A Phase 2 interventional study of Linezolid 600 mg and Linezolid 1200 mg (QD) in Tuberculosis, Multidrug-Resistant, Tuberculosis and Tuberculosis, Pulmonary, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two doses of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). This study also measured the level of LZD and BDQ in the participants' blood.
When the study was designed, there was currently no "standard of care" or single standardized treatment regimen recommended for everyone with drug resistant-tuberculosis (DR-TB). Current DR-TB treatments were not well tolerated and often had side effects. There was a need to identify drugs with enough anti-TB activity (treatment against TB) and good safety profiles that could improve outcomes in the treatment of DR-TB.
The main purpose of this study was to evaluate the efficacy and tolerability of a new shorter course anti-TB treatment regimen that compared two dosing strategies of linezolid (LZD), combined with bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ). As a secondary aim, the study assessed the safety (the level and type of side effects from a drug or treatment) of the combination of these drugs.
Everyone in the study took BDQ, DLM, and CFZ once a day for the entire treatment period. The difference between the two treatment groups in the study was in how participants took the fourth drug: LZD. Participants in group A took one dose of LZD once a day for the entire treatment period. Participants in group B took a higher dose of LZD once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's enrollment of 138 is below the median of 194 across 88 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant 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.
Females of reproductive potential who are participating in sexual activity that could lead to pregnancy must agree to use two of the following forms of while receiving TB study medications 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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm A participants took linezolid (LZD) once a day for the entire treatment period. * Weeks 1-26: LZD 600 mg once daily (QD) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Drug: Linezolid 600 mg · Drug: Bedaquiline 200 mg · Drug: Bedaquiline 100 mg · Drug: Delamanid 300 mg · Drug: Clofazimine 300 mg · Drug: Clofazimine 100 mg
Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm B participants took a higher dose of linezolid (LZD) once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period. * Weeks 1-4: LZD 1200 mg once daily (QD) * Weeks 5-26: LZD 1200 mg three times per week (TIW) * Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD * Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD * Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Drug: Linezolid 1200 mg (QD) · Drug: Linezolid 1200 mg (TIW) · Drug: Bedaquiline 200 mg · Drug: Bedaquiline 100 mg · Drug: Delamanid 300 mg · Drug: Clofazimine 300 mg · Drug: Clofazimine 100 mg
One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26
Also known as: LZD
Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
Also known as: LZD
Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
Also known as: LZD
Two 100mg tablets taken orally once daily in the morning during weeks 1-8
Also known as: BDQ
One 100mg tablet taken orally once daily in the morning during weeks 9-26
Also known as: BDQ
Six 50mg tablets taken orally once daily in the morning during weeks 1-26
Also known as: DLM
Three 100mg capsules taken orally once daily in the morning during weeks 1-2
Also known as: CFZ
One 100mg capsule taken orally once daily in the morning during weeks 3-26
Also known as: CFZ
Time to 26 Weeks Stable Culture Conversion in Liquid Media
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If the 1st MTB-neg liquid culture was at week 26, then conversion was met. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions at week 26 and the Cox proportional hazards regression model hazard ratio were calculated; between-arm differences were tested with the log rank test.
Time frame: Up to 26 weeks
Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death
Time of permanent discontinuation of at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request by week 26, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: Up to 26 weeks
Proportion of Participants Achieving Stable Liquid Culture Conversion
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 8, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 8 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 8
Proportion of Participants Achieving Stable Liquid Culture Conversion
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 16, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 16 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 16
Proportion of Participants Achieving Stable Liquid Culture Conversion
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 26
Proportion of Participants Achieving Stable Liquid Culture Conversion
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 38, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 38 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 38
Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death
Time of permanent discontinuation of LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: Up to 26 weeks
Proportion of Participants With Temporary Discontinuation of LZD For Any Reason
Time of temporary discontinuation of LZD for any reason was the corresponding date of first temporary discontinuation. If a participant did not temporarily discontinue LZD by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with temporary discontinuation of LZD were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: Up to 26 weeks
Proportion of Participants With LZD Dose Reduction
Time of LZD dose reduction was the corresponding date of the first LZD dose reduction. If a participant did not undergo a LZD dose reduction by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with LZD dose reduction were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: Up to 26 weeks
Proportion of Participants With Treatment-Related Adverse Events
Time of treatment-related adverse event was the corresponding date of the adverse event. If a participant did not experience a treatment-related adverse event, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with treatment-related adverse event were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: Up to 26 weeks
Proportion of Participants With Unfavorable TB Treatment Outcome
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 26, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 26
Proportion of Participants With Unfavorable TB Treatment Outcome
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 38, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 38
Proportion of Participants With Unfavorable TB Treatment Outcome
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 72, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Time frame: At week 72
Pharmacokinetic Parameter for Linezolid: Minimum Plasma Concentration (Cmin)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Linezolid: Maximum Plasma Concentration (Cmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Linezolid: Time to Reach Maximum Plasma Concentration (Tmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Linezolid: Area Under the Concentration-time Curve (AUC)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
Time frame: At week 4
Pharmacokinetic Parameter for Linezolid: Apparent Oral Clearance (CL/F)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid: Minimum Plasma Concentration (Cmin)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid: Maximum Plasma Concentration (Cmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid: Time to Reach Maximum Plasma Concentration (Tmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid: Area Under the Concentration-time Curve (AUC)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid: Apparent Oral Clearance (CL/F)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Minimum Plasma Concentration (Cmin)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Maximum Plasma Concentration (Cmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Time to Reach Maximum Plasma Concentration (Tmax)
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Area Under the Concentration-time Curve (AUC)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
Time frame: At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Apparent Oral Clearance (CL/F)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
Time frame: At week 4
Number of Participants With >90% Directly Observed Therapy Doses Taken During the Treatment Period
At each visit, the site reported the number of directly observed therapy (DOT) doses since the last visit. The number of expected DOT doses was 182. The number of expected DOT doses was adjusted by removing the number of days during temporary holds due to adverse events. This avoided penalizing participants who missed DOT doses due to protocol-required treatment holds for adverse events. Participants who missed DOT doses for other reasons were penalized even if they made up the missed doses by the week 30 study visit as allowed by the protocol. The proportion of expected 182 DOT doses was calculated as the total number of DOT doses reported by the site divided by the adjusted number of expected DOT doses.
