Testing a new oral medication for treating pulmonary tuberculosis
A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis
This study is testing a new oral medication for people with newly diagnosed pulmonary tuberculosis to see if it helps reduce bacteria in the lungs when used with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 1 site (Cape Town) |
| Trial ID | NCT05382312 on ClinicalTrials.gov |
What this trial studies
This study evaluates the early bactericidal activity, safety, and tolerability of GSK3036656 when used in combination with either delamanid, bedaquiline, or standard care in adults with newly diagnosed rifampicin-susceptible pulmonary tuberculosis. Participants will receive the study treatment for 14 days before reverting to standard treatment. The study aims to gather data on the pharmacokinetics of the new medication and its effectiveness in reducing bacterial load in the lungs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with newly diagnosed, untreated rifampicin-susceptible pulmonary tuberculosis.
Not a fit: Patients with drug-resistant tuberculosis or those with significant comorbidities affecting treatment safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with pulmonary tuberculosis.
How similar studies have performed: Other studies have shown promise in using novel combinations of antitubercular agents, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants who have: 1. New episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB) 2. A chest X-ray picture consistent with pulmonary TB 3. At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/World Health Organization \[WHO\] scale) or positive on a molecular test (at least medium positive for MTB on Xpert MTB/Rif) 4. Normal echocardiogram or echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation is allowed and no valvular stenosis. 5. A creatinine clearance greater than or equal to (\>=)90 mL/minute (Cockroft-Gault formula). * Male participants are eligible to participate if they agree to barrier precautions until 90 days after last dose. * A female participant is eligible to participate if she is not pregnant or breast feeding and is a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) using a contraceptive method that is highly effective. A WOCBP must have a negative pregnancy test urine or serum as required by local regulations before the first dose of study intervention. Only participants who are at least 25 years of age (and females of non-childbearing potential) will be eligible for the positron emission tomography-computed tomography (PET-CT) assessments. * Capable of giving signed informed consent. Exclusion Criteria: * Evidence of a clinically significant (as judged by the Investigator) condition or abnormality (other than the indication being studied) that might compromise safety or the interpretation of trial efficacy or safety endpoints. * Clinically significant evidence of extrathoracic TB as judged by the Investigator. * QTc interval corrected for heart rate by Fridericia's formula (QTcF) greater than (\>)450 milliseconds (msec). * Arterial hypertension with Systolic BP \>=160 mm Hg or diastolic BP \>=100 nm Hg. Participants with well-controlled hypertension may be included if they are using amlodipine for the duration of the study. * Participants with vitiligo. * Participants receiving any QT prolonging drugs, including but not limited to fluoroquinolones, macrolides and clofazimine. * HIV infected participants: 1. having a cluster of differentiation (CD)4+ count \<350 cells/microliters; 2. having received any antiretroviral therapy medication within the last 30 days; 3. or having received oral or intravenous antifungal medication within the last 30 days; 4. or with an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection or malignancies in the last 12 months (except pulmonary TB). * Presence of Hepatitis B surface antigen (HBsAg) or Positive Hepatitis C antibody test result at screening. * Participants with diabetes (Type 1 or 2), point of care glycated hemoglobin (HbA1c) above 6.5%, or random glucose over 11.1 millimoles (mmol)/L * Any diseases or conditions in which use of delamanid or bedaquiline is contraindicated. * Participants with abnormal laboratory values at screening as graded by the enhanced Common Terminology Criteria for Adverse Events (CTCAE version 5 2017).
Where this trial is running
Cape Town
- GSK Investigational Site — Cape Town, South Africa (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.