Preventive Therapy for Tuberculosis in HIV Infected Persons

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Tuberculosis Research Centre, India.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
Tuberculosis Research Centre, India
ClinicalTrials.gov Identifier:
NCT00351702
First received: July 12, 2006
Last updated: June 19, 2011
Last verified: June 2011

July 12, 2006
June 19, 2011
February 2001
September 2008   (final data collection date for primary outcome measure)
Primary outcome measure is the development of tuberculosis. [ Time Frame: September 2008 ] [ Designated as safety issue: No ]
Primary outcome measure is the development of tuberculosis.
Complete list of historical versions of study NCT00351702 on ClinicalTrials.gov Archive Site
Secondary outcome measures include adverse drug reactions and mortality rate. [ Time Frame: September 2008 ] [ Designated as safety issue: Yes ]
Secondary outcome measures include adverse drug reactions and mortality rate.
Not Provided
Not Provided
 
Preventive Therapy for Tuberculosis in HIV Infected Persons
Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Human Immunodeficiency Virus
  • Tuberculosis
Drug: Isoniazid with Ethambutol
Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
Active Comparator: Isoniazid
Isoniazid (300mg) daily for 36 months
Intervention: Drug: Isoniazid with Ethambutol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
June 2011
September 2008   (final data collection date for primary outcome measure)

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 -
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00351702
trc20B
No
Dr. Soumya Swaminathan, Tuberculosis Research Centre, Indian Council of Medical Research
Tuberculosis Research Centre, India
United States Agency for International Development (USAID)
Principal Investigator: Soumya Swaminathan, MD MNAMS Tuberculosis Research Centre, India
Tuberculosis Research Centre, India
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP