Weekly High dose Isoniazid and Rifapentine [P] Periodic Prophylaxis for TB

A randomised, prophylactic, open-label trial to evaluate the effect of three months of high dose Rifapentine plus Isoniazid administered as a single round or two consecutive rounds annually in HIV-positive individuals - WHIP3 TB study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/021923

Enrollment

2200

Registered

2019-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease

Interventions

Intervention1: A single round of weekly high dose rifapentine plus isoniazid for three months (3HP) for people living with HIV.: Rifapentine (at a maximum dose of 900 mg) plus isoniazid (at a maximum

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than 18 yea 2. Known HIV infection (On ART may serve as a proxy for HIV infection) 3. ART ineligible or on ART for >=3 months

Exclusion criteria

Exclusion criteria: 1. Confirmed or suspected TB disease. 2. Likely to move from the study area during the study period 3. Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case. • TB treatment within the past year. • TB preventive therapy within the last year. • Sensitivity or intolerance to isoniazid or rifamycins. • On nevirapine, etravirine, rilpivirine, or other PI-based or raltegravir-containing ART regimens. • Suspected acute hepatitis or known chronic liver disease. • ALT/AST >5 times the upper limit of normal (regardless of symptoms of hepatitis). • Pregnancy or breastfeeding. • Women of childbearing potential who are unable or unwilling to use contraception. • Self-reported alcohol use which might interfere with adherence to treatment.

Design outcomes

Primary

Measure	Time frame
Treatment completion is defined as 1. Proportion of participants in 3HP group self-reporting treatment completion of â?¥11 doses in a 16-week period 2. Proportion or participants in 6H group self-reporting treatment completion of â?¥167 doses over an 34 week (8-month) period Timepoint: 3HP arm- 16 weeks 6H arm- 34 weeks	—

Secondary

Measure	Time frame
Effectiveness will be defined by comparing incident TB cases meeting the definition for 1. Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive or smear-positive for M. tuberculosis from any site in adults and children 2. Clinical tuberculosis: Started on treatment for TB in adults and children Mortality is defined as death from any cause. Discontinuation of therapy will be evaluated as permanent discontinuation due to an adverse drug reaction Timepoint: 3HP and periodic 3HP- 24 months 6H- 12 months	—

Measure

Time frame

Effectiveness will be defined by comparing incident TB cases meeting the definition for 1. Confirmed tuberculosis: Culture-positive, Xpert MTB/RIF-positive or smear-positive for M. tuberculosis from any site in adults and children 2. Clinical tuberculosis: Started on treatment for TB in adults and children Mortality is defined as death from any cause. Discontinuation of therapy will be evaluated as permanent discontinuation due to an adverse drug reaction Timepoint: 3HP and periodic 3HP- 24 months 6H- 12 months

—

Countries

India

Contacts

Public ContactDr Prathiksha Giridharan

ICMR-National institute for research in Tuberculosis

prathiksha.g@nirt.res.in9677231205

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026