Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion
ConditionTuberculosis, Pulmonary
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Cape Town
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Atorvastatin 40mg
- Placebo oral tablet
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Cape Town
Lead sponsor
University of Zurich
Collaborator
University of Namibia
Collaborator
University of Bern
Collaborator
University of Stellenbosch
Collaborator
Source ClinicalTrials.gov