TuberculosisPhase 3NCT00376012
Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
A Phase 3 study testing Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) in people with Tuberculosis and Human Immunodeficiency Virus Infections, run by Tuberculosis Research Centre, India at 1 site in India.
Trial summary
Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis Phase: Phase III trial Population: 300 HIV positive patients with tuberculosis. Number of Sites:Four 1. Tuberculosis Research Centre, Chennai 2. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Tuberculosis, Human Immunodeficiency Virus Infections
- What is being tested?
- Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2001to Sep 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 thrice-weekly attendance for the first 2/3 months and once-weekly thereafter for the next 4 to 7 months
- Is agreeable for home visits
Show all 9Show fewer
- 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 =>70 g/L, granulocyte count >1.1 X 109/L, platelet count > 100X 109/L, serum alanine amino transferase concentration <2.5 times the upper limit of normal, serum creatinine concentration <1.1mg%, random blood sugar < 140 mg/dl) will be enrolled in to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Assess the Efficacy of Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis
Phase: Phase III trial
Read more
Population: 300 HIV positive patients with tuberculosis.
Number of Sites:Four
- Tuberculosis Research Centre, Chennai
- Government General Hospital, Chennai
- Government Hospital of Thoracic Medicine, Tambaram
- Government Rajaji Hospital, Madurai
Study Duration:36 months
Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 / 4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the treatment of pulmonary and extrapulmonary TB in the HIV positive patients.
- To study the relationship between stage of HIV disease and response to anti-TB treatment.
- To study recurrences and their nature (relapse/re-infection) in detail by using RFLP analysis.
Study Design:It is a two armed prospective randomized open label controlled clinical trial with stratified random allocation based on CD4 count and sputum smear grade.
All enrolled patients will be treated according to the RNTCP guidelines during the intensive phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by smear grade, and randomly allocated either to the standard RNTCP regimen, or to an alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).
Read the detailed description
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 diagnosed with TB will be briefly explained the treatment trial.Patients willing to participate in the trial will be asked to provide written consent. Patients who refuse participation in the study will be managed according to the RNTCP guidelines.
All patients who provide written consent to participate in the treatment trial will be interviewed by a social worker using a standard questionnaire. Patients on anti-retroviral drugs will be excluded from the study. Blood samples will be collected from patients meeting initial eligibility criteria to test for laboratory eligibility criteria. Laboratory investigations will include complete heamogram,Renal function tests, Liver function tests, random blood sugar, urine albumin and urine sugar. Patients who fulfill laboratory criteria (hemoglobin >70 g/L, granulocyte count >1.1 X 109/L, platelet count > 100X 109/L, serum alanine amino transferase concentration <2.5 times the upper limit of normal, serum creatinine concentration <1.1mg%, random blood sugar < 140 mg/dl) will be enrolled in to the study.
Randomization and Dosing:
All patients enrolled into the treatment trial will receive supervised directly observed treatment during the intensive phase. At treatment initiation, each patient will be counseled about the importance of treatment regularity. While patients are undergoing intensive phase treatment, they will be randomized either to the standard regimen or to the extended regimen as soon as CD4 results are available. Randomization will be done according to a permuted block scheme in blocks of four, stratified by CD4 counts (> 200 and ≤200) and by smear grade (0, 1+, 2+, or 3+). The treatment assignment list will be generated before the start of trial and sequentially numbered sealed envelopes containing the treatment assigned will be prepared independently.
The treatment regimens in each arm of the trial will be as follows:
Category I RNTCP regimen 2EHRZ3/4RH3 Trial regimen 2EHRZ3/7RH3 Category II RNTCP regimen 2SEHRZ3/1EHRZ3/5EHR3 Category III RNTCP regimen 2HRZ3/4RH3. All anti-TB drugs will be administered as per the RNTCP strategy of DOTS. Patients residing in Chennai and Madurai will attend the respective centers/ sub-centers three times a week for the intensive phase of treatment (first two/three months) and then once a week during the continuation phase (four to seven months). Dosages will be as per RNTCP manual and may be modified if the patient is extremely debilitated (weight < 30 kg). Patients in all treatment arms will receive 10 mg of Pyridoxine on treatment days and Co-trimoxazole DS 1 tablet daily.
During chemotherapy, patients will be called to the clinic for monthly clinical evaluation. During follow-up visits at the clinic (monthly up to 24 months, every 3 months after that), patients will be thoroughly evaluated for likely drug toxicity and the information on adverse effects will be recorded on a standardized toxicity chart.
Compliance with therapy will be measured by checking treatment cards, DOTS provider notebooks and empty drug packets. Additionally, spot urine examination will be performed to check for acetyl isoniazid and rifampicin levels at each monthly.
