Preventive Therapy for Tuberculosis in HIV Infected Persons
Recruitment status was Active, not recruiting
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Purpose
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 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 | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus Tuberculosis |
Drug: Isoniazid with Ethambutol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons |
- Primary outcome measure is the development of tuberculosis. [ Time Frame: September 2008 ] [ Designated as safety issue: No ]
- Secondary outcome measures include adverse drug reactions and mortality rate. [ Time Frame: September 2008 ] [ Designated as safety issue: Yes ]
| Enrollment: | 650 |
| Study Start Date: | February 2001 |
| Estimated Study Completion Date: | June 2011 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Isoniazid
Isoniazid (300mg) daily for 36 months
|
Drug: Isoniazid with Ethambutol
Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months
|
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:
- 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 both study groups will receive 10 mg of Pyridoxine daily during treatment.
Eligibility| Ages Eligible for Study: | 15 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Locations| India | |
| Tuberculosis Research Centre | |
| Chennai, Tamilnadu, India, 600 031 | |
| Principal Investigator: | Soumya Swaminathan, MD MNAMS | Tuberculosis Research Centre, India |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Soumya Swaminathan, Tuberculosis Research Centre, Indian Council of Medical Research |
| ClinicalTrials.gov Identifier: | NCT00351702 History of Changes |
| Other Study ID Numbers: | trc20B |
| Study First Received: | July 12, 2006 |
| Last Updated: | June 19, 2011 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Tuberculosis Research Centre, India:
|
Preventive therapy |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Ethambutol Isoniazid Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |
ClinicalTrials.gov processed this record on June 18, 2013