTG-based ART regimen (see Section 3.6.2) 5. Candidates must meet WHO criteria for receiving TPT Exclusion criteria: 1. Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease) 2. Likely to move from the study area during the study period 3. Known recent exposure to a TB case with resistance to isoniazid or rifampicin. 4. Previous treatment for active or latent TB for more than 30 days within the past 2 years 5. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens 6. Known sensitivity or intolerance to isoniazid or rifamycins 7. Suspected acute hepatitis or known chronic or unstable liver disease^ 8. ALT > 3 times the upper limit of normal (ULN) 9. Total bilirubin > 2.5 times the ULN 10. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception** 11. On prohibited medications (see Appendix I) Group 2: HIV-negative household contacts of an adult with confirmed pulmonary TB in Mozambique and Indonesia Inclusion criteria: 1. Age = 13 years 2. Weight > 30 kg 3. HIV-negative 4. Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB 5. Candidates must meet WHO criteria for receiving TPT Exclusion criteria: 1. Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease) 2. Likely to move from the study area during the study period 3. Known exposure to TB cases with resistance to isoniazid or rifampicin in the source case 4. Previous treatment for active or latent TB for >30 days within the past 2 years 5. Known sensitivity or intolerance to isoniazid or rifamycins 6. Suspected acute hepatitis or known chronic or unstable liver disease^ 7. ALT > 3 times the upper limit of normal (ULN) 8. Total bilirubin > 2.5 times the ULN 9. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception** 10. On prohibited medications |
Country | Name | City | State |
---|---|---|---|
India | The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS | Pune | Maharashtra |
Indonesia | Yayasan KNCV - The Persahabatan Hospital, Jakarta | Jakarta | Jaya |
Mozambique | Fundação Aurum (The Aurum Institute Mozambique) | Chokwé | Gaza |
South Africa | The Aurum Institute: Gavin J Churchyard Legacy Centre | Klerksdorp | North West Province |
Lead Sponsor | Collaborator |
---|---|
The Aurum Institute NPC | Johns Hopkins University |
India, Indonesia, Mozambique, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment adherence- self-report | Completion of TPT with >90% adherence documented by self-report (both groups, Arms A and B) | from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial | |
Primary | Treatment adherence- pill count | Completion of TPT with >90% adherence documented by pill count (both groups, Arms A and B) | from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial | |
Primary | Treatment adherence- electronic monitoring device (EMD) | Completion of TPT with >90% adherence documented by pill count (both groups, Arms A and B) | from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial | |
Primary | Adverse Events | Occurrence of Grade 2 or higher targeted safety events (both groups, Arms A and B). Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever. | from study entry at Day 0 through Month 6 (Week 24), to be reported at end of trial | |
Primary | Early treatment discontinuation | discontinuation of study medications because of side effects (both groups, Arms A and B) | from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2), to be reported at end of trial | |
Secondary | Cost-effectiveness | Incremental cost-effectiveness of 1HP and 3HP (compared to each other, ^ months of isoniazid (6H), and no treatment) using a societal perspective. | from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial |
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