Time frame: Up to 26 weeks
Participants were enrolled from 27 September 2022 to 04 September 2024 in 13 sites located in South Africa (5 sites), Haiti (2 sites), Thailand (2 sites), Botswana, Brazil, Peru, and Philippines.
| Milestone | Arm A | Arm B |
|---|---|---|
| Started | 69 | 69 |
| Completed | 60 | 59 |
| Not completed | 9 | 10 |
| Withdrew: Death | 0 | 4 |
| Withdrew: Lost to follow-up | 6 | 4 |
| Withdrew: Protocol violation | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If the 1st MTB-neg liquid culture was at week 26, then conversion was met. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions at week 26 and the Cox proportional hazards regression model hazard ratio were calculated; between-arm differences were tested with the log rank test.
| Weeks | Arm A | Arm B |
|---|---|---|
| Time to 26 Weeks Stable Culture Conversion in Liquid Media | 8 (6 to 12) | 12 (6 to 16) |
Time of permanent discontinuation of at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request by week 26, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death | 0.153 (0.086 to 0.266) | 0.152 (0.085 to 0.264) |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 8, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 8 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 0.607 (0.487 to 0.728) | 0.488 (0.365 to 0.626) |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 16, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 16 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 0.962 (0.886 to 0.993) | 0.903 (0.807 to 0.964) |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 0.967 (0.899 to 0.994) | 0.917 (0.823 to 0.972) |
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 38, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 38 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants Achieving Stable Liquid Culture Conversion | 0.934 (0.854 to 0.979) | 0.946 (0.866 to 0.986) |
Time of permanent discontinuation of LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death | 0.108 (0.053 to 0.213) | 0.136 (0.073 to 0.245) |
Time of temporary discontinuation of LZD for any reason was the corresponding date of first temporary discontinuation. If a participant did not temporarily discontinue LZD by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with temporary discontinuation of LZD were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Temporary Discontinuation of LZD For Any Reason | 0.32 (0.22 to 0.45) | 0.29 (0.20 to 0.42) |
Time of LZD dose reduction was the corresponding date of the first LZD dose reduction. If a participant did not undergo a LZD dose reduction by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with LZD dose reduction were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With LZD Dose Reduction | 0.28 (0.19 to 0.41) | 0.30 (0.21 to 0.43) |
Time of treatment-related adverse event was the corresponding date of the adverse event. If a participant did not experience a treatment-related adverse event, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with treatment-related adverse event were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Treatment-Related Adverse Events | 0.68 (0.56 to 0.78) | 0.68 (0.57 to 0.79) |
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 26, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Unfavorable TB Treatment Outcome | 0.10 (0.04 to 0.20) | 0.16 (0.08 to 0.28) |
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 38, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Unfavorable TB Treatment Outcome | 0.15 (0.08 to 0.28) | 0.22 (0.12 to 0.37) |
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 72, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
| proportion of participants | Arm A | Arm B |
|---|---|---|
| Proportion of Participants With Unfavorable TB Treatment Outcome | 0.13 (0.07 to 0.24) | 0.20 (0.12 to 0.33) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Linezolid: Minimum Plasma Concentration (Cmin) | 1855 (1104 to 2365) | 4170 (3070 to 8360) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Linezolid: Maximum Plasma Concentration (Cmax) | 14200 (11500 to 17100) | 31550 (26650 to 36350) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| hours | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Linezolid: Time to Reach Maximum Plasma Concentration (Tmax) | 4 (2 to 4.01) | 2.93 (1.5 to 4) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
| hours*ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Linezolid: Area Under the Concentration-time Curve (AUC) | 167028 (128180 to 187298) | 370726 (292156 to 460426) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
| mL/h | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Linezolid: Apparent Oral Clearance (CL/F) | 3592 (3204 to 4682) | 3237 (2608 to 4109) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid: Minimum Plasma Concentration (Cmin) | 201 (137 to 225) | 140 (97.4 to 202) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid: Maximum Plasma Concentration (Cmax) | 475 (401 to 502) | 416 (271 to 494) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| hours | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid: Time to Reach Maximum Plasma Concentration (Tmax) | 4.03 (4 to 8) | 4 (3 to 4) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