Statistical analysis:
The intention-to-treat approach will be used for analyzing the data for primary and secondary end points. Annual interim analyses will be done to ensure timely identification of any significant risks or benefits to patients.
Comparisons of categorical variables will be done by chi-square test and Fisher's exact test. Continuous variables will be compared by t test or by Wilcoxon's rank sum test. Survival estimates will be made by the Kaplan-Meier method. Comparison of Kaplan-Meier survival curves will be made with the log-rank test. Multivariate analyses will be performed using Cox's proportional Hazards model.
- Being tested
- Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)
- Keywords
- Chemotherapy for TB in HIV infection
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)Drug
Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months.
Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)Drug
Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 7 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 2EHRZ3/4RH3 Receives: Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) |
| 2 | Experimental | 2EHRZ3/7RH3 Receives: Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures are TB cure and relapse rates
Measured: 2 years
Secondary outcomes (1)
Secondary Outcome measure is mortality rates.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startFeb 2001
- Primary completionSep 2007 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Research Centre, India
- Sponsor type
- Other government
- Investigators
- Soumya Swaminathan, MD MNAMS, Principal investigator, Tuberculosis Research Centre, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376012
- Sponsor's protocol ID
- trc20A
- Status last verified
- May 2008
- First submitted
- 13 Sep 2006
- Last updated
- 11 Jun 2008
- Results posted
- No
Publications
Chaisson RE, Clermont HC, Holt EA, Cantave M, Johnson MP, Atkinson J, Davis H, Boulos R, Quinn TC, Halsey NA. Six-month supervised intermittent tuberculosis therapy in Haitian patients with and without HIV infection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1034-8. doi: 10.1164/ajrccm.154.4.8887603.
PubMed 8887603El-Sadr WM, Perlman DC, Denning E, Matts JP, Cohn DL. A review of efficacy studies of 6-month short-course therapy for tuberculosis among patients infected with human immunodeficiency virus: differences in study outcomes. Clin Infect Dis. 2001 Feb 15;32(4):623-32. doi: 10.1086/318706. Epub 2001 Feb 9.
PubMed 11181127Perriens JH, St Louis ME, Mukadi YB, Brown C, Prignot J, Pouthier F, Portaels F, Willame JC, Mandala JK, Kaboto M, et al. Pulmonary tuberculosis in HIV-infected patients in Zaire. A controlled trial of treatment for either 6 or 12 months. N Engl J Med. 1995 Mar 23;332(12):779-84. doi: 10.1056/NEJM199503233321204.
PubMed 7862181Kassim S, Sassan-Morokro M, Ackah A, Abouya LY, Digbeu H, Yesso G, Coulibaly IM, Coulibaly D, Whitaker PJ, Doorly R, et al. Two-year follow-up of persons with HIV-1- and HIV-2-associated pulmonary tuberculosis treated with short-course chemotherapy in West Africa. AIDS. 1995 Oct;9(10):1185-91. doi: 10.1097/00002030-199510000-00011.
PubMed 8519456Alwood K, Keruly J, Moore-Rice K, Stanton DL, Chaulk CP, Chaisson RE. Effectiveness of supervised, intermittent therapy for tuberculosis in HIV-infected patients. AIDS. 1994 Aug;8(8):1103-8. doi: 10.1097/00002030-199408000-00010.
PubMed 7986406el-Sadr WM, Perlman DC, Matts JP, Nelson ET, Cohn DL, Salomon N, Olibrice M, Medard F, Chirgwin KD, Mildvan D, Jones BE, Telzak EE, Klein O, Heifets L, Hafner R. Evaluation of an intensive intermittent-induction regimen and duration of short-course treatment for human immunodeficiency virus-related pulmonary tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG). Clin Infect Dis. 1998 May;26(5):1148-58. doi: 10.1086/520275.
PubMed 9597244Swaminathan S, Narendran G, Venkatesan P, Iliayas S, Santhanakrishnan R, Menon PA, Padmapriyadarsini C, Ramachandran R, Chinnaiyan P, Suhadev M, Sakthivel R, Narayanan PR. Efficacy of a 6-month versus 9-month intermittent treatment regimen in HIV-infected patients with tuberculosis: a randomized clinical trial. Am J Respir Crit Care Med. 2010 Apr 1;181(7):743-51. doi: 10.1164/rccm.200903-0439OC. Epub 2009 Dec 3.
