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Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

NCT05118490

Active Not RecruitingPhase 4

Sponsor: The Aurum Institute NPC

Conditions: HIV Seropositivity, Tuberculosis, Household Contact

Interventions: Daily rifapentine and isoniazid for 4 weeks, Weekly rifapentine and isoniazid for 12 weeks

Countries: India, Indonesia, Mozambique, South Africa

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 overview

Sex: ALL

Age: 13 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (4)

Pune, Maharashtra, India
Jakarta, Jaya, Indonesia
Chokwé, Gaza Province, Mozambique
Klerksdorp, North West, South Africa