| hours*ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid: Area Under the Concentration-time Curve (AUC) | 7263 (6107 to 8295) | 6204 (4280 to 7643) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
| mL/h | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid: Apparent Oral Clearance (CL/F) | 41314 (36176 to 49135) | 48611 (39255 to 70088) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Minimum Plasma Concentration (Cmin) | 95 (75.5 to 114) | 73.8 (56.2 to 117) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Maximum Plasma Concentration (Cmax) | 130 (103 to 161) | 125 (89.1 to 157) |
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
| hours | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Time to Reach Maximum Plasma Concentration (Tmax) | 4.06 (3 to 8) | 7.90 (3 to 8) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
| hours*ng/mL | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Area Under the Concentration-time Curve (AUC) | 2747 (2146 to 3195) | 2546 (1833 to 3217) |
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
| mL/h | Arm A | Arm B |
|---|---|---|
| Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Apparent Oral Clearance (CL/F) | 109223 (94181 to 139826) | 117827 (93270 to 163670) |
At each visit, the site reported the number of directly observed therapy (DOT) doses since the last visit. The number of expected DOT doses was 182. The number of expected DOT doses was adjusted by removing the number of days during temporary holds due to adverse events. This avoided penalizing participants who missed DOT doses due to protocol-required treatment holds for adverse events. Participants who missed DOT doses for other reasons were penalized even if they made up the missed doses by the week 30 study visit as allowed by the protocol. The proportion of expected 182 DOT doses was calculated as the total number of DOT doses reported by the site divided by the adjusted number of expected DOT doses.
| Participants | Arm A | Arm B |
|---|---|---|
| Number of Participants With >90% Directly Observed Therapy Doses Taken During the Treatment Period | 34 | 27 |
Collected over From entry through Week 72. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | 0/69 (0%) | 14/69 (20.3%) | 52/69 (75.4%) |
| Arm B | 4/69 (5.8%) | 19/69 (27.5%) | 57/69 (82.6%) |
| Event | Arm A | Arm B |
|---|---|---|
| Electrocardiogram QT prolongedInvestigations | 2/69 | 4/69 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/69 | 3/69 |
| PneumoniaInfections and infestations | 0/69 | 2/69 |
| AnaemiaBlood and lymphatic system disorders | 1/69 | 1/69 |
| Normochromic anaemiaBlood and lymphatic system disorders | 0/69 | 1/69 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/69 | 1/69 |
| Cor pulmonaleCardiac disorders | 1/69 | 0/69 |
| Pericardial effusionCardiac disorders | 0/69 | 1/69 |
| Abdominal pain lowerGastrointestinal disorders | 1/69 | 0/69 |
| Alcoholic pancreatitisGastrointestinal disorders | 1/69 | 0/69 |
| Event | Arm A | Arm B |
|---|---|---|
| Electrocardiogram QT prolongedInvestigations | 20/69 | 29/69 |
| Creatinine renal clearance decreasedInvestigations | 20/69 | 16/69 |
| Haemoglobin decreasedInvestigations | 13/69 | 16/69 |
| Alanine aminotransferase increasedInvestigations | 13/69 | 8/69 |
| Neuropathy peripheralNervous system disorders | 13/69 | 6/69 |
| AnaemiaBlood and lymphatic system disorders | 3/69 | 8/69 |
| Aspartate aminotransferase increasedInvestigations | 7/69 | 3/69 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/69 | 5/69 |
| Bilirubin conjugated increasedInvestigations | 4/69 | 1/69 |
| Blood lactic acid increasedInvestigations | 3/69 | 4/69 |
| Age, Continuous(years) | Arm A | Arm B | Total |
|---|---|---|---|
| Mean | 35 ± 12 | 37 ± 14 | 36 ± 13 |
| Age, Customized(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Age category — 18 - <30 | 28 | 26 | 54 |
| Age category — 30 - < 60 | 39 | 37 | 76 |
| Age category — >= 60 | 2 | 6 | 8 |
| Sex: Female, Male(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Female | 25 | 26 | 51 |
| Male | 44 | 43 | 87 |
| Race (NIH/OMB)(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 20 | 18 | 38 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 41 | 42 | 83 |
| White | 0 | 1 | 1 |
| More than one race | 8 | 8 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Haiti | 5 | 4 | 9 |
| Botswana | 2 | 1 | 3 |
| Philippines | 15 | 12 | 27 |
| Brazil | 4 | 6 | 10 |
| South Africa | 33 | 35 | 68 |
| Thailand | 5 | 6 | 11 |
| Peru | 5 | 5 | 10 |
| MTB Culture Result(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| MTB-Negative | 3 | 11 | 14 |
| MTB-Positive | 65 | 58 | 123 |
| Indeterminate | 1 | 0 | 1 |
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 ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections). For what types of analyses? To achieve aims in the proposal approved by the ACTG. 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://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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