PubMed 19965813
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess the Efficacy of Short Course Intermittent Regimens for the Treatment of HIV-Associated Tuberculosis
- ClinicalTrials.gov ID
- NCT00376012
- Acronym / sponsor ID
- trc20A
- Keywords
- Chemotherapy for TB in HIV infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tuberculosis Research Centre, IndiaOther government
- Study start
- Feb 2001
- Primary completion
- Sep 2007 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 14 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Randomized clinical trial to assess the efficacy of short course intermittent regimens for the treatment of HIV-associated tuberculosis
Phase: Phase III trial
Population: 300 HIV positive patients with tuberculosis.
Number of Sites:Four
- Tuberculosis Research Centre, Chennai
- Government General Hospital, Chennai
- Government Hospital of Thoracic Medicine, Tambaram
- Government Rajaji Hospital, Madurai
Study Duration:36 months
Study Objective:To study the efficacy of the standard RNTCP Category I regimen (2EHRZ3 / 4RH3) the control arm vs. an extended continuation phase regimen 2EHRZ3 / 7 RH3 in the treatment of pulmonary and extrapulmonary TB in the HIV positive patients.
- To study the relationship between stage of HIV disease and response to anti-TB treatment.
- To study recurrences and their nature (relapse/re-infection) in detail by using RFLP analysis.
Study Design:It is a two armed prospective randomized open label controlled clinical trial with stratified random allocation based on CD4 count and sputum smear grade.
All enrolled patients will be treated according to the RNTCP guidelines during the intensive phase. In the continuation phase, Cat I patients will be stratified by CD4 counts and by smear grade, and randomly allocated either to the standard RNTCP regimen, or to an alternative extended regimen (2EHRZ3/4RH3 or 2EHRZ3/7RH3).
Detailed description
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 diagnosed with TB will be briefly explained the treatment trial.Patients willing to participate in the trial will be asked to provide written consent. Patients who refuse participation in the study will be managed according to the RNTCP guidelines.
All patients who provide written consent to participate in the treatment trial will be interviewed by a social worker using a standard questionnaire. Patients on anti-retroviral drugs will be excluded from the study. Blood samples will be collected from patients meeting initial eligibility criteria to test for laboratory eligibility criteria. Laboratory investigations will include complete heamogram,Renal function tests, Liver function tests, random blood sugar, urine albumin and urine sugar. Patients who fulfill laboratory criteria (hemoglobin >70 g/L, granulocyte count >1.1 X 109/L, platelet count > 100X 109/L, serum alanine amino transferase concentration <2.5 times the upper limit of normal, serum creatinine concentration <1.1mg%, random blood sugar < 140 mg/dl) will be enrolled in to the study.
Randomization and Dosing:
All patients enrolled into the treatment trial will receive supervised directly observed treatment during the intensive phase. At treatment initiation, each patient will be counseled about the importance of treatment regularity. While patients are undergoing intensive phase treatment, they will be randomized either to the standard regimen or to the extended regimen as soon as CD4 results are available. Randomization will be done according to a permuted block scheme in blocks of four, stratified by CD4 counts (> 200 and ≤200) and by smear grade (0, 1+, 2+, or 3+). The treatment assignment list will be generated before the start of trial and sequentially numbered sealed envelopes containing the treatment assigned will be prepared independently.
The treatment regimens in each arm of the trial will be as follows:
Category I RNTCP regimen 2EHRZ3/4RH3 Trial regimen 2EHRZ3/7RH3 Category II RNTCP regimen 2SEHRZ3/1EHRZ3/5EHR3 Category III RNTCP regimen 2HRZ3/4RH3. All anti-TB drugs will be administered as per the RNTCP strategy of DOTS. Patients residing in Chennai and Madurai will attend the respective centers/ sub-centers three times a week for the intensive phase of treatment (first two/three months) and then once a week during the continuation phase (four to seven months). Dosages will be as per RNTCP manual and may be modified if the patient is extremely debilitated (weight < 30 kg). Patients in all treatment arms will receive 10 mg of Pyridoxine on treatment days and Co-trimoxazole DS 1 tablet daily.
During chemotherapy, patients will be called to the clinic for monthly clinical evaluation. During follow-up visits at the clinic (monthly up to 24 months, every 3 months after that), patients will be thoroughly evaluated for likely drug toxicity and the information on adverse effects will be recorded on a standardized toxicity chart.
Compliance with therapy will be measured by checking treatment cards, DOTS provider notebooks and empty drug packets. Additionally, spot urine examination will be performed to check for acetyl isoniazid and rifampicin levels at each monthly.
Statistical analysis:
The intention-to-treat approach will be used for analyzing the data for primary and secondary end points. Annual interim analyses will be done to ensure timely identification of any significant risks or benefits to patients.
