NCT03882177

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

Completed Phase 2 Results posted Last updated 18 September 2023

What this trial tests

Phase 2 trial testing Pravastatin in Tuberculosis in 16 participants. Completed in 31 December 2022.

Timeline

21 February 2020

Primary endpoint
12 May 2022

31 December 2022

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	21 February 2020
Primary completion	12 May 2022
Estimated completion	31 December 2022
Sites	1 location across South Africa

Drugs / interventions tested

• Pravastatin — full drug profile →
• Rifafour — full drug profile →
• Vitamin B6 — full drug profile →

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →
• Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Tuberculosis or Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Grade 3 or Higher Adverse Events Primary · Measured through Day 30

Graded using the DAIDS table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017

Group	Value	95% CI
Arm 1: Pravastatin (40 mg) and Rifafour	8
Arm 2: Pravastatin (80 mg) and Rifafour	4

Number of Participants Who Permanently Discontinue Assigned Study Regimen for Any Reason Secondary · Measured through Day 14

(Other than new recognition of participant ineligibility based on absence of M. tuberculosis growth in baseline sputum cultures, or growth of M. tuberculosis resistant to rifampin by GeneXpert)

Group	Value	95% CI
Arm 1: Pravastatin (40 mg) and Rifafour	10
Arm 2: Pravastatin (80 mg) and Rifafour	6
Arm 3: Pravastatin (120 mg) and Rifafour	0
Arm 4: Pravastatin (160 mg) and Rifafour	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Measured up to 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1: Pravastatin (40 mg) and Rifafour

Serious: 4/10 (40%)

Deaths: 0/10

Arm 2: Pravastatin (80 mg) and Rifafour

Serious: 1/6 (17%)

Deaths: 0/6

Arm 3: Pravastatin (120 mg) and Rifafour

Serious: 0

Deaths: 0

Arm 4: Pravastatin (160 mg) and Rifafour

Serious: 0

Deaths: 0

Serious adverse events (2 terms)

Reaction	System	Arm 1: Pravastatin (40 mg)…	Arm 2: Pravastatin (80 mg)…	Arm 3: Pravastatin (120 mg…	Arm 4: Pravastatin (160 mg…
Elevated Uric Acid	Investigations	—	—	—	—
Elevated liver enzymes (ALT/AST)	Investigations	—	—	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	Arm 1: Pravastatin (40 mg)…	Arm 2: Pravastatin (80 mg)…	Arm 3: Pravastatin (120 mg…	Arm 4: Pravastatin (160 mg…
Elevated uric acid	Investigations	—	—	—	—
Decreased hemoglobin level	Investigations	—	—	—	—
Elevated creatinine kinase	Investigations	—	—	—	—
Elevated liver enzymes (ALT/AST)	Investigations	—	—	—	—

Most-reported serious reactions: Elevated Uric Acid, Elevated liver enzymes (ALT/AST).

Data from ClinicalTrials.gov NCT03882177 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Host-directed immunotherapy of viral and bacterial infections: past, present and future.
   Wallis RS, O'Garra A, Sher A, Wack A. · · 2023 · cited 169× · PMID 35672482 · DOI 10.1038/s41577-022-00734-z
2. The Interplay Between Systemic Inflammation, Oxidative Stress, and Tissue Remodeling in Tuberculosis.
   Amaral EP, Vinhaes CL, Oliveira-de-Souza D, Nogueira B, et al · · 2021 · cited 54× · PMID 32559410 · DOI 10.1089/ars.2020.8124
3. Targeting Molecular Inflammatory Pathways in Granuloma as Host-Directed Therapies for Tuberculosis.
   Guler R, Ozturk M, Sabeel S, Motaung B, et al · · 2021 · cited 32× · PMID 34745105 · DOI 10.3389/fimmu.2021.733853
4. Potential Repurposed Drug Candidates for Tuberculosis Treatment: Progress and Update of Drugs Identified in Over a Decade.
   Sharma K, Ahmed F, Sharma T, Grover A, et al · · 2023 · cited 30× · PMID 37251185 · DOI 10.1021/acsomega.2c05511
5. Tuberculosis vaccines and therapeutic drug: challenges and future directions.
   An Y, Ni R, Zhuang L, Yang L, et al · · 2025 · cited 24× · PMID 39841361 · DOI 10.1186/s43556-024-00243-6
6. Host-directed therapies in pulmonary tuberculosis: Updates on anti-inflammatory drugs.
   Cubillos-Angulo JM, Nogueira BMF, Arriaga MB, Barreto-Duarte B, et al · · 2022 · cited 23× · PMID 36213651 · DOI 10.3389/fmed.2022.970408
7. Autophagy Induction as a Host-Directed Therapeutic Strategy against <i>Mycobacterium tuberculosis</i> Infection.
   Adikesavalu H, Gopalaswamy R, Kumar A, Ranganathan UD, et al · · 2021 · cited 18× · PMID 34070995 · DOI 10.3390/medicina57060522
8. Shedding Light on Autophagy During Human Tuberculosis. A Long Way to Go.
   Pellegrini JM, Tateosian NL, Morelli MP, García VE. · · 2021 · cited 13× · PMID 35071056 · DOI 10.3389/fcimb.2021.820095