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Tests treatment safety and results for Latent Tuberculosis
Official title Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI
ClinicalTrials.gov ID: NCT03474029
What this study is testing
What is Rifapentine daily for 6 weeks?
Rifapentine daily for 6 weeks is an investigational medicine, given as an once-weekly, being studied as a potential treatment for latent tuberculosis.
Also referred to as priftin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 1. Persons with LTBI who do not have evidence of TB disease (see
You likely can't join if
- ) and are at increased risk of progression to TB. LTBI or M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test...
- Household and other close contacts (\> 4 hours of exposure in a one-week period) within 2 years prior to enrollment, of persons with...
- Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment...
- HIV co-infection (with CD4+ T-lymphocyte count \> 100 cells/mm3)
- ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.
- Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest...
See the full eligibility criteria
- 1. Persons with LTBI who do not have evidence of TB disease (see
- ) and are at increased risk of progression to TB. LTBI or M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g...
- Household and other close contacts (\> 4 hours of exposure in a one-week period) within 2 years prior to enrollment, of persons with bacteriologically confirmed TB. o Acceptable testing approaches for bacteriologic...
- Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who...
- HIV co-infection (with CD4+ T-lymphocyte count \> 100 cells/mm3)
- ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.
- Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB.
- Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB \> 150 per 100,000 (see Appendix D)...
- Recent (within 3 years prior to enrollment) immigration and seeking refugee/asylum status (see MOOP for additional details) to the United States or other country with low to moderate incidence from a country with an...
- Individuals with an increased risk of TB due to medical conditions such as end-stage renal disease.
- Individuals currently using immunosuppressive medications such as chronic steroids.
- Individuals with planned use of TNF-α inhibitors.
- Individuals with planned solid organ or hematologic transplantation
- Willing to provide signed informed consent, or parental permission and participant assent.
- For the following special populations, both inclusion criteria above must be met AND the criteria below depending on stage:
- Pregnant women in their second or third trimester (≥14 weeks gestation).
- Stage 1: Include only those who agree to participate in the semi-intensive PK component.
- Stage 2: Include regardless of semi-intensive PK component participation.
- Children aged less than 12 years
- Stage 1: Include only those who agree to participate in the semi-intensive PK component, based on enrollment strategy presented in Appendix I.
- Stage 2: Include regardless of semi-intensive PK component participation, based on PK findings and enrollment strategy described in Appendix I. Exclusion Criteria
- Failure to document positive IGRA or TST
- Current breastfeeding.
- Women who are currently pregnant in their first trimester (\<14 weeks gestation) or intend to become pregnant within 120 days of enrollment.
- Non-pregnant women of childbearing potential who refuse to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from activities that could lead to pregnancy.
- Current culture-positive TB, clinical TB, or suspected current TB. (Includes cases in which active TB cannot be excluded with reasonable clinical certainty by the site investigator. If sputum samples have been collected...
- TB resistant to any rifamycin in the source case
- A history of treatment for \> 7 consecutive days (if daily dosing) with a rifamycin or \>1 week (if weekly dosing) with a rifamycin and INH or \> 30 consecutive days with INH within 2 years prior to enrollment.
- A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative.
- History of allergy or intolerance to rifamycins.
- Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) \> 5x upper limit of normal among persons in whom screening ALT or AST is determined.
- Receiving concomitant medications that are known to be contraindicated with any study drug.
- Weight \< 25 kg for participants ≥ 12 years, and weight \< 3kg for participants \< 12 years
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Manhattan, New York, United States
- New York, New York, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Sydney, Australia
- Cotonou, Benin
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Port-au-Prince, Haiti
- Stellenbosch, South Africa
- Kampala, Uganda
- Ho Chi Minh City, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Manhattan, New York, United States; New York, New York, United States; San Antonio, Texas, United States; Seattle, Washington, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.