Is NCT03474029 recruiting in Denver, CO?

Yes, NCT03474029 is currently recruiting participants at its Denver, CO location. This latent tuberculosis clinical trial is actively enrolling qualified participants.

How do I join the latent tuberculosis clinical trial in Denver?

To join this clinical trial in Denver, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Denver clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Latent Tuberculosis Clinical Trial in Denver, CO

About This Latent Tuberculosis Study in Denver

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). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have t

Sponsor: Centers for Disease Control and Prevention

Who Can Participate

Inclusion Criteria

Persons with LTBI who do not have evidence of TB disease (see

Exclusion Criteria

) 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., QuantiFERON or T.SPOT.TB). Details of testing definitions and requirements for each risk factor are further described in the MOOP. Persons with LTBI at increased risk of progression to TB are those with at least one of the following:

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 confirmation are 1) culture with rifamycin DST; or, 2) nucleic acid amplification tests (NAATs) that detect M. tuberculosis and detect mutations associated with rifamycin resistance. Additional details on bacteriologic confirmation, including accepted NAATs, will be included in the MOOP.

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 have a conversion by IGRA may require additional evaluation to rule out a false conversion. Additional guidance and definitions of conversion are in the MOOP.

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) and either a positive IGRA or a TST ≥15 mm (TST \> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).

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 estimated incidence rate of TB \> 75 per 100,000 (see Appendix E) and either a positive IGRA or a TST ≥15 mm (TST \> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).

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 AND site investigators have suspicion of active TB, site investigators must wait to review culture results prior to enrollment.)

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Denver?

Yes, this clinical trial (NCT03474029) has an active research site in Denver, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Latent Tuberculosis Treatment Options in Denver, CO

If you're searching for latent tuberculosis treatment options in Denver, CO, this clinical trial (NCT03474029) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Denver research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced latent tuberculosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all latent tuberculosis clinical trials near you to find additional studies recruiting in your area.

Latent Tuberculosis Clinical Trial in Denver, CO

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