RecruitingTuberculosis, Pulmonary
Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
Eligible age
18–65 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of Cape Town
You may qualify if…
- ✓ 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 24-week course of standard TB treatment (4RHZE/2RH)
- ✓ 5. Defined as "cured" by the TB Control Program of South Africa
- ✓ Laboratory parameters within 30 days before enrolment:
- ✓ 6. For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment
- ✓ 7. For HIV-infected participants: CD4 counts above 350 cells/µL within 30 days prior to enrolment
You may not qualify if…
- ✕ 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. Evidence of drug-resistant TB
- ✕ 6. Extrapulmonary TB, including pleural TB and/or large pleural effusion
- ✕ 7. Pregnant or desiring/trying to become pregnant in the next 6 months
- ✕ 8. Unable to take oral medications
Source: ClinicalTrials.gov · NCT04147286 · last updated 2024-08-23