Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis
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ClinicalTrials.gov Identifier: NCT00933790 |
Recruitment Status :
Completed
First Posted : July 7, 2009
Last Update Posted : April 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV Infection Pulmonary TB | Drug: ATT (Ethambutol, Pyrazinamide, INH, Rifampicin) | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 331 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Clinical Trial Comparing Daily Vs. Intermittent 6 - Month Short Course Chemotherapy in Reducing Failures & Emergence of Acquired Rifampicin Resistance (ARR) in Patients With HIV and Pulmonary Tuberculosis |
Actual Study Start Date : | September 14, 2009 |
Actual Primary Completion Date : | December 31, 2016 |
Actual Study Completion Date : | June 30, 2018 |

Arm | Intervention/treatment |
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Active Comparator: 2EHRZ3/4HR3
Regimen 3. Intermittent - 2EHRZ3/4HR3 (E 1200mg, H 600 mg, R 450/600 mg depending on Weight <60, 600 mg for 60 kg or more, Z 1500 mg given thrice weekly)
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Drug: ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)
Ethambutol 800 mg for daily, 1200 mg for intermittent therapy, Pyrazinamide 1500 mg for both daily and intermittent, INH 300 mg for daily and 600 mg for intermittent therapy, Rifampicin 450 mg for both daily and intermittent therapy for patients below 60 kg, 600 mg for both daily and intermittent therapy for patients 60 kg and above
Other Names:
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Experimental: 2EHRZ7/4HR7
Regimen 1. Daily - 2EHRZ7/4HR7 (E 800 mg ,H 300 mg, R 450/600 mg depending on Weight <60, 600 mg for 60 kg or more, Z 1500 mg daily)
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Drug: ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)
Ethambutol 800 mg for daily, 1200 mg for intermittent therapy, Pyrazinamide 1500 mg for both daily and intermittent, INH 300 mg for daily and 600 mg for intermittent therapy, Rifampicin 450 mg for both daily and intermittent therapy for patients below 60 kg, 600 mg for both daily and intermittent therapy for patients 60 kg and above
Other Names:
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Experimental: 2EHRZ7/4HR3
Regimen 2. Part Daily - 2EHRZ7/4HR3 (E 800 mg ,H 300 mg, R 450/600 mg depending on Weight <60, 600 mg for 60 kg or more, Z 1500 mg daily in the intensive phase followed by H-600 mg ,R-450/600 mg in the continuation phase thrice weekly)
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Drug: ATT (Ethambutol, Pyrazinamide, INH, Rifampicin)
Ethambutol 800 mg for daily, 1200 mg for intermittent therapy, Pyrazinamide 1500 mg for both daily and intermittent, INH 300 mg for daily and 600 mg for intermittent therapy, Rifampicin 450 mg for both daily and intermittent therapy for patients below 60 kg, 600 mg for both daily and intermittent therapy for patients 60 kg and above
Other Names:
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- unfavourable responses during treatment [ Time Frame: At the end of 6 months ]including bacteriological and failures and ARR, clinical failures, TEADRS requiring premanent discontinuation of the drug , Deaths except unnatural and Defaults during treatment period
- Unfavorable responses during follow-up [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ]recurrences and deaths during follow up
- TEADR's between the groups [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ]
- Incidence of Immune Reconstitution Syndrome among the groups [ Time Frame: At the end of 6 months and at the end of follow-up of 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age above 18 years.
- HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease.
- Initially smear negative but Xpert-MTB positive or LPA positive taken as a surrogate marker for culture positivity (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics). as BACTEC (Becton-Dickinson) has been phased out ,Final inclusion will only be patients positive by LJ culture
- Persistent X-ray abnormality will be included for allocation. However final inclusion into both ITT and efficacy analysis will depend on positivity in LJ culture.
- Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed.
- Likely to remain in the same area for at least one and half years after start of treatment.
- Willing for house visits and surprise checks.
- Willing to participate and give informed consent after going through the terms and conditions of the trial.
Exclusion Criteria:
- Patients with known hypersensitivity to rifampicin
- Pregnancy and lactation at initial presentation
- Major complications like HIV encephalopathy, renal dysfunction (serum creatinine > 1.5 mg% in the absence of dehydration) or jaundice (serum bilirubin > 2 mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal).
- Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment.
- Moribund, bedridden or unconscious patients.
- Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation.
- Major psychiatric illness.
- Patients on second line ART, mainly protease inhibitors, at initial presentation.

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 ClinicalTrials.gov identifier (NCT number): NCT00933790
India | |
Tuberculosis Research Centre (ICMR) | |
Chennai, Tamil Nadu, India, 600 031 | |
Govt. Hospital of Thoracic Medicine, Tambaram | |
Chennai, Tamil Nadu, India, 600 047 | |
Tuberculosis Research Centre (ICMR) | |
Madurai, Tamil Nadu, India, 625 020 |
Principal Investigator: | Narendran Gopalan, DNB (Chest) | Scientist 'B', Tuberculosis Research Centre (ICMR), Chennai, India | |
Principal Investigator: | Soumya Swaminathan, MD | Scientist 'F', Tuberculosis Research Centre (ICMR), Chennai, India |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Narendran Gopalan, Asst.Director, NIRT, Tuberculosis Research Centre, India |
ClinicalTrials.gov Identifier: | NCT00933790 |
Other Study ID Numbers: |
TRC25 |
First Posted: | July 7, 2009 Key Record Dates |
Last Update Posted: | April 10, 2019 |
Last Verified: | April 2019 |
TB HIV ARR Short course chemotherapy Drug resistance |
Tuberculosis Tuberculosis, Pulmonary Infections Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases Rifampin Pyrazinamide Ethambutol |
Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |