A Phase 2 interventional study of Rifapentine and Rifampicin in HIV and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 6 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
The purpose of this study was to compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) regimen for drug-susceptible (DS) tuberculosis (TB).
This study compared a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with a CFZ loading dose with the 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).
Randomization was stratified based on HIV status and the presence of advanced disease as determined by chest X-ray.
Participants were randomized to one of three arms:
All participants received pyridoxine (vitamin B6) with each dose of isoniazid (INH) based on current local, national or international dosing guidelines.
Arm 1 participants were treated for 13 weeks (including a 2-week CFZ loading dose of 300 mg daily). Arm 2 participants were treated for 26 weeks, and Arm C participants were treated for 4 weeks.
All participants in Arms 1, 2, and C were followed from randomization to Week 65.
On June 1, 2023, the Data and Safety Monitoring Board (DSMB) recommended that the study permanently close to accrual because of the high rate of treatment failure and TB recurrence. The A5362 team, NIAID and DAIDS leadership, and ACTG leadership concurred with the DSMB's recommendation and the study was closed to accrual on June 2, 2023. A letter of amendment was created that extended follow-up to 117 weeks for some participants in Arm 1.
Due to the early close to accrual, a primary analysis report forming the basis of the primary trial manuscript used data collected at study visits up to and including the date when the last enrolled participant completed the week 26 study visit (September 25. 2023). Another final analysis was performed using data collected at study visits up to the date when the last enrolled participant completed the week 65 assessment.
Study visits included physical examinations; blood, urine, and/or sputum collection; chest X-rays; and electrocardiograms (ECG).
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 104 is below 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.
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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.
Pulmonary TB (among participants with or without history of prior TB treatment) identified within 5 days prior to entry by:
The following laboratory values obtained at or within 5 days prior to entry by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent, or at any network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practice (GCLP) and participates in appropriate external quality assurance programs.
Female participants of reproductive potential must agree not to participate in the conception process (i.e., active attempt to become pregnant, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable nonhormonal method of , as listed below, while on study treatment and for 30 days after stopping study medications.
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 CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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 rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) + clofazimine (CFZ) 300 mg once daily for 2 weeks; then PHZE + CFZ 100 mg once daily for 6 weeks; then rifapentine/isoniazid/pyrazinamide (PHZ) + CFZ 100 mg once daily for 5 weeks.
Drug: Rifapentine · Drug: Isoniazid · Drug: Pyrazinamide · Drug: Ethambutol · Drug: Clofazimine loading dose
Participants received rifampicin/isoniazid/pyrazinamide/ethambutol (RHZE) for 8 weeks; then rifampicin/isoniazid (RH) for 18 weeks.
Drug: Rifampicin · Drug: Isoniazid · Drug: Pyrazinamide · Drug: Ethambutol
Participants received PHZE + CFZ 100 mg once daily for 4 weeks; then remained on study, and were treated with off study medications according to local SOC (RHZE for 4 weeks; then RH for 18 weeks).
Drug: Rifapentine · Drug: Isoniazid · Drug: Pyrazinamide · Drug: Ethambutol · Drug: Clofazimine 100 MG
1200 mg once daily
600 mg once daily
300 mg once daily
1000mg once daily if weight is 40 to \<55kg; 1500mg once daily if weight is 55 to \<71kg; 2000mg once if weight is ≥71kg
800 mg once daily if weight is 40 to \<55kg; 1200 mg once daily if weight is 55 to \<71kg; 1600mg once if weight is ≥71kg
300 mg once daily for 2 weeks (loading dose), then 100 mg once daily
100 mg once daily
Time to 12 Weeks Stable Culture Conversion in Liquid Media
The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB. If a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion they were censored at 12 weeks. Participants who were lost to follow-up prior to 12 weeks with their last culture being positive were censored at 12 weeks (i.e. assumed they did not have a culture conversion by week 12), and participants who were lost to follow-up prior to 12 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.
Time frame: From Entry through Week 12
Participants Experiencing Any Grade 3 or Higher Adverse Event (AE) That is at Least a One Grade Increase From Baseline Over 65 Weeks
An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1, Corrected Version 2.1, July 2017) The primary manuscript outcome measure includes data through week 65 up to September 25, 2023
Time frame: From entry through Week 65
Proportion of Participants With Favorable Clinical/Bacteriologic Outcome (Definition A) at 65 Weeks Post-randomization
Favorable Outcome are: * liquid culture negative at week 65 * without signs or symptoms of ongoing active TB and unable to produce sputum at 65 weeks * who at the end of the follow-up period are clinically without signs/symptoms of ongoing active TB and produce a sputum specimen that is contaminated in two liquid cultures without evidence of TB Unfavorable: * Absence of cure: Having a sputum sample at or after EOT that is culture-positive (any medium) with a second positive sample obtained 4 hours following the first sample. * Death from any cause except for violent or accidental cause * Had a positive culture for Mtb when last seen * Had a treatment extension beyond nominal level due to clinically inadequate response Unevaluable are: * lost to follow-up during treatment or post-treatment with their last culture being negative for Mtb * violent or accidental death * becoming pregnant during their assigned active treatment and stop their assigned treatment.
Time frame: From entry through Week 65
Proportion of Participants With Favorable Composite Outcome (Definition B) at 65 Weeks Post-randomization
Favorable Outcome are: Same as definition A Unfavorable: Same as definition A and: * lost to follow-up during treatment phase * failing to complete treatment * receiving any one or more of the following: extension of treatment beyond the nominal level, except to make up missed doses; re-starting treatment following \>= 30 consecutive days lost to follow-up; a change in at least one drug in treatment regimen for any reason except re-infection, pregnancy, or temporary drug challenge Unevaluable are: * lost to follow-up after treatment phase, and not assessable at the end of follow-up, with their last culture being negative for Mtb * Violent death or accidental death * Women who become pregnant during their assigned active treatment and stop their assigned treatment
Time frame: From entry through Week 65
Number of Participants Who Prematurely Discontinue Their Treatment Regimen Through 65 Weeks
Premature discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring
Time frame: From entry through Week 65
Mean QTcF
QT interval measured as the average of three electrocardiogram (ECG) readings taken 5-10 minutes apart, corrected with Fridericia correction
Time frame: Measured at Weeks 2, 8, and 13 (end of investigational treatment)
QTcF Interval Mean Change From Baseline
Mean change from baseline in mean QTcF at weeks 2, 8, and end of treatment (EOT)
Time frame: Measured at baseline and Weeks 2, 8, and 13 (end of investigational treatment)
Categorized QTcF
Absolute QTcF was categorized as:\< 480; ≥480 ms and \<500 ms; ≥500 ms
Time frame: Week 2, 8, and Week 13
Categorized Change From Baseline
Categorized change from baseline as: change from baseline of \<30 ms; change from baseline of ≥30 ms and \<60 ms; change from baseline of ≥60 ms
Time frame: Measured at Weeks 2, 8, and Week 13
Time to Stable Culture Conversion in Liquid Media Through Week 65
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
Time frame: From entry through Week 65
Time to Stable Culture Conversion in Solid Media Through Week 65
The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB. If a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion, the death was considered as a competing event. Participants who were lost to follow-up prior to 65 weeks with their last culture being positive were censored at 65 weeks (i.e. assumed they did not have a culture conversion by week 65), and participants who were lost to follow-up prior to 65 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result. Adjusted model adjusts for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).
Time frame: From entry through Week 65
Number of Participants Achieving Stable Liquid Culture Conversion by Week 8
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
Time frame: From entry through Week 8
Number of Participants Achieving Stable Solid Culture Conversion by Week 8
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
Time frame: From entry through Week 8
Number of Participants With One or More Serious Adverse Events (SAEs)
Cumulative proportion with at least one Serious Adverse Event (SAE) A SAE is defined as any untoward medical occurrence that: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event that many not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.
Time frame: From entry through Week 65
Number of Participants Achieving Stable Solid Culture Conversion by Week 12
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
Time frame: From entry through Week 12
Median Time (Days) to Positivity in Liquid Culture (MGIT)
Time (days) to positivity in liquid culture (MGIT) is defined as the number of days it takes for the culture to produce results up to a max of 42 days. For negative culture results, time to positivity is imputed as 42 days.
Time frame: From screening, entry, weeks 1, 2, 3, 4, 6, 8, 10, 12
Change in Chest X-ray Score From Baseline to End of Treatment in Each Arm
The chest X-ray was posterior-anterior. Extent of disease (limited to one lobe or region, unilateral, bilateral, or diffuse) and cavitation status (cavities present \[location\] or absent) was documented by validated numerical score (percent of total lung affected by any pathology + 40 if cavitation is present; 0 = No percent affected, 140 = entire lung is affected + cavitation is present) for grading chest X-ray in adult smear-positive pulmonary TB (Thorax 2010; 65(10):863-9). Analysis was conducted based on site readings of CXR
Time frame: Entry, End of Treatment (Week 13 for Arm 1 and Week 26 for Arm 2)
Proportion of Participants Who Have a TB Relapse, From End of Treatment Until Week 65
The time of relapse is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media for an Mtb strain that has matching genotype with the baseline isolate (as determined by whole genome sequencing). A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a relapse. If the second sputum sample was negative, this was not counted as a relapse. If a participant was lost to follow-up without a second sputum sample confirmation of relapse (including contaminated or missing), it was counted as a relapse. Whole genome sequencing of samples, which is necessary to assess TB relapse, was not performed due to lack of funding. There is no plan to test these samples in the future.
Time frame: From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65
Cumulative Proportion of Participants Who Have a TB Recurrence, From End of Treatment Until Week 65
The time of recurrence is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media. A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a recurrence. If the second sputum sample was negative, this will not be counted as a recurrence. If a participant was lost to follow-up without a second sputum sample confirmation of recurrence (including contaminated or missing), it was counted as a recurrence. Participants at risk for recurrence where those who were stable culture conversions by end of treatment.
Time frame: From end of treatment (week 13 for Arm 1; week 26 for Arm 2) to week 65
Pharmacokinetic Parameter for CFZ: Minimum Concentration (Cmin)
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
Time frame: Measured at Weeks 2 and 13
Pharmacokinetic Parameter for CFZ: Maximum Concentration (Cmax)
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
Time frame: Measured at Weeks 2 and 13
Pharmacokinetic Parameter for CFZ: Time of Cmax (Tmax)
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
Time frame: Measured at Weeks 2 and 13
Pharmacokinetic Parameter for CFZ: Area Under the Concentration Curve (AUC0-24h)
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
Time frame: Measured at Weeks 2 and 13
Mean Change From Baseline in Skin Pigmentation (Colorimetric L*)
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). L represents lightness (0 = black, 100 = white). Further data processing removed values if one of the triplicates differed more than 5% of the median.
Time frame: Entry, Weeks 8, 13, 26, and 65
Mean Change From Baseline in Skin Pigmentation (Colorimetric a*)
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The a\* parameter represents the balance between red and green. Positive values of a\* indicate a reddish tone, while negative values indicate a greenish tone. (-128 = Green, 127 = Red). Further data processing removed values if one of the triplicates differed more than 5% of the median.
Time frame: Entry, Weeks 8, 13, 26, and 65
Mean Change From Baseline in Skin Pigmentation (Colorimetric b*)
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The b\* parameter represents the balance between yellow and blue. Positive values of b\* indicate a yellowish tone, while negative values indicate a bluish tone (-128 = Blue, 127 = Yellow). Further data processing removed values if one of the triplicates differed more than 5% of the median.
Time frame: Entry, Weeks 8, 13, 26, and 65
Change From Baseline in Participant-reported Changes in Skin Pigment Related to Perceived Skin Hyperpigmentation
Subjective questionnaire asked the following questions : 1.) On a scale from 0 to 10: (0 being none and 10 being most significant possible) How would you rate any change in the coloration of your skin since you began TB treatment?
Time frame: Entry, Weeks 8, 13, 26, and 65
Change From Baseline in Participant-reported Distress Caused by Change in Skin Pigment Related to Perceived Skin Hyperpigmentation
Subjective questionnaire asked the following questions: On a scale from 0 to 10: (0 being none and 10 being worst possible) How would you rate your distress to skin coloration changes since you began TB treatment, if any?
