A Phase 3 interventional study of Rifapentine (RPT) and Isoniazid (INH) in Tuberculosis and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 45 sites in 10 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Prevention
HIV-infected people have an increased risk of developing active tuberculosis (TB). At the time the study was designed, the standard course of treatment for TB was 6 to 9 months of isoniazid (INH).This study compared the safety and effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV-infected people who are at risk of developing active TB.
The World Health Organization (WHO) estimated that in 2017 there were 10 million new cases of TB, and 1.6 million people died as a result of TB. Among new TB cases, it is estimated that 920,000 occurred in people who were HIV-coinfected, and 23% of TB deaths were among HIV-coinfected individuals. In Africa, TB is the leading AIDS-related opportunistic infection. Latent TB infection occurs when people are infected with the bacteria that cause TB, but they do not have any symptoms of TB infection. Latent TB can develop into active TB, and HIV-infected people have an increased risk of progressing from latent TB to active TB. INH is a medication that is prescribed for people with latent TB to help prevent active TB from developing. The standard INH treatment regimen is 6 to 9 months; a shorter treatment regimen of 3 months of once-weekly RPT plus INH has proven to be as effective and improved adherence. The purpose of this study was to compare the safety and effectiveness of a 4-week daily regimen of RPT plus INH to a standard 9-month daily INH regimen for TB prevention in HIV-infected individuals.
This study enrolled HIV-infected people who did not have evidence of active TB but who were at high risk of developing active TB. Participants were randomly assigned to receive RPT and INH once a day for 4 weeks or INH once a day for 9 months. All participants received pyridoxine (vitamin B6) with each dose of INH to help prevent possible side effects. Study visits occurred at baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 36. At select study visits, participants had a physical exam, clinical assessment, blood collection, and a chest radiograph or chest computed tomography (CT) scan (if needed). Some participants had their blood stored for future testing. Follow-up study visits occurred every 12 weeks starting at Week 48 and continued for 3 years after the last participant enrolled.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 3,000 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Laboratory values obtained within 30 days prior to study entry:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received RPT (dosage based on their weight), 300 mg of INH, and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 4. During Weeks 5 to 36, participants did not receive any study medications.
Drug: Rifapentine (RPT) · Drug: Isoniazid (INH) · Dietary Supplement: Pyridoxine (Vitamin B6)
Participants received 300 mg of INH and 25 mg or 50 mg of pyridoxine (vitamin B6) each day during Weeks 1 to 36.
Drug: Isoniazid (INH) · Dietary Supplement: Pyridoxine (Vitamin B6)
RPT dosing was be based on participants' weight: Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets). Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets). Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets).
Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines. Participants who received 25 mg of pyridoxine took one 25-mg tablet once daily with INH. Participants who received 50 mg of pyridoxine took two 25-mg tablets once daily with INH.
Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
Time frame: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs
Occurrence of any SAE that meets the ICH definition of an SAE
Time frame: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Number of Participants With a Targeted Adverse Event
Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), or bilirubin; and peripheral neuropathy
Time frame: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period
Ordered categories include: 1. Premature permanent treatment discontinuation 2. Treatment hold for more than 7 consecutive days 3. None of the above
Time frame: From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B)
Cumulative Incidence of Death From Any Cause
Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
Time frame: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Cumulative Incidence of Death Due to a Non-TB Event
Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
Time frame: From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)
Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis
Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
Time frame: After TB diagnosis
Efavirenz (EFV) Plasma Concentrations in Arm A
Mean and standard deviation. Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.
Time frame: Measured at Weeks 0, 2, 4, and 16
Nevirapine (NVP) Plasma Concentrations in Arm A
Mean and standard deviation
Time frame: Measured at Weeks 0, 2, and 4
EFV Plasma Concentrations in Arm B
For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.
Time frame: Measured at weeks 0, 2 and 4
Forty-five Clinical Research sites across 10 countries participated in the study. The first participant was randomized on May 23, 2012. Accrual closed on November 12, 2014 with 3,000 participants enrolled in the study.
| Milestone | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Started | 1496 | 1504 |
| Completed | 1198 | 1193 |
| Not completed | 298 | 311 |
| Withdrew: Death | 21 | 27 |
| Withdrew: Withdrawal by subject | 15 | 18 |
| Withdrew: Participant unable to get to clinic | 93 | 103 |
| Withdrew: Lost to follow-up | 115 | 111 |
| Withdrew: Site closed | 22 | 21 |
| Withdrew: Participant not willing to adhere to req | 31 | 29 |
| Withdrew: Severe debilitation, unable to continue | 1 | 2 |
Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.
| Events per 100 person-years | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause | 0.6506 (0.4242 to 0.8770) | 0.6736 (0.4428 to 0.9045) |
Occurrence of any SAE that meets the ICH definition of an SAE
| Participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| No SAE occurred | 1405 | 1390 |
| At least one SAE occurred | 83 | 108 |
Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), or bilirubin; and peripheral neuropathy
| Participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| No Targeted Safety Event | 1445 | 1446 |
| Occurrence of Targeted Safety Event | 43 | 52 |
Ordered categories include: 1. Premature permanent treatment discontinuation 2. Treatment hold for more than 7 consecutive days 3. None of the above
| Participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Premature permanent treatment discontinuation | 16 | 25 |
| Treatment held for more than 7 days | 11 | 31 |
| None of the above | 1461 | 1442 |
Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.
| events per 100 participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| 1 year post-entry | 0.35 | 0.63 |
| 2 years post-entry | 0.49 | 1.15 |
| 3 years post-entry | 1.05 | 1.62 |
| 4 years post-entry | 2.00 | 2.29 |
Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.
