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Study identifier: NCT06618573 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Safety of Administering Isoniazid to SLE Patients to Prevent TB

Condition: Tuberculosis · Systemic Lupus Erythematosus  ·  Sponsor: Universitas Padjadjaran

PhasePhase 2/Phase 3
Planned participants60
Who can joinFemale, 18 Years to 55 Years
Healthy volunteersNo

About this study

Systemic Lupus Erythematosus (SLE) is a prototypical systemic autoimmune disease characterized by heterogeneity, multisystem involvement, and production of multiple autoantibodies. Clinical features can vary, from mild skin and joint involvement to severe and life-threatening conditions. Patients with lupus are more susceptible to infections, in addition to being immunocompromised, and due to the administration of corticosteroid and cytotoxic drugs. The presence of these infections is a cause of death in lupus disease in addition to the activity of the disease itself, especially in Asia-Pacific countries. One infection that often occurs in lupus is Tuberculosis (TB). Efforts have been made to prevent TB infection in vulnerable populations, including isoniazid (INH) prophylaxis. In 2010, World Heatlh Organization issued guidelines for HIV patients to receive INH prophylaxis to prevent TB infection. The implementation of Isoniazid Preventive Therapy (IPT) is quite cheap using INH with mild side effects.18 A meta-analysis study of INH prophylaxis in patients with HIV found that the efficacy of this prophylaxis significantly reduced TB incidence by 35% with an RR of 0.65%. In addition, INH was found to be safe, with no significant increase in drug reactions, according to a meta-analysis of prophylaxis studies in HIV patients. However, there is no guideline for INH prophylaxis for SLE patients, as there is for HIV patients, due to lack of data on this issue. Studies on the eff…

This description comes directly from the study's public registry record.

Talk to the study team

Laniyati Hamijoyo, MD, PhD  ·  +62222040151  ·  laniyati.hamijoyo@unpad.ac.id

Edhyana Sahiratmadja, MD, PhD  ·  +62222040151  ·  e.sahiratmadja@unpad.ac.id

Always discuss trial participation with your own doctor first.

Locations (1)

Rumah Sakit Dr Hasan Sadikin, Universitas PadjadjaranBandung, West Java, IndonesiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06618573