Time frame: Entry, Weeks 8, 13, 26, and 65
Participants were enrolled from November 2021 to March 2023 in 6 sites located in Malawi (2 sites), South Africa, Zimbabwe, India, and Haiti. A screening and accrual pause was instated on April 4, 2023 and subsequently formally closed to accrual on June 2, 2023 in response to recommendations from the DSMB.
| Milestone | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup |
|---|---|---|---|
| Started | 58 | 31 | 15 |
| Started treatment and were not late exclusions | 55 | 31 | 15 |
| Completed | 22 | 27 | 14 |
| Not completed | 36 | 4 | 1 |
| Withdrew: Death | 1 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 3 | 0 |
| Withdrew: Participant is in prison | 1 | 0 | 0 |
| Withdrew: Participant moved out of country | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Dsmb mandated extension of follow-up | 29 | 0 | 0 |
| Milestone | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup |
|---|---|---|---|
| Started | 29 | 0 | 0 |
| Completed | 27 | 0 | 0 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 |
The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB. If a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion they were censored at 12 weeks. Participants who were lost to follow-up prior to 12 weeks with their last culture being positive were censored at 12 weeks (i.e. assumed they did not have a culture conversion by week 12), and participants who were lost to follow-up prior to 12 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result.
| weeks | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Time to 12 Weeks Stable Culture Conversion in Liquid Media | 6 (4 to 8) | 8 (6 to 10) |
An adverse event is any unfavorable and unintended sign, symptom, or diagnosis that occurs in a study participant during the conduct of the study REGARDLESS of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. AE grading was per Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table V2.1, Corrected Version 2.1, July 2017) The primary manuscript outcome measure includes data through week 65 up to September 25, 2023
| Participants | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup |
|---|---|---|---|
| Number of Participants through Primary Manuscript Cutoff date of September 25, 2023 | 26 | 5 | 3 |
| Number of Participants through Week 65 | 27 | 6 | 3 |
Favorable Outcome are: * liquid culture negative at week 65 * without signs or symptoms of ongoing active TB and unable to produce sputum at 65 weeks * who at the end of the follow-up period are clinically without signs/symptoms of ongoing active TB and produce a sputum specimen that is contaminated in two liquid cultures without evidence of TB Unfavorable: * Absence of cure: Having a sputum sample at or after EOT that is culture-positive (any medium) with a second positive sample obtained 4 hours following the first sample. * Death from any cause except for violent or accidental cause * Had a positive culture for Mtb when last seen * Had a treatment extension beyond nominal level due to clinically inadequate response Unevaluable are: * lost to follow-up during treatment or post-treatment with their last culture being negative for Mtb * violent or accidental death * becoming pregnant during their assigned active treatment and stop their assigned treatment.
| proportion of participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Proportion of Participants With Favorable Clinical/Bacteriologic Outcome (Definition A) at 65 Weeks Post-randomization | .50 (0.35 to 0.62) | .76 (.56 to .88) |
Favorable Outcome are: Same as definition A Unfavorable: Same as definition A and: * lost to follow-up during treatment phase * failing to complete treatment * receiving any one or more of the following: extension of treatment beyond the nominal level, except to make up missed doses; re-starting treatment following \>= 30 consecutive days lost to follow-up; a change in at least one drug in treatment regimen for any reason except re-infection, pregnancy, or temporary drug challenge Unevaluable are: * lost to follow-up after treatment phase, and not assessable at the end of follow-up, with their last culture being negative for Mtb * Violent death or accidental death * Women who become pregnant during their assigned active treatment and stop their assigned treatment
| proportion of participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Proportion of Participants With Favorable Composite Outcome (Definition B) at 65 Weeks Post-randomization | 0.49 (0.35 to 0.61) | 0.74 (0.54 to 0.86) |
Premature discontinuation is defined as discontinuation other than due to violent death, natural disaster, or administrative censoring