| events per 100 participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Cumulative incidence by 1 year post-randomization | 0.3 | 0.5 |
| Cumulative incidence by 2 years post-randomization | 0.4 | 1.0 |
| Cumulative incidence by 3 years post-randomization | 0.9 | 1.5 |
| Cumulative incidence by 4 years post-randomization | 1.6 | 2.0 |
Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.
| Participants | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Rifampin — Developed Resistance | 1 | 1 |
| Rifampin — Did not Develop Resistance | 14 | 11 |
| Isoniazid — Developed Resistance | 2 | 1 |
| Isoniazid — Did not Develop Resistance | 12 | 11 |
| Ethambutol — Developed Resistance | 0 | 1 |
| Ethambutol — Did not Develop Resistance | 7 | 7 |
| Pyrazinamide — Developed Resistance | 0 | 0 |
| Pyrazinamide — Did not Develop Resistance | 6 | 6 |
Mean and standard deviation. Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019.
| nanograms per mL | RPT Plus INH Regimen (Arm A) |
|---|---|
| Week 0 | 3787 ± 4922 |
| Week 2 | 3870 ± 7011 |
| Week 4 | 4082 ± 4916 |
Mean and standard deviation
| nanograms per mL | RPT Plus INH Regimen (Arm A) |
|---|---|
| Week0 | 7573 ± 3789 |
| Week 2 | 6234 ± 4283 |
| Week 4 | 5797 ± 3963 |
For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria. Outcome measure was not assessed because no participants enrolled under version 2.0 of the protocol were on Efavirenz at study entry.
No measurements were reported for this outcome.
Collected over From entry to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RPT Plus INH Regimen (Arm A) | 21/1,496 (1.4%) | 40/1,496 (2.7%) | 1,051/1,496 (70.3%) |
| INH Regimen (Arm B) | 27/1,504 (1.8%) | 68/1,504 (4.5%) | 1,042/1,504 (69.3%) |
| Event | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| Hepatic enzyme increasedInvestigations | 1/1496 | 7/1504 |
| NeutropeniaBlood and lymphatic system disorders | 5/1496 | 0/1504 |
| SeizureNervous system disorders | 0/1496 | 4/1504 |
| AnaemiaBlood and lymphatic system disorders | 2/1496 | 3/1504 |
| HepatotoxicityHepatobiliary disorders | 2/1496 | 0/1504 |
| Transaminases increasedInvestigations | 2/1496 | 0/1504 |
| DehydrationMetabolism and nutrition disorders | 2/1496 | 0/1504 |
| Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1496 | 0/1504 |
| Suicide attemptPsychiatric disorders | 2/1496 | 1/1504 |
| RashSkin and subcutaneous tissue disorders | 2/1496 | 1/1504 |
| Event | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 254/1496 | 238/1504 |
| Blood sodium decreasedInvestigations | 219/1496 | 200/1504 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 202/1496 | 166/1504 |
| PyrexiaGeneral disorders | 198/1496 | 187/1504 |
| Neutrophil count decreasedInvestigations | 189/1496 | 146/1504 |
| HeadacheNervous system disorders | 155/1496 | 149/1504 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 122/1496 | 130/1504 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 125/1496 | 123/1504 |
| Blood albumin decreasedInvestigations | 97/1496 | 125/1504 |
| Alanine aminotransferase increasedInvestigations | 102/1496 | 121/1504 |
All enrolled participants
| Age, Continuous(years) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Mean | 35.7 ± 10.3 | 35.6 ± 10.3 | 35.7 ± 10.3 |
| Age, Customized(Participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Age at Entry — <=20 years | 77 | 70 | 147 |
| Age at Entry — >20, <=30 years | 421 | 455 | 876 |
| Age at Entry — >30, <=40 years | 523 | 514 | 1037 |
| Age at Entry — >40, <=50 years | 342 | 331 | 673 |
| Age at Entry — >50 years | 133 | 134 | 267 |
| Sex: Female, Male(Participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Female | 802 | 812 | 1614 |
| Male | 694 | 692 | 1386 |
| Race/Ethnicity, Customized(Participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Race/Ethnicity — White Non-Hispanic | 16 | 12 | 28 |
| Race/Ethnicity — Black Non-Hispanic | 992 | 991 | 1983 |
| Race/Ethnicity — Hispanic (Regardless of Race) | 361 | 369 | 730 |
| Race/Ethnicity — Asian, Pacific Islander | 122 | 128 | 250 |
| Race/Ethnicity — Not Reported | 5 | 4 | 9 |
| Region of Enrollment(participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Haiti | 198 | 198 | 396 |
| United States | 45 | 46 | 91 |
| Malawi | 106 | 108 | 214 |
| Botswana | 210 | 212 | 422 |
| Brazil | 102 | 98 | 200 |
| South Africa | 307 | 309 | 616 |
| Zimbabwe | 56 | 58 | 114 |
| Kenya | 93 | 94 | 187 |
| Thailand | 121 | 124 | 245 |
| Peru | 258 | 257 | 515 |
| Body Mass Index (BMI)(kg/m^2) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Mean | 24.6 ± 5.2 | 24.5 ± 5.3 | 24.5 ± 5.2 |
| IV Drug Use(Participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Never | 1489 | 1497 | 2986 |
| Currently | 2 | 1 | 3 |
| Previously | 5 | 6 | 11 |
| Prior Tuberculosis History(Participants) | RPT Plus INH Regimen (Arm A) | INH Regimen (Arm B) | Total |
|---|---|---|---|
| Yes | 82 | 89 | 171 |
| No | 1414 | 1415 | 2829 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifapentine
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