1HP-3HP-AUR1-6-352 - 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 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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202304463210784

Enrollment

1000

Registered

2023-04-24

Start date

2023-05-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

1HP with ARVs

3HP with ARVs

Not Applicable

Eligibility

Sex/Gender

All

Inclusion 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 EFV or DTG-based ART regimen (see Section 3.6.2) 5. Candidates must meet WHO criteria for receiving TPT

Exclusion criteria

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 T 10. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception** 11. On prohibited medications

Design outcomes

Primary

Measure	Time frame
(1) Successful completion of TPT with >90% adherence documented by self-report, pill count, and EMD reporting. (2) Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects. Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever.	—

Measure

Time frame

(1) Successful completion of TPT with >90% adherence documented by self-report, pill count, and EMD reporting. (2) Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects. Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever.

—

Secondary

Measure	Time frame
(1) Incremental cost-effectiveness of 1HP and 3HP (compared to each other, 6H, and no treatment) using a societal perspective.	—

Countries

South Africa

Contacts

Public ContactJayajothi Moodley

Programme Manager

jmoodley@auruminstitute.org+27826593766

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026