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Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion

NCT04147286 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2024-08-23

No results posted yet for this study

Summary

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.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

Atorvastatin 40mg

12 weeks of 40 mg atorvastatin therapy per os

DRUG

Placebo oral tablet

Identical placebo

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • University of Namibia

    collaborator OTHER

  • University of Bern

    collaborator OTHER

  • University of Stellenbosch

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Friedrich Thienemann, MD · University of Cape Town

  • Reto Guler, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-14
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147286 on ClinicalTrials.gov