Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT (iAdhere)
This study is currently recruiting participants.
Verified October 2012 by Centers for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01582711
First received: February 10, 2012
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Latent Tuberculosis Infection |
Behavioral: Self Administered Therapy (SAT) Behavioral: SMS reminders Drug: isoniazid and rifapentine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | TBTC Study 33. An Evaluation of Adherence to Latent Tuberculosis Infection (LTBI) Treatment With 12 Doses of Once Weekly Rifapentine (RPT) and Isoniazid (INH) Given as Self-administered (SAT) Versus Directly-observed Therapy (DOT): iAdhere. |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- Treatment completion rate. [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Treatment completion rates between the DOT arm and the SAT arm with SMS reminders [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]
- Treatment completion rates between the DOT arm and the SAT arm without SMS reminders. [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]
- Treatment completion rates between the SAT arm with SMS reminders and the SAT arm without SMS reminders. [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]
- Rates of treatment discontinuation by category. [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]
Categories of treatment discontinuation include:
- due to adverse events
- due to patient choice
- due to inability to locate patient
- other
- Rates of SMS reminders utilization. [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: No ]
- Rates of any drug-related grade 3, 4, or 5 adverse events between the DOT arm and the SAT arms (both combined and individually) [ Time Frame: Up to 20 weeks from start of treatment. ] [ Designated as safety issue: Yes ]
- Rates and timing of treatment discontinuations between the DOT arm and the SAT arms (both combined and individually). [ Time Frame: Up to 16 weeks from start of treatment. ] [ Designated as safety issue: Yes ]
This includes discontinuations due to:
- non-adherence
- any adverse event (AE)
- a diagnosis of active TB
- other reasons
- Cost of treatment (in USD or QALY) associated with adverse events between the DOT arm and the SAT arms (both combined and individually). [ Time Frame: Up to 20 weeks from start of treatment. ] [ Designated as safety issue: No ]
- 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). [ Time Frame: up to 2 years from start of treatment. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 3HP Directly Observed Therapy (DOT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
|
Drug: isoniazid and rifapentine
rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
Other Names:
|
|
Experimental: 3HP Self Administered Therapy (SAT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
|
Behavioral: Self Administered Therapy (SAT)
Self Administered Therapy (SAT)
Other Name: SAT
Drug: isoniazid and rifapentine
rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
Other Names:
|
|
Experimental: 3HP SAT with SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
|
Behavioral: Self Administered Therapy (SAT)
Self Administered Therapy (SAT)
Other Name: SAT
Behavioral: SMS reminders
Short Message Service (SMS) text reminders
Other Names:
Drug: isoniazid and rifapentine
rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and non-pregnant, non-nursing females
- Age > 18 years
- Weight > 45kg and considered appropriate to receive RPT 900mg and INH 900mg once weekly by the local site investigator
- Willingness to provide signed informed consent.
- Clinical indication for LTBI treatment such as: 1) persons with a positive tuberculin skin test (TST) as defined by CDC criteria or a positive interferon-gamma release assay (IGRA) defined per the manufacturers' guidelines AND one of the following: close contact to someone with culture confirmed TB, HIV infection, or > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of TB treatment; 2) TST or IGRA converters defined as a documented change from negative to positive within a two-year period; 3) Persons with any other clinical indication for LTBI treatment as locally defined including persons with a negative TST and/or IGRA (e.g. HIV-infected close contacts to an active pulmonary TB cases)
Exclusion Criteria:
- Confirmed or suspected active TB
- Contacts to a source case with known resistance to isoniazid or rifampin
- Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB, regardless of whether the course was completed, because adherence may be different in people who previously took TB treatment
- Persons who are not considered candidates for SAT by the local investigator
- History of sensitivity or intolerance to isoniazid or rifamycins
- Serum alanine aminotransferase (ALT, SGPT) > 5x upper limit of normal among persons in whom an ALT is determined
- Persons with HIV-infection who 1) have a CD4 < 350 or 2) are currently receiving or planning to receive antiretroviral therapy in the first 120 days after study initiation (e.g., HIV-1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582711
Contacts
| Contact: Andrey S Borisov, MD, MPH | 404-639-8056 | ABorisov@cdc.gov |
Locations
| United States, California | |
| University of California, San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Payam Nahid, MD, MPH 415-206-5464 pnahid@ucsf.edu | |
| United States, Colorado | |
| Denver Public Health Department | Recruiting |
| Denver, Colorado, United States, 80204 | |
| Contact: Robert Belknap, MD 303-602-7244 Robert.Belknap@dhha.org | |
| United States, District of Columbia | |
| Washington DC Veterans Affairs Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| Contact: Debra Benator, MD 202-745-8000 debra.benator@va.gov | |
| Contact: S. Sonia Qasba, MD 240-777-1800 Sonia.Qasba@montgomerycountymd.gov | |
| United States, New York | |
| Columbia University College of Physicians and Surgeons and New York City Department of | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Neil Schluger, MD 212-305-9817 11@columbia.edu | |
| Contact: Joseph Burzynski, MD (212)368-1500 jburzyns@health.nyc.gov | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27713 | |
| Contact: Carol Dukes Hamilton, MD, MHS 919-544-7040 chamilton@fhi360.org | |
| Contact: Jason Stout, MD, MHS (919)668-0826 stout002@mc.duke.edu | |
| United States, Tennessee | |
| Vanderbilt University Medical Center and Nashville Metro Public Health Department | Recruiting |
| Nashville, Tennessee, United States, 37232-0146 | |
| Contact: Timothy Sterling, MD 615-343-0193 timothy.sterling@vanderbilt.edu | |
| United States, Texas | |
| University of North Texas Health Science Center at Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104-4802 | |
| Contact: Michel Fernandez, MD 817-321-4948 Michel.Fernandez@unthsc.edu | |
| Contact: Stephen Weis, DO (817)321-4937 Stephen.Weis@unthsc.edu | |
| South Texas - Department of State Health Services | Recruiting |
| San Antonio, Texas, United States, 78229-4404 | |
| Contact: Marc Weiner, MD 210-617-5300 weiner@uthscsa.edu | |
| Contact: Richard Wing, MD (956)423-0130 Richard.Wing@dshs.state.tx.us | |
| Audie L. Murphy VA Hospital | Recruiting |
| San Antonio, Texas, United States, 78229-4404 | |
| Contact: Marc Weiner, MD 210-617-5300 WEINER@UTHSCSA.EDU | |
| Brazil | |
| Hospital Universitario Clementino Fraga Filho - Rio de Janeiro, Brazil and Johns Hopkins | Not yet recruiting |
| Rio de Janeiro, Brazil, 21941-913 | |
| Contact: Marcus Conde 55-21-25622432 marcusconde@hucff.ufrj.br | |
| Contact: Fernanda Mello 55-21-25622432 fcqmello@hucff.ufrj.br | |
| China | |
| TB and Chest service of Hong Kong | Not yet recruiting |
| Hong Kong, China | |
| Contact: Chi-Chiu Leung, MBBS 852-97101028 cc_leung@dh.gov.hk | |
| Contact: Kwok-Chiu Chang, MBBS, MSc 852-25911147 kc_chang@dh.gov.hk | |
| South Africa | |
| Wits Health Consortium | Not yet recruiting |
| Soweto, South Africa | |
| Contact: Neil Martinson, MD +27 (11) 989-9729 martinson@phru.co.za | |
| Spain | |
| Agencia de Salut Publica - Barcelona, Spain and UNTHSC | Not yet recruiting |
| Barcelona, Spain, 08023 | |
| Contact: Joan Cayla, MD, MPH 0034 93 -238- 4555 jcayla@aspb.cat | |
| Contact: Jose Maria Miro, MD, MPH (0034) 93-227-5586 miro@medicina.ub.es | |
Sponsors and Collaborators
Investigators
| Study Director: | Andrey S Borisov, MD, MPH | U.S. Centers for Disease Control and Prevention (CDC), Atlanta, USA. |
| Study Chair: | Robert Belknap, MD | Division of Infectious Diseases, University of Colorado, Denver, USA. |
| Principal Investigator: | Robert Belknap, MD | Division of Infectious Diseases, University of Colorado, Denver, USA. |
More Information
Additional Information:
Publications:
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT01582711 History of Changes |
| Other Study ID Numbers: | CDC-NCHHSTP 6222, TBTC Study 33 |
| Study First Received: | February 10, 2012 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention:
|
LTBI LTB Latent TB TB infection |
Additional relevant MeSH terms:
|
Tuberculosis Latent Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Isoniazid Rifapentine Fatty Acid Synthesis Inhibitors Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents Antibiotics, Antitubercular Leprostatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013