Active — Not RecruitingPhase 4

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

India, Indonesia, Mozambique1,000 participantsStarted 2023-07-19

Plain-language 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.

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 13 years
✓. Weight \> 30 kg
✓. HIV-seropositive
✓. HIV viral load \<400 copies/mL, defined as "virally suppressed," on an EFV or DTG-based ART regimen (see Section 3.6.2)
✓. Candidates must meet WHO criteria for receiving TPT

Exclusion criteria

✕. 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)
✕. Likely to move from the study area during the study period
✕. Known recent exposure to a TB case with resistance to isoniazid or rifampicin.
✕. Previous treatment for active or latent TB for more than 30 days within the past 2 years
✕. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
✕. Known sensitivity or intolerance to isoniazid or rifamycins
✕. Suspected acute hepatitis or known chronic or unstable liver disease\^
✕. ALT \> 3 times the upper limit of normal (ULN)

What they're measuring

Treatment adherence- self-report

Timeframe: 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

Treatment adherence- pill count

Timeframe: 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

Treatment adherence- electronic monitoring device (EMD)

Timeframe: 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

Adverse Events

Timeframe: from study entry at Day 0 through Month 6 (Week 24), to be reported at end of trial

Early treatment discontinuation

Timeframe: 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

Trial details

NCT IDNCT05118490

SponsorThe Aurum Institute NPC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-11

View on ClinicalTrials.gov More HIV Seropositivity trials

Who can participate

Age range13 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 13 years
✓. Weight \> 30 kg
✓. HIV-seropositive
✓. HIV viral load \<400 copies/mL, defined as "virally suppressed," on an EFV or DTG-based ART regimen (see Section 3.6.2)
✓. Candidates must meet WHO criteria for receiving TPT

Exclusion criteria

✕. 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)
✕. Likely to move from the study area during the study period
✕. Known recent exposure to a TB case with resistance to isoniazid or rifampicin.
✕. Previous treatment for active or latent TB for more than 30 days within the past 2 years
✕. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
✕. Known sensitivity or intolerance to isoniazid or rifamycins
✕. Suspected acute hepatitis or known chronic or unstable liver disease\^
✕. ALT \> 3 times the upper limit of normal (ULN)

What they're measuring

Treatment adherence- self-report

Timeframe: 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

Treatment adherence- pill count

Timeframe: 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

Treatment adherence- electronic monitoring device (EMD)

Timeframe: 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

Adverse Events

Timeframe: from study entry at Day 0 through Month 6 (Week 24), to be reported at end of trial

Early treatment discontinuation

Timeframe: 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