Preventive Therapy for Tuberculosis in HIV Infected Persons

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351702
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : June 7, 2016
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Dr Soumya Swaminathan, Tuberculosis Research Centre, India

Brief 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Tuberculosis Drug: Isoniazid with Ethambutol Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons
Study Start Date : February 2001
Actual Primary Completion Date : September 2008
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Isoniazid
Isoniazid (300mg) daily for 36 months
Drug: Isoniazid with Ethambutol
Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months

Primary Outcome Measures :
  1. Primary outcome measure is the development of tuberculosis. [ Time Frame: September 2008 ]

Secondary Outcome Measures :
  1. Secondary outcome measures include adverse drug reactions and mortality rate. [ Time Frame: September 2008 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 15 years
  2. HIV positivity (on 2 different ELISA tests on the same blood sample)
  3. Living in Chennai or Madurai within a defined area of intake - 25 km radius.
  4. Likely to remain in the same area for at least three years after start of treatment
  5. The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
  6. Is agreeable for home visits
  7. No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
  8. No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
  9. Patients who fulfill laboratory criteria (hemoglobin > 7.0g/l,granulocyte count>11,000/l, platelet count > 1 lakh/l. serum alanine amino transferase concentration < 2.5 times the upper limit of normal and serum creatinine concentration < 1.1 mgs%, random blood sugar < 140 mgs%) will be enrolled into the study.

Exclusion Criteria:

  1. Resides outside area of intake.
  2. Pregnancy and lactation.
  3. Patients with major psychiatric illnesses and severe depression
  4. Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
  5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
  6. Previous antituberculosis treatment for more than 1 month
  7. Patients on ART -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351702

Tuberculosis Research Centre
Chennai, Tamilnadu, India, 600 031
Sponsors and Collaborators
Tuberculosis Research Centre, India
United States Agency for International Development (USAID)
Principal Investigator: Soumya Swaminathan, MD MNAMS Tuberculosis Research Centre, India

Additional Information:
Study Data/Documents: published manuscript  This link exits the site
the study has been published and has been provided in the citation. the paper conatins the required information regarding study results and conclusion

Publications of Results:
Other Publications:

Responsible Party: Dr Soumya Swaminathan, Director, Tuberculosis Research Centre, India Identifier: NCT00351702     History of Changes
Other Study ID Numbers: trc20B
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016

Keywords provided by Dr Soumya Swaminathan, Tuberculosis Research Centre, India:
Preventive therapy

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents