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Tuberculosis Treatment Shortening Trial

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ClinicalTrials.gov Identifier: NCT00130247
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : January 27, 2010
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tuberculosis
Interventions Drug: Ethambutol
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Rifampin
Enrollment 394
Recruitment Details HIV-uninfected 18 to 60 year old adults with suspected or newly diagnosed pulmonary tuberculosis were eligible for enrollment at participating sites in Kampala, Uganda; Vitória, Brazil; and Manila/Makati City, the Philippines. Screening began in April 2002 in Uganda, December 2002 in Brazil, and November 2003 in the Philippines.
Pre-assignment Details Subjects who met eligibility criteria were started on standard chemotherapy and routinely followed during anti-TB therapy. Patients with drug-susceptible TB who were sputum culture negative after 2 months of treatment were randomly assigned at 4 months to stop treatment or received an additional 2 months of daily isoniazid (INH) and rifampicin.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks. Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Period Title: Overall Study
Started 196 198
Completed 194 194
Not Completed 2 4
Reason Not Completed
Pregnancy             1             0
Post-randomization exclusion             1             2
Not compliant with DOT             0             2
Arm/Group Title 4-Month Arm 6-Month Arm Total
Hide Arm/Group Description Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks. Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks. Total of all reporting groups
Overall Number of Baseline Participants 196 198 394
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants 198 participants 394 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
196
 100.0%
198
 100.0%
394
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 196 participants 198 participants 394 participants
31.2  (10) 30.3  (10) 30.8  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants 198 participants 394 participants
Female
77
  39.3%
78
  39.4%
155
  39.3%
Male
119
  60.7%
120
  60.6%
239
  60.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants 198 participants 394 participants
Philippines 47 48 95
Brazil 81 81 162
Uganda 68 69 137
1.Primary Outcome
Title Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-tuberculosis (TB) Treatment - Intention-to-treat
Hide Description Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.
Time Frame 30 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 196 198
Measure Type: Number
Unit of Measure: Participants
13 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4-Month Arm, 6-Month Arm
Comments Comparison of binomial proportion of relapse: Intention-to-treat
Type of Statistical Test Non-Inferiority or Equivalence
Comments This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.051
Confidence Interval 95%
0.01 to 0.09
Estimation Comments Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.
2.Primary Outcome
Title Bacteriologic or Clinical Relapse at 30 Months After Onset of Initial Anti-TB Treatment - Per-protocol
Hide Description Patients who presented with TB after completion of study phase treatment but before the end of follow-up were classified as relapses. A bacteriologic relapse was defined as a patient who became consistently culture-positive [defined as at least 1 of the following]: (a) at least 1 sputum mycobacterial culture growing at least 10 colonies of MTB on solid medium; (b) 2 or more respiratory secretion cultures that are positive for MTB in liquid media; or (c) any culture from an extrapulmonary site that is positive for MTB during follow-up after successful completion of initial anti-TB treatment.
Time Frame 30 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Unit of Measure: Participants
13 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4-Month Arm, 6-Month Arm
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.054
Confidence Interval 95%
0.01 to 0.10
Estimation Comments Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.
3.Secondary Outcome
Title Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Intention to Treat
Hide Description A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intention to treat (ITT) analysis included all 394 fully eligible and randomized patients allocated to the shortened 4-month treatment group (N=196) or the standard 6-month treatment group (N=198). There were no allocated patients excluded in the ITT analysis dataset.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 196 198
Measure Type: Number
Unit of Measure: Participants
Treatment Failures 0 0
Relapses 13 3
4.Secondary Outcome
Title Treatment Failures or Relapses at 2 Years After Completion of TB Treatment: Per Protocol
Hide Description A culture-positive treatment failure was defined as initial culture conversion but subsequent reversion to culture positivity. A clinical treatment failure was defined as a patient with clinical and/or radiographic evidence of progressive tuberculosis not confirmed by a positive culture after 4 or more months of anti-TB treatment while still receiving treatment. Patients who defaulted before completing study treatment and returned later with culture-positive tuberculosis were termed failures after non-adherence.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The per-protocol analysis included all 370 patients (185 per treatment arm) who received the intervention, completed treatment and full follow-up and did not have exogenous reinfection of TB. The 24 excluded subjects included 2 patients with exogenous reinfection of TB, 12 lost to follow-up, 4 deaths, and 6 who did not receive the intervention.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 185 185
Measure Type: Number
Unit of Measure: Participants
Treatment Failures 0 0
Relapses 13 3
5.Secondary Outcome
Title Relapses at 1 and 2 Years
Hide Description [Not Specified]
Time Frame 1 and 2 years after successful completion of initial anti-TB treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis includes the 386 patients who received the intervention, completed treatment, and started post-treatment follow-up (193 patients in each treatment arm). Two subjects were lost after completing treatment and contributed no follow-up time, and 6 subjects did not receive the intervention so were not included in the analysis.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 193 193
Measure Type: Number
Unit of Measure: Participants
Relapses at 1 year 10 3
Relapses at 2 years 13 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4-Month Arm, 6-Month Arm
Comments Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence rate ratio
Estimated Value 3.43
Confidence Interval 95%
0.94 to 12.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 4-Month Arm, 6-Month Arm
Comments Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident rate ratio
Estimated Value 4.52
Confidence Interval 95%
1.29 to 15.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Acquired Drug Resistance in Patients Who Relapsed
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was per protocol and looked for acquired drug resistance among the 13 patients in the 4-Month Arm who relapsed and the 3 patients in the 6-Month Arm who relapsed.