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Number of Participants Who Prematurely Discontinue Their Treatment Regimen Through 65 Weeks | 2 | 3 |
QT interval measured as the average of three electrocardiogram (ECG) readings taken 5-10 minutes apart, corrected with Fridericia correction
| ms | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Mean QTcF Interval at Week 2 | 419 ± 19.4 | 401 ± 14.8 |
| Mean QTcF Interval at Week 8 | 422 ± 16.8 | 408 ± 16.8 |
| Mean QTcF Interval at Week 13 | 427 ± 19.5 | 407 ± 20.4 |
Mean change from baseline in mean QTcF at weeks 2, 8, and end of treatment (EOT)
| ms | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Change in mean QTcF from Week 2 to Screening | 23.9 ± 21.2 | 0.736 ± 19.8 |
| Change in mean QTcF from Week 8 to Screening | 26.5 ± 20.1 | 7.38 ± 14.6 |
| Change in mean QTcF from Week 13 to Screening | 31.6 ± 20.7 | 7.77 ± 19.0 |
Absolute QTcF was categorized as:\< 480; ≥480 ms and \<500 ms; ≥500 ms
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Week 2 — Absolute QTcF ≥480 ms and <500 ms | 0 | 0 |
| Week 2 — Absolute QTcF ≥500 ms | 0 | 0 |
| Week 2 — Absolute QTcF < 480 ms | 56 | 29 |
| Week 8 — Absolute QTcF ≥480 ms and <500 ms | 0 | 0 |
| Week 8 — Absolute QTcF ≥500 ms | 0 | 0 |
| Week 8 — Absolute QTcF < 480 ms | 54 | 31 |
| Week 13 — Absolute QTcF ≥480 ms and <500 ms | 0 | 0 |
| Week 13 — Absolute QTcF ≥500 ms | 0 | 0 |
| Week 13 — Absolute QTcF < 480 ms | 55 | 30 |
Categorized change from baseline as: change from baseline of \<30 ms; change from baseline of ≥30 ms and \<60 ms; change from baseline of ≥60 ms
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Week 2 — QTcF change from baseline of ≥30 ms and <60 ms | 15 | 1 |
| Week 2 — QTcF change from baseline of ≥60 ms | 2 | 0 |
| Week 2 — QTcF change from baseline of <30 ms | 39 | 28 |
| Week 8 — QTcF change from baseline of ≥30 ms and <60 ms | 17 | 2 |
| Week 8 — QTcF change from baseline of ≥60 ms | 1 | 0 |
| Week 8 — QTcF change from baseline of <30 ms | 36 | 29 |
| Week 13 — QTcF change from baseline of ≥30 ms and <60 ms | 22 | 3 |
| Week 13 — QTcF change from baseline of ≥60 ms | 5 | 0 |
| Week 13 — QTcF change from baseline of <30 ms | 28 | 27 |
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
| weeks | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Time to Stable Culture Conversion in Liquid Media Through Week 65 | 6 (4 to 8) | 8 (6 to 10) |
The time of stable culture conversion was the visit corresponding to the first of two consecutive negative cultures without an intervening positive, and/or visits wherein the participant was unable to produce sputum and had no signs of active TB. If a participant did not culture convert, they were censored at their last culture result (regardless of result). If a participant died before conversion, the death was considered as a competing event. Participants who were lost to follow-up prior to 65 weeks with their last culture being positive were censored at 65 weeks (i.e. assumed they did not have a culture conversion by week 65), and participants who were lost to follow-up prior to 65 weeks with their last culture being negative were censored at the last sampling visit for which they had a valid culture result. Adjusted model adjusts for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).
| weeks | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Time to Stable Culture Conversion in Solid Media Through Week 65 | 6 (2 to 8) | 6 (4 to 8) |
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Number of Participants Achieving Stable Liquid Culture Conversion by Week 8 | 41 | 19 |
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Number of Participants Achieving Stable Solid Culture Conversion by Week 8 | 47 | 25 |
Cumulative proportion with at least one Serious Adverse Event (SAE) A SAE is defined as any untoward medical occurrence that: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event that many not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above.
| Participants | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup |
|---|---|---|---|
| Number of Participants With One or More Serious Adverse Events (SAEs) | 8 | 2 | 2 |
Defined as the first of two (consecutive or non-consecutive) negative sputum cultures without an intervening positive culture, and/or visits wherein the participant is unable to produce sputum and has no signs of active TB
| Participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Number of Participants Achieving Stable Solid Culture Conversion by Week 12 | 53 | 30 |
Time (days) to positivity in liquid culture (MGIT) is defined as the number of days it takes for the culture to produce results up to a max of 42 days. For negative culture results, time to positivity is imputed as 42 days.
