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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Aurum Institute NPC
• Collaborator: Johns Hopkins University
• Treatments: Isoniazid; Rifampin; Rifapentine

Criteria

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 efavirenz (EFV) or dolutegravir (DTG)-based ART regimen (see Section 3.6.2)

5. Candidates must meet national 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. Alanine aminotransferase (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