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description:
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
Overall Number of Participants Analyzed 13 3
Measure Type: Number
Unit of Measure: Participants
0 0
7.Secondary Outcome
Title Immunologic: Changes in Cytokine Levels in Mycobacterium Tubercolosis (MTB) Antigen-stimulated Whole Blood Culture Supernatants - Results Are Pending
Hide Description [Not Specified]
Time Frame After 2 and 6 months of anti-TB treatment and upon relapse
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Immunologic: Store Peripheral Blood Mononuclear Cells (PBMC) - Results Are Pending
Hide Description [Not Specified]
Time Frame Pre-treatment and serum pre-treatment after 2 and 6 months of anti-TB treatment, and at the time of relapse for future immunologic analysis
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Immunologic: Changes in Sputum Cytokine Levels - Results Are Pending
Hide Description [Not Specified]
Time Frame After 1 and 2 months of anti-TB treatment
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Microbiologic: Changes in Sputum Mycobacterial mRNA - Results Are Pending
Hide Description [Not Specified]
Time Frame At 1 and 2 months of anti-TB treatment, and upon relapse
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Microbiologic: Time After Inoculation Until Culture Positive in BACTEC 460 or MGIT 960 Enriched Liquid Media After 2 Months in Treatment - Results Are Pending
Hide Description [Not Specified]
Time Frame Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 24, and 30
Outcome Measure Data Not Reported
Time Frame 6 years
Adverse Event Reporting Description Patients reported adverse events at scheduled or unscheduled visits. Adverse event forms were completed by medical officers on site
 
Arm/Group Title 4-Month Arm 6-Month Arm
Hide Arm/Group Description Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks. Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
All-Cause Mortality
4-Month Arm 6-Month Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
4-Month Arm 6-Month Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/196 (9.69%)      22/198 (11.11%)    
Cardiac disorders     
Acute Myocardial Infarction (Death)  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Coronary Arery Occlusion  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Eye disorders     
Glaucoma in Right Eye  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Panuveitis  1  1/196 (0.51%)  1 0/198 (0.00%)  0
General disorders     
Hyperhidrosis  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Injury, poisoning and procedural complications     
Gunshot Wound (Abdomen)  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Gunshot Wound to Head (Death)  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Suffocation (Death)  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Investigations     
Hospitalization (Unknown Cause of Abdominal Pain)  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Other Acquired Calcaneus Deformity  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Vocal Cord Cyst  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Nervous system disorders     
Headache (Severe Post-operative)  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Seizure  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  10/77 (12.99%)  10 13/78 (16.67%)  14
Psychiatric disorders     
Bipolar Affective Disorder  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Reproductive system and breast disorders     
Cystocele and Perineal Rupture  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Endometrial Polyp  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Fetal Death  1  1/77 (1.30%)  1 1/78 (1.28%)  1
Ovarian Cyst  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Ovarian Teratoma (Benign)  1  1/77 (1.30%)  1 1/78 (1.28%)  1
