MedTrace Logo

StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis

NCT03882177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-09-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of pravastatin adjunctive therapy when combined with the standard tuberculosis (TB) treatment regimen in adults with TB.

Conditions

Interventions

DRUG

Pravastatin

Tablets, administered orally

DRUG

Rifafour

Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally

DIETARY_SUPPLEMENT

Vitamin B6

Administered orally.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Petros C. Karakousis, MD · Johns Hopkins University

  • Richard E. Chaisson, MD · Johns Hopkins University

  • Neil Martinson, MD, MPH · University of Witwatersrand, South Africa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-21
Primary Completion
2022-05-12
Completion
2022-12-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT03882177 on ClinicalTrials.gov