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New treatment option for Tuberculosis, Pulmonary
Official title Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
ClinicalTrials.gov ID: NCT04147286
What this study is testing
What is Atorvastatin 40mg?
Atorvastatin 40mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for tuberculosis, pulmonary.
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 is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in HIV-infected and HIV-uninfected adults measured by PET/CT.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing
- Age 18 to 65 years with body weight from 50 kg to 90 kg
- Clinical response to TB treatment and sputum culture negative at week 16
- Completed a 24-week course of standard TB treatment (4RHZE/2RH)
- Defined as "cured" by the TB Control Program of South Africa Laboratory parameters within 30 days before enrolment:
You likely can't join if
- Acute illness
- Fever (temperature \>38.0 degrees centigrade)
- Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any...
- Known allergy or contraindications to the investigational drug or any other statins
- Evidence of drug-resistant TB
- Extrapulmonary TB, including pleural TB and/or large pleural effusion
See the full eligibility criteria
- Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing
- Age 18 to 65 years with body weight from 50 kg to 90 kg
- Clinical response to TB treatment and sputum culture negative at week 16
- Completed a 24-week course of standard TB treatment (4RHZE/2RH)
- Defined as "cured" by the TB Control Program of South Africa Laboratory parameters within 30 days before enrolment:
- For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment
- For HIV-infected participants: CD4 counts above 350 cells/µL within 30 days prior to enrolment
- AST and ALT \<3x upper limit of normal (ULN)
- Creatinine \<2x ULN
- Hemoglobin \>7.0 g/dL
- Platelet count \>50 x109 cells/L
- Creatinine kinase \<2x ULN
- Able and willing to return to follow-up
- Willing to have samples, including DNA, stored
- Willing to consistently practice a highly reliable method of pregnancy prevention
- Acute illness
- Fever (temperature \>38.0 degrees centigrade)
- 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.
- Known allergy or contraindications to the investigational drug or any other statins
- Evidence of drug-resistant TB
- Extrapulmonary TB, including pleural TB and/or large pleural effusion
- Pregnant or desiring/trying to become pregnant in the next 6 months
- Unable to take oral medications
- Diabetes as defined by point of care 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 (including traditional medicines) as a...
- 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...
- Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
- Use of any investigational drug in the previous 3 months
- Alcohol and substance abuse which might interfere with medication adherence during the trial
- Any person for whom the physician feels this study is not appropriate
The study team makes the final eligibility decision.
Where it's taking place
- Observatory, WC, South Africa
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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Observatory, WC, South Africa. 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.