Pelvic Abcess  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Pre-eclampsia  1  0/77 (0.00%)  0 1/78 (1.28%)  1
Uterine Myoma  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopneumonia  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Hemoptysis  1  1/196 (0.51%)  2 0/198 (0.00%)  0
Pneumothorax  1  1/196 (0.51%)  1 0/198 (0.00%)  0
Skin and subcutaneous tissue disorders     
Malignant Melanoma (Death)  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Surgical and medical procedures     
Surgical Intervention on Right Shoulder  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Tracheal Plastic Repair  1  0/196 (0.00%)  0 1/198 (0.51%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
4-Month Arm 6-Month Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/196 (86.73%)      164/198 (82.83%)    
Blood and lymphatic system disorders     
Hemoptysis  1  15/196 (7.65%)  19 15/198 (7.58%)  19
Gastrointestinal disorders     
Abdominal Pain  1  48/196 (24.49%)  63 49/198 (24.75%)  59
Diarrhea  1  15/196 (7.65%)  20 10/198 (5.05%)  10
Nausea  1  20/196 (10.20%)  31 32/198 (16.16%)  41
Vomiting  1  15/196 (7.65%)  18 16/198 (8.08%)  19
General disorders     
Fever  1  87/196 (44.39%)  148 67/198 (33.84%)  103
Malaise  1  17/196 (8.67%)  22 15/198 (7.58%)  18
Rigors  1  13/196 (6.63%)  15 12/198 (6.06%)  15
Sweating  1  13/196 (6.63%)  15 17/198 (8.59%)  22
Infections and infestations     
Flu  1  40/196 (20.41%)  63 27/198 (13.64%)  46
Malaria  1  9/196 (4.59%)  12 2/198 (1.01%)  3
Tinea Infection  1  10/196 (5.10%)  12 6/198 (3.03%)  9
Metabolism and nutrition disorders     
Appetite Lost  1  39/196 (19.90%)  49 30/198 (15.15%)  35
Weight Loss  1  24/196 (12.24%)  29 20/198 (10.10%)  26
Musculoskeletal and connective tissue disorders     
Arthralgia  2  64/196 (32.65%)  92 64/198 (32.32%)  87
Back Pain  1  34/196 (17.35%)  46 31/198 (15.66%)  36
Myalgia  1  5/196 (2.55%)  5 15/198 (7.58%)  16
Pain in Limb  1  6/196 (3.06%)  8 11/198 (5.56%)  14
Nervous system disorders     
Dizziness  1  18/196 (9.18%)  20 17/198 (8.59%)  18
Headache  1  64/196 (32.65%)  102 46/198 (23.23%)  66
Psychiatric disorders     
Insomnia  1  8/196 (4.08%)  11 11/198 (5.56%)  15
Respiratory, thoracic and mediastinal disorders     
Chest Pain  1  70/196 (35.71%)  115 52/198 (26.26%)  77
Coryza  1  11/196 (5.61%)  11 10/198 (5.05%)  11
Cough  1  104/196 (53.06%)  186 90/198 (45.45%)  162
Dyspnea  1  17/196 (8.67%)  18 9/198 (4.55%)  9
Produce Sputum  1  48/196 (24.49%)  57 39/198 (19.70%)  50
Purulent Sputum  1  34/196 (17.35%)  40 27/198 (13.64%)  33
Rhinorrhea  1  12/196 (6.12%)  17 17/198 (8.59%)  19
Sore Throat  1  14/196 (7.14%)  15 10/198 (5.05%)  10
Upper Respiratory Tract Infection  1  33/196 (16.84%)  50 27/198 (13.64%)  39
Skin and subcutaneous tissue disorders     
Acne  1  14/196 (7.14%)  15 16/198 (8.08%)  17
Pruritis  1  46/196 (23.47%)  57 43/198 (21.72%)  52
Rash  1  18/196 (9.18%)  20 15/198 (7.58%)  15
Skin Lesion  1  15/196 (7.65%)  21 9/198 (4.55%)  22
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.1)
2
Term from vocabulary, MedDRA 10.1
Enrollment was stopped early and the number of patients enrolled was 1/2 of the original sample size. The study was completed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John L. Johnson, M.D., Principal Investigator
Organization: Case Western Reserve University, Tuberculosis Research Unit
Phone: (216) 368-1949
EMail: jlj@case.edu
Publications of Results:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00130247     History of Changes
Other Study ID Numbers: 01-009
First Submitted: August 12, 2005
First Posted: August 15, 2005
Results First Submitted: August 20, 2009
Results First Posted: January 27, 2010
Last Update Posted: November 8, 2018