| days | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Screening Time to Positivity | 6.17 (3.83 to 7.67) | 5.67 (4.04 to 8.08) |
| Entry Time to Positivity | 8.63 (6.67 to 11.2) | 8.23 (7.21 to 10.3) |
| Week 1 Time to Positivity | 12.8 (7.33 to 18.3) | — |
| Week 2 Time to Positivity | 16.8 (11.8 to 22.4) | 12.1 (9.96 to 18.9) |
| Week 3 Time to Positivity | 20.2 (8.29 to 42) | — |
| Week 4 Time to Positivity | 25.1 (16.8 to 42) | 16.5 (14.4 to 38) |
| Week 6 Time to Positivity | 42 (27.2 to 42) | 42 (17.6 to 42) |
| Week 8 Time to Positivity | 42 (42 to 42) | 42 (26.7 to 42) |
| Week 10 Time to Positivity | 42 (42 to 42) | 42 (42 to 42) |
| Week 12 Time to Positivity | 42 (42 to 42) | 42 (42 to 42) |
The chest X-ray was posterior-anterior. Extent of disease (limited to one lobe or region, unilateral, bilateral, or diffuse) and cavitation status (cavities present \[location\] or absent) was documented by validated numerical score (percent of total lung affected by any pathology + 40 if cavitation is present; 0 = No percent affected, 140 = entire lung is affected + cavitation is present) for grading chest X-ray in adult smear-positive pulmonary TB (Thorax 2010; 65(10):863-9). Analysis was conducted based on site readings of CXR
| score on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Change in Chest X-ray Score From Baseline to End of Treatment in Each Arm | -25.51 (-34.27 to -16.75) | -46.10 (-58.04 to -34.16) |
The time of relapse is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media for an Mtb strain that has matching genotype with the baseline isolate (as determined by whole genome sequencing). A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a relapse. If the second sputum sample was negative, this was not counted as a relapse. If a participant was lost to follow-up without a second sputum sample confirmation of relapse (including contaminated or missing), it was counted as a relapse. Whole genome sequencing of samples, which is necessary to assess TB relapse, was not performed due to lack of funding. There is no plan to test these samples in the future.
No measurements were reported for this outcome.
The time of recurrence is defined as the time from end of treatment until the first sputum sample that is culture positive in liquid or solid media. A second positive sputum sample obtained at least 4 hours following the first sputum collection is required to confirm a recurrence. If the second sputum sample was negative, this will not be counted as a recurrence. If a participant was lost to follow-up without a second sputum sample confirmation of recurrence (including contaminated or missing), it was counted as a recurrence. Participants at risk for recurrence where those who were stable culture conversions by end of treatment.
| proportion of participants | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Within 26 Weeks of Treatment Completion | 0.21 (0.12 to 0.35) | 0.04 (0.01 to 0.24) |
| Within 39 Weeks of Treatment Completion | 0.23 (0.13 to 0.37) | 0.04 (0.01 to 0.24) |
| Within 52Weeks of Treatment Completion | 0.23 (0.13 to 0.37) | — |
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
| mg/L | Arm 1: Experimental | Arm C: PK Only Subgroup |
|---|---|---|
| Week 2 | 0.473 ± 0.181 | 0.169 ± 0.088 |
| Week 13 | 0.594 ± 0.197 | — |
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
| mg/L | Arm 1: Experimental | Arm C: PK Only Subgroup |
|---|---|---|
| Week 2 | 0.861 ± 0.286 | 0.277 ± 0.123 |
| Week 13 | 0.819 ± 0.247 | — |
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
| hours | Arm 1: Experimental | Arm C: PK Only Subgroup |
|---|---|---|
| Week 2 | 4.97 ± 2.10 | 7.74 ± 4.90 |
| Week 13 | 7.27 ± 4.68 | — |
Estimated using noncompartmental methods applied to concentrations from intensive PK sampling visits at weeks 2 and 13.
| mg/L*h | Arm 1: Experimental | Arm C: PK Only Subgroup |
|---|---|---|
| Week 2 | 15.6 ± 5.58 | 5.42 ± 2.48 |
| Week 13 | 16.9 ± 5.57 | — |
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). L represents lightness (0 = black, 100 = white). Further data processing removed values if one of the triplicates differed more than 5% of the median.
| units on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Inner Arm - Week 8 | -2.54 ± 2.51 | -1.65 ± 2.17 |
| Inner Arm - Week 13 | -4.72 ± 3.1 | 0.02 ± 2.74 |
| Inner Arm - Week 26 | -2.8 ± 3 | -0.68 ± 2.54 |
| Inner Arm - Week 65 | -1.15 ± 3.45 | 1.19 ± 3.52 |
| Face - Week 8 | -3 ± 2.30 | -0.96 ± 2.16 |
| Face - Week 13 | -3.61 ± 2.86 | -0.51 ± 1.97 |
| Face - Week 26 | -2.65 ± 2.5 | -0.43 ± 2.16 |
| Face - Week 65 | -0.45 ± 2.96 | 0.34 ± 2.31 |
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The a\* parameter represents the balance between red and green. Positive values of a\* indicate a reddish tone, while negative values indicate a greenish tone. (-128 = Green, 127 = Red). Further data processing removed values if one of the triplicates differed more than 5% of the median.
| units on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Inner Arm - Week 8 | 0.23 ± 5.86 | .20 ± 2.44 |
| Inner Arm - Week 13 | 2.14 ± 8.61 | -0.34 ± 6.40 |
| Inner Arm - Week 26 | -1.09 ± 5.72 | -1.01 ± 4.97 |
| Inner Arm - Week 65 | -0.96 ± 5.51 | -1.37 ± 5.96 |
| Face - Week 8 | -0.58 ± 1.86 | -0.09 ± 3.77 |
| Face - Week 13 | -0.46 ± 2.99 | -0.28 ± 1.19 |
| Face - Week 26 | -0.66 ± 1.71 | -0.43 ± 1.56 |
| Face - Week 65 | -0.23 ± 2.20 | 0.23 ± 2.01 |
The median of triplicate measurements of Inner Arm, and Face (median of all measurements from the Chin, Forehead, Left Cheek, and Right Cheek). The b\* parameter represents the balance between yellow and blue. Positive values of b\* indicate a yellowish tone, while negative values indicate a bluish tone (-128 = Blue, 127 = Yellow). Further data processing removed values if one of the triplicates differed more than 5% of the median.
| units on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Inner Arm - Week 8 | -1.62 ± 3.49 | -1.21 ± 3.07 |
| Inner Arm - Week 13 | -2.27 ± 3.38 | 0.11 ± 4.28 |
| Inner Arm - Week 26 | -1.52 ± 4.50 | -0.71 ± 3.86 |
| Inner Arm - Week 65 | -1.70 ± 3.37 | -1.29 ± 4.06 |
| Face - Week 8 | -2.48 ± 2.15 | -0.82 ± 2.97 |
| Face - Week 13 | -2.65 ± 2.75 | -0.66 ± 2.44 |
| Face - Week 26 | -2.44 ± 2.89 | -0.92 ± 2.55 |
| Face - Week 65 | -1.72 ± 2.52 | -0.88 ± 2.17 |
Subjective questionnaire asked the following questions : 1.) On a scale from 0 to 10: (0 being none and 10 being most significant possible) How would you rate any change in the coloration of your skin since you began TB treatment?
| score on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Week 8 | 1.60 ± 2.65 | 0.53 ± 1.11 |
| Week 13 | 2.15 ± 2.65 | 0.17 ± 0.54 |
| Week 26 | 0.53 ± 1.41 | 0.79 ± 1.95 |
| Week 65 | 0.25 ± 1.60 | 0.38 ± 1.68 |
Subjective questionnaire asked the following questions: On a scale from 0 to 10: (0 being none and 10 being worst possible) How would you rate your distress to skin coloration changes since you began TB treatment, if any?
