Safety of Administering Isoniazid to SLE Patients to Prevent TB

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorUniversitas Padjadjaran

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of allergy to Isoniazid

Chronic liver disease, including chronic hepatitis B or C virus

Malignancy

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Isoniazid/Pyridoxine

    Drug

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

  • Saccharum Lactis

    Drug

    Control group received placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment GroupActive comparator 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Drug Induce Hepatitis

Change in more than twice the upper limit of normal SGOT/SGPT values and improvement after drug discontinuation

Time frame
week 2, months 1, 2, 3, 6, 9, 12
2

SLE disease activity

Based on Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score. The higher the score, the worse. SLEDAI score increase in more than 3=flare

Time frame
month 1, 2, 3, 6, 9, 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.