Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atorvastatin 40mg

    Drug

    12 weeks of 40 mg atorvastatin therapy per os

  • Placebo oral tablet

    Drug

    Identical placebo

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Atorvastatin (Arm B)Active comparator 1 intervention
Group B: Placebo (Arm C)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total lung glycolysis (TLG) on PET/CT imaging

The primary outcome measure is total lung glycolysis (TLG) on PET/CT imaging. Total lung glycolysis (TLG), is the total glycolytic activity (TGA) in regions of interest (both lungs). Primary outcome measurement is semi-automated using nuclear medicine medical imaging software (MIM Software Inc.). Total lung masks are drawn on every participant's PET/CT scans. Glycolytic activity is derived for each lung (SUVbw\*mL), total lung glycolytic activity is the sum of both lungs TGA.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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