Is NCT06632600 recruiting in Gainesville, FL?

Yes, NCT06632600 is currently recruiting participants at its Gainesville, FL location. This chagas disease clinical trial is actively enrolling qualified participants.

How do I join the chagas disease clinical trial in Gainesville?

To join this clinical trial in Gainesville, 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 Gainesville 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.

Chagas Disease Clinical Trial in Gainesville, FL

Who Can Participate

Inclusion Criteria

Male or female participants aged ≥ 18 years to ≤ 60 years old

Confirmed diagnosis of T. cruzi infection

History that participant has been determined to be in chronic phase of CD

Written informed consent must be obtained before any assessment is performed, and participants should express understanding of the consent form and the study

Participants must be considered by the investigator eligible for and able to comply with local prescribing information for benznidazole

Ability and willingness to communicate well with the investigator/study site and comply with requirements of the study

Exclusion Criteria

Signs (on physical examination) and/or symptoms of CD in the acute phase as determined by the investigator at screening

History of CD treatment with benznidazole or nifurtimox at any time in the past

History of and/or current (at screening) symptoms or signs (physical examination findings) of moderate or severe CD-related gastrointestinal disease

Participants who weigh \< 50 kg or \>90kg at screening

At sites conducting the MRI assessments, participants may participate in the overall study, but will be excluded from the MRI assessment if they have contraindications to MRI imaging

Any clinically significant disease during screening that, in the opinion of the investigator, would put the safety of the participant at risk through participating, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study, or would compromise participant compliance or preclude completion of the study

Documented history or current findings at screening of clinically significant cardiovascular conditions such as, but not limited to: unstable ischemic heart disease; NYHA Class III/IV heart failure (due to Chagas disease or other conditions); arrhythmias

Known or suspected ongoing, chronic or recurrent viral, bacterial or fungal infectious diseases including but not limited to: Tuberculosis, leishmaniasis, severe malaria, atypical mycobacterial infection, listeriosis, aspergillosis, or endemic mycoses, and/or documented positivity for human immunodeficiency virus (HIV) infection.

Participants with controlled HIV on antiretroviral therapy are eligible to participate if CD4 ≥ 500 at screening

History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years prior to screening (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)

Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the participant during the study period

Pancreatic injury or pancreatitis: If any single parameter of amylase or lipase exceeds 1.5x ULN at screening Participants with known recurrent pancreatitis (more than 1 episode in lifetime, from any cause) are excluded

Liver disease or liver injury as indicated by abnormal liver function tests (LFTs): Any single parameter of ALT, AST, alkaline phosphatase must not exceed 1.5x ULN at screening Serum bilirubin must not exceed the ULN at screening elevated serum bilirubin is not excluded if there is a documented history of Gilbert's Syndrome

History of renal disease as indicated by creatinine level above 1.5x ULN or microalbuminuria at screening; Evidence of urinary obstruction, or difficulty in voiding at screening; evidence of congenital renal abnormalities with known effect on renal function; calculated eGFR \<60 mL/min (\<0.835 mL/s) using the CKD-EPI formula for adults

Participants with screening hematology parameters outside of the thresholds

Current use of medications prohibited by the protocol at screening and/or baseline visits, or expected use of any prohibited medication during the study treatment period

Use of benznidazole in the blinded arms is prohibited until unblinding occurs after all participants complete Month 12.

Use of other investigational drugs at the time of study drug dosing

History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study or to benznidazole

History of drug abuse or unhealthy alcohol use within the 12 months prior to dosing

Pregnant or nursing (lactating/breast-feeding) women

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping of investigational drug and benznidazole

Participants who, in the opinion of the investigator, will not be able to comply with study procedures or visits, adhere to dosing schedule, or other otherwise be in compliance with study requirements Other protocol-defined inclusion/exclusion criteria may apply.

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 Gainesville?

Yes, this clinical trial (NCT06632600) has an active research site in Gainesville, FL 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.

Chagas Disease Treatment Options in Gainesville, FL

If you're searching for chagas disease treatment options in Gainesville, FL, this clinical trial (NCT06632600) 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 Gainesville research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced chagas disease 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 chagas disease clinical trials near you to find additional studies recruiting in your area.

Chagas Disease Clinical Trial in Gainesville, FL

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IRB Approved

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About This Chagas Disease Study in Gainesville