Preventive Therapy for Tuberculosis in HIV Infected Persons
Condition: Human Immunodeficiency Virus; Tuberculosis
MeSH terms: Tuberculosis; Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis
      in HIV infected persons

      Phase: Phase III trial

      Population: 650 HIV positive patients without tuberculosis

      Number of sites: Three

        1. Tuberculosis Research centre, Chennai

        2. Government General Hospital, Chennai

        3. Government Rajaji Hospital, Madurai

      Study Duration: 36 months

      Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing
      the incidence of tuberculosis and mortality among HIV-infected persons

      Study Design:

      The study will be a two-armed prospective randomized clinical trial among HIV- positive
      patients without active tuberculosis. Enrolled patients will be assigned to one of the two
      unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3
      years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be
      compared in each group.

      Study Endpoints:The primary end point of the study will be development of tuberculosis and
      the secondary endpoints will include adverse drug reactions and mortality rate.
    

Detailed description: 
      Study population and enrollment:

      All HIV positive patients seeking care at one of the study centers, above the age of 15
      years, not suffering from a serious illness, non-pregnant, and in whom TB was ruled out using
      the enhanced screening process, will be enrolled in the study. The consent form for
      prophylaxis trial will be read to the patients in the local language and written consent will
      be obtained from willing patients

      Randomization and Dosing:

      All patients enrolled in the prevention trial will be randomized to one of the study groups
      using a permuted block randomization scheme of four. Stratification will be done by Mantoux
      reading (>5mm and ≤5mm). The group assignment list will be generated centrally before the
      start of trial and sequentially numbered sealed envelopes containing the study group assigned
      will be prepared independently. At the initiation of prophylaxis, each patient will be
      counseled about the importance of taking drugs regularly. Patients will be asked to return
      the empty packets as well as unused tablets at each monthly visit.

      The treatment regimens in each study group will be as follows:

        1. Ethambutol (800 mg) and Isoniazid (300 mg) daily for six months, self-administered,
           collected once in fifteen days.

        2. Isoniazid (300 mg) daily for 3 years with fortnightly collection of drugs Subjects in
           both study groups will receive 10 mg of Pyridoxine daily during treatment.
    

Intervention name(s): Isoniazid with Ethambutol
Intervention type(s): Drug
Intervention description(s): Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
Intervention MeSH terms: Isoniazid; Ethambutol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preventive therapy