Safety of Administering Isoniazid to SLE Patients to Prevent TB

Launched by UNIVERSITAS PADJADJARAN · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called Isoniazid (INH) for patients with Systemic Lupus Erythematosus (SLE) to help prevent Tuberculosis (TB). People with lupus are more likely to get infections, including TB, because their immune systems are weaker. While there are guidelines for using Isoniazid to prevent TB in HIV patients, there aren't any for lupus patients, so this trial aims to gather important safety information first.

To participate in this study, individuals must be female SLE patients who do not currently show signs of active TB, are not undergoing treatment for TB, and have a stable health status without major infections or liver problems. Participants should expect to be monitored closely during the trial to ensure their safety while taking Isoniazid. If you or someone you know has lupus and meets these criteria, this trial could provide valuable insights into how to safely prevent TB in lupus patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• SLE patients with conditions of :
• • No signs and symptoms of active TB
• • Not under TB treatment
• • No History of TB, malignancy, HIV, liver function test abnormality
• • Not in pregnancy/lactation
• • No other active infections
• • Remission or low to moderate disease activity state
• • Consented to join the study completely
• Exclusion Criteria:
• SLE patients with conditions of :
• • History of allergy to Isoniazid
• • Chronic liver disease, including chronic hepatitis B or C virus
• • Malignancy
• • Pregnancy