NCT03730181 is a Phase 1, PHASE2 clinical trial of Rifapentine in Latent Tuberculosis, sponsored by Centers for Disease Control and Prevention.

Who is sponsoring NCT03730181?

NCT03730181 is sponsored by Centers for Disease Control and Prevention.

What drugs are being tested in NCT03730181?

Interventions in NCT03730181: Rifapentine, Isoniazid.

What condition does NCT03730181 study?

NCT03730181 studies Latent Tuberculosis.

Is NCT03730181 still recruiting?

NCT03730181 is currently completed. Last updated 3 June 2025.

Last reviewed 2025-06-03 · How we verify

NCT03730181

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tuberculosis Clinical Trials Consortium Study 35

Completed Phase 1, PHASE2 Last updated 3 June 2025

What this trial tests

Phase 1, PHASE2 trial testing Rifapentine in Latent Tuberculosis in 62 participants. Completed in 15 May 2025.

Timeline

12 October 2019

Primary endpoint
15 December 2024

15 May 2025

Quick facts

Lead sponsor	Centers for Disease Control and Prevention
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	62
Start date	12 October 2019
Primary completion	15 December 2024
Estimated completion	15 May 2025
Sites	1 location across South Africa

Drugs / interventions tested

Rifapentine (RIFAPENTINE) — full drug profile →
Isoniazid (ISONIAZID) — full drug profile →

Conditions studied

Latent Tuberculosis — all drugs for Latent Tuberculosis →

Sponsor

Centers for Disease Control and Prevention — full company profile →

Who can join

Adults 0 to 12, any sex, with Latent Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will require higher mg/kg rifapentine dosing than adults to achieve adult- exposures which are correlated with efficacy in trials of TB prevention. Investigators further hypothesize that rifapentine will be safe and well-tolerated in HIV-infected and uninfected children who require treatment for LTBI.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Updates on the Treatment of Drug-Susceptible and Drug-Resistant Tuberculosis: An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.
Saukkonen JJ, Duarte R, Munsiff SS, Winston CA, et al · · 2025 · cited 64× · PMID 40693952 · DOI 10.1164/rccm.202410-2096st
Clinical standards for the diagnosis, treatment and prevention of TB infection.
Migliori GB, Wu SJ, Matteelli A, Zenner D, et al · · 2022 · cited 55× · PMID 35197159 · DOI 10.5588/ijtld.21.0753
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.
Gupta A, Hughes MD, Garcia-Prats AJ, McIntire K, et al · · 2019 · cited 34× · PMID 31415563 · DOI 10.1371/journal.pmed.1002882
Pragmatic global dosing recommendations for the 3-month, once-weekly rifapentine and isoniazid preventive TB regimen in children.
Radtke KK, Hibma JE, Hesseling AC, Savic RM. · · 2021 · cited 5× · PMID 32703775 · DOI 10.1183/13993003.01756-2020
Children and providers' perspectives on once-weekly rifapentine and isoniazid TB preventive therapy.
Marthinus AJ, Wademan DT, Saule Z, Hirsch-Moverman Y, et al · · 2025 · cited 3× · PMID 39802236 · DOI 10.5588/ijtldopen.24.0250
Dolutegravir concentrations in children receiving 3-month weekly isoniazid and rifapentine (3HP) for tuberculosis prevention.
Madzime RJ, van der Laan L, du Toit S, Barnabas S, et al · · 2026 · PMID 41504451 · DOI 10.1128/spectrum.03303-25

Verify or expand the search:

Other trials of Rifapentine

Trials testing the same drug.

NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT06191692 — 1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam · Phase 3 · not yet recruiting
NCT06253715 — Shortened Regimen for Drug-susceptible TB in Children · Phase 3 · 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
NCT05454345 — Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment · Phase 3 · not yet recruiting

Other recruiting trials for Latent Tuberculosis

Currently open trials in the same condition.

NCT06526689 — Lung Innate Immunity and Microbiome After Tuberculosis Exposure · recruiting
NCT06022146 — TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts · Phase 3 · recruiting
NCT05411744 — One-month Latent Tuberculosis Treatment for Renal Transplant Candidates · Phase 4 · active not recruiting
NCT05412212 — Brief Educational Video for Patients Prescribed LTBI Treatment · NA · active not recruiting
NCT05022862 — Economic Incentives and vDOT for Latent Tuberculosis Infection · NA · recruiting

Other Centers for Disease Control and Prevention trials

Trials by the same sponsor.

NCT06962904 — CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults · Phase 1 · active not recruiting
NCT06485258 — CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults · Phase 1 · completed
NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2, PHASE3 · active not recruiting
NCT06045923 — Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV · recruiting
NCT06054269 — Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03730181 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centers for Disease Control and Prevention
Last refreshed: 3 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03730181.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing