Preventive Therapy for Tuberculosis in HIV Infected Persons
Tuberculosis Research Centre, India
United States Agency for International Development (USAID)
Information provided by (Responsible Party)
Dr Soumya Swaminathan, Tuberculosis Research Centre, India
First received: July 12, 2006
Last updated: June 6, 2016
Last Verified: June 2016
History of Changes
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
- Tuberculosis Research centre, Chennai
- Government General Hospital, Chennai
- Government Rajaji Hospital, Madurai
Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons
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.
Human Immunodeficiency Virus
Drug : Isoniazid with Ethambutol
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|
Further study details as provided by Dr Soumya Swaminathan, Tuberculosis Research Centre, India:
Primary Outcome Measures
- Primary outcome measure is the development of tuberculosis. [ Time Frame: September 2008 ]
- Secondary outcome measures include adverse drug reactions and mortality rate. [ Time Frame: September 2008 ]
|Study Start Date:||February 2001|
|Study Completion Date:||June 2011|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Isoniazid (300mg) daily for 36 months
Isoniazid with Ethambutol
Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
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:
- Ethambutol (800 mg) and Isoniazid (300 mg) daily for six months, self-administered, collected once in fifteen days.
- Isoniazid (300 mg) daily for 3 years with fortnightly collection of drugs Subjects in
|Ages Eligible for Study:||15 Years to 60 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age > 15 years
- HIV positivity (on 2 different ELISA tests on the same blood sample)
- Living in Chennai or Madurai within a defined area of intake - 25 km radius.
- Likely to remain in the same area for at least three years after start of treatment
- The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
- Is agreeable for home visits
- No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
- No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
- 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.
- Resides outside area of intake.
- Pregnancy and lactation.
- Patients with major psychiatric illnesses and severe depression
- Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
- Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
- Previous antituberculosis treatment for more than 1 month
- Patients on ART -
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351702
Locations Show More
|Tuberculosis Research Centre|
|Chennai, Tamilnadu, India, 600 031|
Sponsors and CollaboratorsTuberculosis Research Centre, India
United States Agency for International Development (USAID)
|Principal Investigator:||Soumya Swaminathan, MD MNAMS||Tuberculosis Research Centre, India|
Additional Information:Indian Council of Medical Research
|Responsible Party:||Dr Soumya Swaminathan, Director, Tuberculosis Research Centre, India|
|ClinicalTrials.gov Identifier:||NCT00351702 History of Changes|
|Other Study ID Numbers:||trc20B|
|Study First Received:||July 12, 2006|
|Last Updated:||June 6, 2016|
Keywords provided by Dr Soumya Swaminathan, Tuberculosis Research Centre, India:Preventive therapy
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on April 19, 2018
This information is provided by ClinicalTrials.gov.