| score on a scale | Arm 1: Experimental | Arm 2: Standard of Care |
|---|---|---|
| Week 8 | 1.02 ± 2.48 | 0.17 ± 0.75 |
| Week 13 | 0.89 ± 2.01 | -0.07 ± 0.26 |
| Week 26 | 0.21 ± 1.52 | 0.07 ± 0.80 |
| Week 65 | 0.21 ± 1.70 | 0.15 ± 0.88 |
Collected over From entry through study completion, up to 117 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 1/58 (1.7%) | 8/58 (13.8%) | 25/58 (43.1%) |
| Arm 2 | 1/31 (3.2%) | 2/31 (6.5%) | 7/31 (22.6%) |
| Arm C | 1/15 (6.7%) | 2/15 (13.3%) | 3/15 (20%) |
| Arm 1 (Extension of Follow-up) | 0/29 (0%) | 2/29 (6.9%) | 1/29 (3.4%) |
| Event | Arm 1 | Arm 2 | Arm C | Arm 1 (Extension of Follow-up) |
|---|---|---|---|---|
| Disseminated tuberculosisInfections and infestations | 0/58 | 0/31 | 1/15 | 0/29 |
| Alanine aminotransferase increasedInvestigations | 1/58 | 0/31 | 1/15 | 0/29 |
| Aspartate aminotransferase increasedInvestigations | 1/58 | 0/31 | 1/15 | 0/29 |
| Bilirubin conjugated increasedInvestigations | 0/58 | 0/31 | 1/15 | 0/29 |
| Small intestinal obstructionGastrointestinal disorders | 0/58 | 0/31 | 0/15 | 1/29 |
| Blood bilirubin increasedInvestigations | 2/58 | 0/31 | 0/15 | 0/29 |
| Diabetes mellitus inadequate controlMetabolism and nutrition disorders | 0/58 | 0/31 | 0/15 | 1/29 |
| Cerebral toxoplasmosisInfections and infestations | 0/58 | 1/31 | 0/15 | 0/29 |
| Immune reconstitution inflammatory syndrome associated tuberculosisInfections and infestations | 0/58 | 1/31 | 0/15 | 0/29 |
| Gun shot woundInjury, poisoning and procedural complications | 0/58 | 1/31 | 0/15 | 0/29 |
| Event | Arm 1 | Arm 2 | Arm C | Arm 1 (Extension of Follow-up) |
|---|---|---|---|---|
| Blood creatinine increasedInvestigations | 14/58 | 3/31 | 0/15 | 0/29 |
| Aspartate aminotransferase increasedInvestigations | 4/58 | 1/31 | 1/15 | 0/29 |
| Chest painGeneral disorders | 0/58 | 0/31 | 1/15 | 0/29 |
| Alanine aminotransferase increasedInvestigations | 1/58 | 0/31 | 1/15 | 0/29 |
| Bilirubin conjugated increasedInvestigations | 0/58 | 0/31 | 1/15 | 0/29 |
| Abnormal loss of weightMetabolism and nutrition disorders | 1/58 | 0/31 | 1/15 | 0/29 |
| HypertensionVascular disorders | 0/58 | 0/31 | 1/15 | 0/29 |
| AnaemiaBlood and lymphatic system disorders | 2/58 | 0/31 | 0/15 | 0/29 |
| Blood glucose increasedInvestigations | 1/58 | 0/31 | 0/15 | 1/29 |
| Pulmonary tuberculosisInfections and infestations | 0/58 | 1/31 | 0/15 | 0/29 |
| Age, Continuous(years) | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup | Total |
|---|---|---|---|---|
| Median | 33 (27 to 39) | 30 (24 to 38) | 35 (31 to 43) | 33 (27 to 39) |
| Sex: Female, Male(Participants) | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup | Total |
|---|---|---|---|---|
| Female | 11 | 9 | 2 | 22 |
| Male | 47 | 22 | 13 | 82 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 49 | 26 | 15 | 90 |
| Unknown or Not Reported | 9 | 5 | 0 | 14 |
| Race/Ethnicity, Customized(Participants) | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup | Total |
|---|---|---|---|---|
| ASIAN | 9 | 6 | 0 | 15 |
| BLACK OR AFRICAN AMERICAN | 49 | 25 | 15 | 89 |
| Region of Enrollment(participants) | Arm 1: Experimental | Arm 2: Standard of Care | Arm C: PK Only Subgroup | Total |
|---|---|---|---|---|
| Haiti | 2 | 2 | 0 | 4 |
| India | 9 | 5 | 0 | 14 |
| Malawi | 26 | 11 | 9 | 46 |
| South Africa | 11 | 6 | 3 | 20 |
| Zimbabwe | 10 | 7 | 3 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG. For what types of analyses? To achieve aims in the proposal approved by the ACTG Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.
Ran from Nov 2021 to primary completion in Jun 2024, 31 months.
Results were first posted in Aug 2025, 1 year 2 months after primary completion.
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Studies of the drugs tested here: Rifapentine · Clofazimine
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