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NCT06191692
1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
Phase 3 trial testing Isoniazid in Tuberculosis Infection in 350 participants. Not yet recruiting.
1 December 2026
Quick facts
| Lead sponsor | Freundeskreis Für Internationale Tuberkulosehilfe e.V |
|---|---|
| Phase | Phase 3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 350 |
| Start date | 1 August 2025 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2027 |
| Sites | 2 locations across Vietnam |
Drugs / interventions tested
- Isoniazid (ISONIAZID) — full drug profile →
- Rifapentine (RIFAPENTINE) — full drug profile →
- Rifampicin (Rifampicin) — full drug profile →
Conditions studied
- Tuberculosis Infection — all drugs for Tuberculosis Infection →
Sponsor
Freundeskreis Für Internationale Tuberkulosehilfe e.V
Who can join
18 and older, any sex, with Tuberculosis Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Introduction: Tuberculosis (TB) infection is a key driver of the TB pandemic, with over 10.6 million people fell ill with TB disease in 2022. About one-quarter of the global population is estimated to be infected with TB bacteria. Around 5-10% of people with TB infection will develop active and contagious TB disease, which could be largely avoided if TB infection is identified and given effective preventative treatment, before progression to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a higher treatment completion rate and increased uptake of preventative therapy for TB, as well as reduced side effects. Methods and analysis: An open-label, randomized clinical trial (1:1) will be performed in two study sites in Ha Noi, Vietnam (Vietnam National Lung Hospital and Ha Noi Lung Hospital). Adult household contacts (n=350) of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiate treatment will be invited to participate. Aim: To compare the TB preventive therapy completion rates and adverse event incidence between a new one-month regimen (1HP) versus the current three-month regimen (3HR)\*. \*1HP= one month of daily isoniazid (H/INH) and rifapentine (P/RPT) 3HR= three months of daily isoniazid (H/INH) and rifampicin (R/RIF)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06191692
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Related trials
Other trials of Isoniazid
Trials testing the same drug.
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- NCT06917495 — Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis · Phase 2 · not yet recruiting
- NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2 · recruiting
- NCT06253715 — Shortened Regimen for Drug-susceptible TB in Children · Phase 3 · recruiting
- NCT05994742 — An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM · Phase 3 · active not recruiting
Other recruiting trials for Tuberculosis Infection
Currently open trials in the same condition.
- NCT06352970 — Effects of Tuberculosis Infection on Development and Function of the Placenta · recruiting
- NCT06539455 — Analysis of Liver Injury Risk Factors in a Multiethnic Population Treated With Antituberculosis Drugs · active not recruiting
- NCT05122026 — Safety and Tolerability of 1 Month Daily (1HP) and 3 Months Weekly (3HP) Isoniazid and Rifapentine With Pharmacokinetics · Phase 1, PHASE2 · active not recruiting
- NCT06221488 — Testing Health Workers At Risk to Advance Our Understanding of TB Infection · recruiting
- NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
Other Freundeskreis Für Internationale Tuberkulosehilfe e.V trials
Trials by the same sponsor.
- NCT06916962 — Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial · NA · recruiting
- NCT06221735 — Evaluating the Accuracy of New Tests for TB Infection Diagnosis · NA · completed
- NCT06401434 — Evaluation of CAD-based Triage for CXR Interpretation During TB Screening · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06191692 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Last refreshed: 19 March 2025
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