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

Launched by THE AURUM INSTITUTE NPC · Nov 11, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatment options for preventing tuberculosis (TB) in people living with HIV and their household contacts who have been exposed to someone with TB. The trial will compare a one-month daily treatment of rifapentine and isoniazid (called 1HP) to a three-month weekly high-dose treatment of the same medications (called 3HP). The goal is to see which treatment is more effective in helping participants complete their medication and ultimately protect them from developing TB.

To be eligible for this study, participants must be at least 13 years old, weigh over 30 kg, and either be HIV-positive on specific medications or HIV-negative and living with someone who has recently been diagnosed with TB. Importantly, participants must not currently have active TB or have been treated for it in the past two years. Those who join the study can expect to receive the assigned treatment and will be monitored for their health and any side effects. This trial is currently looking for volunteers in South Africa, India, Mozambique, and Indonesia.

Gender

ALL

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