PACTR202211865409139RecruitingPhase 2
Preventing tuberculosis relapse and chronic lung disease: a proof-of-concept, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of atorvastatin to reduce inflammation after tuberculosis treatment completion in HIV-infected and HIV-uninfected adults measured by FDG-PET/CT
niversity of Cape Town0 sites342 target enrollmentStarted: November 22, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 342
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19 Year(s) to 44 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing
- •2. Age 18 to 65 years with body weight from 50 kg to 90 kg
- •3. Clinical response to TB treatment and sputum culture negative at week 16
- •4. Completed a course of standard TB treatment
- •Laboratory parameters within 30 days before enrolment:
- •5. For HIV-infected participants: suppressed HIV viral load within 30 days prior to enrolment
- •6. AST and ALT <3x upper limit of normal (ULN)
- •7. Creatinine <2x ULN
- •8. Hemoglobin >7.0 g/dL
- •9. Platelet count >50 x109 cells/L
- •10. Creatinine kinase <2x ULN
- •11. Able and willing to return to follow-up
- •12. Willing to have samples, including DNA, stored
- •13. Willing to consistently practice a highly reliable method of pregnancy prevention
Exclusion Criteria
- •1. Acute illness
- •2. Fever (temperature >38.0 degrees centigrade)
- •3. Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any lipid lowering agent in the near future.
- •4. Known allergy or contraindications to the investigational drug or any other statins
- •5. Any drug with significant drug-drug interaction that increase exposure to atorvastatin and potentially the risk for the participants (E.g. protease inhibitors)
- •6. Evidence of drug-resistant TB
- •7. Extrapulmonary TB, including pleural TB and/or large pleural effusion
- •8. Pregnant or desiring/trying to become pregnant in the next 6 months
- •9. Unable to take oral medications
- •10. Diabetes as defined by HbA1c=6.5, random glucose=200mg/dL (or 11.1mmol/L), fasting plasma glucose=126mg/dL (or 7.0mmol/L), or the presence of any anti-diabetic agent as a concomitant medicine
- •11. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
- •12. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
- •13. Use of any investigational drug in the previous 3 months
- •14. Alcohol and substance abuse which might interfere with medication adherence during the trial
- •15. Any person for whom the physician feels this study is not appropriate
- •16. Positive SARS-CoV-2 PCR or SARS-CoV-2 Rapid Antigen Test in the past 4 weeks
- •17. Claustrophobia - only for patients opting to undergo cardiac MRI
- •18. Pacemaker, bullet injury or ferromagnetic device or surgical clip (e.g. brain aneurysm clip, aortic clip, heart valve, insulin pump, IUD, joint replacement, protheses, wire sutures, dentures) - only for patients opting to undergo cardiac MRI
- •19. Allergy to CMR contrast media - only for patients opting to undergo cardiac MR
Investigators
Similar Trials
Not yet recruiting
Not Applicable
Inactive tuberculosis and its association with blood sugar levels among health care workersCTRI/2022/10/046325JIPMER
Unknown
Not Applicable
Prednisone with early ART in HIV-TBHIV/AIDSTuberculosisPACTR201304000511413niversity of Cape Town240
Active, not recruiting
Not Applicable
Preventive therapy for multidrug-resistant tuberculosis: a multicentre clincal trial. - MOXEPEUCTR2008-006765-82-ITISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Completed
Not Applicable
Impact of GneXpert MTB/RIF on TB outcomes in an ART clinicHIV/AIDSTuberculosisPACTR201303000505764Professor Peter Mason400
Recruiting
Not Applicable
Prevention of early mortality by presumptive TB treatment [retrospectively registered]HIV/AIDSTuberculosisPACTR201110000301425Academic Medical Center, University of Amsterdam334