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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Safety of Administering Isoniazid to SLE Patients to Prevent TB

Study on the Safety of Administering Isoniazid to Systemic Lupus Erythematosus Patients to Prevent Tuberculosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 effectiveness of INH prophylaxis on the prevention of TB infection for SLE patients should be conducted, but before that, studies on the safety of INH therapy in SLE patients should be conducted.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: SLE patients with conditions of : - History of allergy to Isoniazid - Chronic liver disease, including chronic hepatitis B or C virus - Malignancy - Pregnancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Isoniazid/Pyridoxine

Treatment group received isoniazid 300mg and pyridoxine 10mg/day

DRUG

Saccharum Lactis

Control group received placebo

Locations (1)

Rumah Sakit Dr Hasan Sadikin, Universitas Padjadjaran
Bandung, West Java, Indonesia