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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01582711
Other study ID # CDC-NCHHSTP 6222
Secondary ID TBTC Study 33
Status Completed
Phase Phase 3
First received February 10, 2012
Last updated July 30, 2015
Start date September 2012
Est. completion date October 2014

Study information

Verified date July 2015
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug AdministrationSpain: Ministry of HealthSpain: Spanish Agency of MedicinesHong Kong: Department of HealthHong Kong: Ethics CommitteeSouth Africa: Human Research Ethics CommitteeSouth Africa: Medicines Control Council
Study type Interventional

Clinical Trial Summary

The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives:

- To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders

- To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion.

- To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study.

- To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually)

- To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms

- To collect patient-specific cost data related to the 3 treatment arms

- To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Self Administered Therapy (SAT)
Self Administered Therapy (SAT)
SMS reminders
Short Message Service (SMS) text reminders
Drug:
isoniazid and rifapentine
rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)

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Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Countries where clinical trial is conducted

United States,  China,  South Africa,  Spain, 

References & Publications (4)

Centers for Disease Control and Prevention (CDC). Recommendations for use of an isoniazid-rifapentine regimen with direct observation to treat latent Mycobacterium tuberculosis infection. MMWR Morb Mortal Wkly Rep. 2011 Dec 9;60(48):1650-3. Erratum in: MMWR Morb Mortal Wkly Rep. 2012 Feb 3;61:80. — View Citation

Shepardson D, Marks SM, Chesson H, Kerrigan A, Holland DP, Scott N, Tian X, Borisov AS, Shang N, Heilig CM, Sterling TR, Villarino ME, Mac Kenzie WR. Cost-effectiveness of a 12-dose regimen for treating latent tuberculous infection in the United States. Int J Tuberc Lung Dis. 2013 Dec;17(12):1531-7. doi: 10.5588/ijtld.13.0423. — View Citation

Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, Weis S, Ho C, Villarino ME; Tuberculosis Trials Consortium. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015 Aug 15;61(4):527-35. doi: 10.1093/cid/civ323. Epub 2015 Apr 22. — View Citation

Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment completion rate. Treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation. Up to 16 weeks from start of treatment. No
Secondary Treatment completion rates between the DOT arm and the SAT arm with SMS reminders Up to 16 weeks from start of treatment. No
Secondary Treatment completion rates between the DOT arm and the SAT arm without SMS reminders. Up to 16 weeks from start of treatment. No
Secondary Treatment completion rates between the SAT arm with SMS reminders and the SAT arm without SMS reminders. Up to 16 weeks from start of treatment. No
Secondary Rates of treatment discontinuation by category. Categories of treatment discontinuation include:
due to adverse events
due to patient choice
due to inability to locate patient
other
Up to 16 weeks from start of treatment. No
Secondary Rates of SMS reminders utilization. Up to 16 weeks from start of treatment. No
Secondary Rates of any drug-related grade 3, 4, or 5 adverse events between the DOT arm and the SAT arms (both combined and individually) Up to 20 weeks from start of treatment. Yes
Secondary Rates and timing of treatment discontinuations between the DOT arm and the SAT arms (both combined and individually). This includes discontinuations due to:
non-adherence
any adverse event (AE)
a diagnosis of active TB
other reasons
Up to 16 weeks from start of treatment. Yes
Secondary Cost of treatment (in USD or QALY) associated with adverse events between the DOT arm and the SAT arms (both combined and individually). Up to 20 weeks from start of treatment. No
Secondary Rates of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from patients who develop active TB between the DOT arm and the SAT arms (both combined and individually). up to 2 years from start of treatment. No
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