Comparisons of categorical variables will be done by chi-square test and Fisher's exact test. Continuous variables will be compared by t test or by Wilcoxon's rank sum test. Survival estimates will be made by the Kaplan-Meier method. Comparison of Kaplan-Meier survival curves will be made with the log-rank test. Multivariate analyses will be performed using Cox's proportional Hazards model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)2EHRZ3/4RH3 |
| 2 | Experimental | Drug: Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)2EHRZ3/7RH3 |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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 thrice-weekly attendance for the first 2/3 months and once-weekly thereafter for the next 4 to 7 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 4 months. | Drug | 1 |
| Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide)Arm 1 is a standard six-month intermittent regimen consisting of Ethambutol, Isoniazid, Rifampicin and Pyrazinamide given thrice weekly for 2 months followed by Rifampicin and Isoniazid given thrice-weekly for 7 months. | Drug | 2 |
Primary outcome
Primary outcome measures are TB cure and relapse rates
Time frame: 2 years
1 secondary outcome
Secondary Outcome measure is mortality rates.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
- Background: PubMed 8887603Chaisson RE, Clermont HC, Holt EA, Cantave M, Johnson MP, Atkinson J, Davis H, Boulos R, Quinn TC, Halsey NA. Six-month supervised intermittent tuberculosis therapy in Haitian patients with and without HIV infection. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1034-8. doi: 10.1164/ajrccm.154.4.8887603.
- Background: PubMed 11181127El-Sadr WM, Perlman DC, Denning E, Matts JP, Cohn DL. A review of efficacy studies of 6-month short-course therapy for tuberculosis among patients infected with human immunodeficiency virus: differences in study outcomes. Clin Infect Dis. 2001 Feb 15;32(4):623-32. doi: 10.1086/318706. Epub 2001 Feb 9.
- Background: PubMed 7862181Perriens JH, St Louis ME, Mukadi YB, Brown C, Prignot J, Pouthier F, Portaels F, Willame JC, Mandala JK, Kaboto M, et al. Pulmonary tuberculosis in HIV-infected patients in Zaire. A controlled trial of treatment for either 6 or 12 months. N Engl J Med. 1995 Mar 23;332(12):779-84. doi: 10.1056/NEJM199503233321204.
- Background: PubMed 8519456Kassim S, Sassan-Morokro M, Ackah A, Abouya LY, Digbeu H, Yesso G, Coulibaly IM, Coulibaly D, Whitaker PJ, Doorly R, et al. Two-year follow-up of persons with HIV-1- and HIV-2-associated pulmonary tuberculosis treated with short-course chemotherapy in West Africa. AIDS. 1995 Oct;9(10):1185-91. doi: 10.1097/00002030-199510000-00011.
- Background: PubMed 7986406Alwood K, Keruly J, Moore-Rice K, Stanton DL, Chaulk CP, Chaisson RE. Effectiveness of supervised, intermittent therapy for tuberculosis in HIV-infected patients. AIDS. 1994 Aug;8(8):1103-8. doi: 10.1097/00002030-199408000-00010.
- Background: PubMed 9597244el-Sadr WM, Perlman DC, Matts JP, Nelson ET, Cohn DL, Salomon N, Olibrice M, Medard F, Chirgwin KD, Mildvan D, Jones BE, Telzak EE, Klein O, Heifets L, Hafner R. Evaluation of an intensive intermittent-induction regimen and duration of short-course treatment for human immunodeficiency virus-related pulmonary tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA) and the AIDS Clinical Trials Group (ACTG). Clin Infect Dis. 1998 May;26(5):1148-58. doi: 10.1086/520275.
- Derived from this study: PubMed 19965813Swaminathan S, Narendran G, Venkatesan P, Iliayas S, Santhanakrishnan R, Menon PA, Padmapriyadarsini C, Ramachandran R, Chinnaiyan P, Suhadev M, Sakthivel R, Narayanan PR. Efficacy of a 6-month versus 9-month intermittent treatment regimen in HIV-infected patients with tuberculosis: a randomized clinical trial. Am J Respir Crit Care Med. 2010 Apr 1;181(7):743-51. doi: 10.1164/rccm.200903-0439OC. Epub 2009 Dec 3.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soumya Swaminathan, MD MNAMS principal investigator
Tuberculosis Research Centre, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-TB drugs (Ethambutol, Isoniazid, Rifampicin and Pyrazinamide) in people with Tuberculosis and Human Immunodeficiency Virus Infections, run by Tuberculosis Research Centre, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measures are TB cure and relapse rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00376012, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2008.