ClinicalTrials.gg
Sign In
CompletedNCT02563327S31PK/PDUpdated Aug 27, 2026Results posted

Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis

A Phase 3 interventional study of Rifapentine and Moxifloxacin in Tuberculosis, sponsored by Centers for Disease Control and Prevention. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Centers for Disease Control and Prevention · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,516
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The Tuberculosis Trials Consortium (TBTC) Study 31 is a phase 3 trial evaluating rifapentine-containing regimens for treatment-shortening of drug-susceptible pulmonary tuberculosis. This pharmacokinetic/pharmacodynamic (PK/PD) substudy evaluates rifapentine and moxifloxacin exposure-response relationships for efficacy and safety outcomes. Intensive and sparse PK sampling are performed among participants receiving rifapentine-containing regimens. PK and clinical outcomes data are used to characterize population pharmacokinetics and assess relationships between drug exposure, culture conversion, treatment failure or relapse, and adverse events.

Read the detailed description

This pharmacokinetic/pharmacodynamic (PK/PD) substudy is conducted within TBTC Study 31, a phase 3 randomized trial evaluating rifapentine-containing regimens for treatment-shortening of drug-susceptible pulmonary tuberculosis.

The substudy evaluates population pharmacokinetics and exposure-response relationships for rifapentine and moxifloxacin administered in rifapentine-containing multidrug regimens. Rifapentine is administered at a daily dose of 1200 mg with food, with or without moxifloxacin.

Participants undergo intensive and sparse pharmacokinetic sampling between Weeks 2 and 8 of treatment. Intensive PK sampling includes serial plasma collections over approximately 24 hours in a subset of participants, with additional later sampling performed after at least 14 days. Sparse PK sampling is performed in the remaining Study 31 participants.

Population PK models are developed using nonlinear mixed-effects methods to estimate individual exposure parameters including area under the concentration-time curve (AUC0-24) and maximum concentration (Cmax). PK/PD analyses evaluate relationships between drug exposure and efficacy outcomes, including culture conversion and treatment failure or relapse, as well as safety outcomes including grade 3 or higher adverse events.

The study also evaluates the effect of covariates including demographic and clinical factors on rifapentine and moxifloxacin pharmacokinetics.

02

Conditions studied

  • Tuberculosis

Browse trials for

Keywords

  • Pharmacokinetics
03

In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 2,516 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Browse Centers for Disease Control and Prevention studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Age 18 years or greater
  • Enrolled in TBTC Study 31
  • Randomized to receive one of the rifapentine treatment regimens.
  • Willingness to be sampled 6 times during 1 PK sampling session and 2 - 3 times during another PK sampling session at an outpatient clinic, a clinical research center, or a hospital.
  • Written given for the Study 31 PK/PD study

Exclusion criteria

Exclusion Criteria:

  • Hematocrit \< 25% most recent value, measured within 30 days before PK/PD study enrollment
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,516 participants (actual)

Study arms

  • Active comparator
    Standard Therapy

    Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, \< 55kg 1000 mg, \>= 55-75 kg 1500 mg, \>75 kg 2000 mg; ethambutol, \< 55kg 800 mg, \>= 55-75 kg 1200 mg, \>75 kg 1600 mg.

    Drug: Rifampin · Drug: Isoniazid · Drug: Pyrazinamide · Drug: Ethambutol · Dietary Supplement: Pyridoxine

  • Experimental
    Rifapentine-containing Regimen

    Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, \< 55kg 1000 mg, \>= 55-75 kg 1500 mg, \>75 kg 2000 mg; ethambutol, \< 55kg 800 mg, \>= 55-75 kg 1200 mg, \>75 kg 1600 mg.

    Drug: Rifapentine · Drug: Isoniazid · Drug: Pyrazinamide · Drug: Ethambutol · Dietary Supplement: Pyridoxine

  • Experimental
    Rifapentine- and Moxifloxacin-containing Regimen

    Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose. Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, \< 55kg 1000 mg, \>= 55-75 kg 1500 mg, \>75 kg 2000 mg; moxifloxacin, 400 mg.

    Drug: Rifapentine · Drug: Moxifloxacin · Drug: Isoniazid · Drug: Pyrazinamide · Dietary Supplement: Pyridoxine

Interventions

  • DrugRifapentine

    A rifamycin with activity against Mycobacterium tuberculosis

    Also known as: Priftin

  • DrugMoxifloxacin

    A fluoroquinolone

  • DrugRifampin

    A rifamycin with activity against Mycobacterium tuberculosis

  • DrugIsoniazid

    An anti-tuberculosis agent

  • DrugPyrazinamide

    An anti-tuberculosis agent

  • DrugEthambutol

    An anti-tuberculosis agent

  • Dietary supplementPyridoxine

    An essential vitamin

    Also known as: Vitamin B6

06

What researchers measure

Primary outcomes

  1. Rifapentine Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24)

    To characterize rifapentine exposure (AUC0-24) using population pharmacokinetics.

    Time frame: Plasma concentrations measured at approximately 0.5, 3, 5, 9, 12, and 24 hours after the pharmacokinetic reference dose during Weeks 2-8 after treatment initiation.

  2. Rifapentine Maximum Plasma Concentration (Cmax)

    To characterize rifapentine peak concentration using population pharmacokinetic modeling.

    Time frame: Plasma concentrations measured during 0-24 hours following the pharmacokinetic reference dose; PK sampling performed during Weeks 2-8 after treatment initiation.

Secondary outcomes

  1. Number of Participants With TB-Related Unfavorable Outcomes in the Rifapentine-Moxifloxacin Regimen

    Number of microbiologically eligible participants with TB-related unfavorable outcomes in the rifapentine-moxifloxacin regimen through 12 months after treatment initiation. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.

    Time frame: Efficacy assessed through 12 months after treatment initiation; pharmacokinetics assessed during Weeks 2-8.

  2. Number of Participants With Grade 3 or Higher Adverse Events

    Number of participants with grade 3 or higher adverse events during the treatment period in each rifapentine-containing treatment arm. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.

    Time frame: Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.

  3. Moxifloxacin Area Under the Concentration-Time Curve at Steady State

    To characterize moxifloxacin pharmacokinetics when moxifloxacin was administered 400 mg daily with rifapentine 1200 mg daily.

    Time frame: Weeks 2 through 8 after treatment initiation.

  4. Number of Participants With Grade 3 or Higher Adverse Events in the Rifapentine-Moxifloxacin Regimen

    Number of participants with grade 3 or higher adverse events in the rifapentine-moxifloxacin regimen during the treatment period. The association between moxifloxacin exposure and safety outcomes was evaluated using multivariable logistic regression and is reported in the Statistical Analysis section.

    Time frame: Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.

07

Results

Posted Aug 27, 2026

Participant flow

Participants were enrolled at 34 clinical research sites in 13 countries between January 2016 and October 2018. First participant was enrolled on 25 January 2016. Last participant was enrolled on 30 October 2018

Participant flow — Overall Study
MilestoneRegimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)
Started829838849
Microbiologically eligible analysis population768784791
Assessable analysis population726752756
Completed661702689
Not completed168136160
Withdrew: Death733
Withdrew: Lost to follow-up822
Withdrew: Pregnancy845
Withdrew: Baseline drug resistance494051
Withdrew: No baseline positive m. tuberculosis culture463
Withdrew: Adverse event8916
Withdrew: Consent withdrawn no ae reported141115
Withdrew: Consent withdrawn after occurrence of ae233
Withdrew: Treatment changed for other reasons744
Withdrew: Baseline drug resistance494051
Withdrew: No baseline positive culture463
Withdrew: Protocol violation884

Outcome measures

PrimaryRifapentine Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24)

To characterize rifapentine exposure (AUC0-24) using population pharmacokinetics.

Time frame:
Plasma concentrations measured at approximately 0.5, 3, 5, 9, 12, and 24 hours after the pharmacokinetic reference dose during Weeks 2-8 after treatment initiation.
Reported as:
Median · µg*h/mL
Rifapentine Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24)
µg*h/mLRegimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)
Rifapentine Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24)562.4 (302 to 1037)557.1 (276 to 983)
PrimaryRifapentine Maximum Plasma Concentration (Cmax)

To characterize rifapentine peak concentration using population pharmacokinetic modeling.

Time frame:
Plasma concentrations measured during 0-24 hours following the pharmacokinetic reference dose; PK sampling performed during Weeks 2-8 after treatment initiation.
Reported as:
Median · µg/mL
Rifapentine Maximum Plasma Concentration (Cmax)
µg/mLRegimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM
Rifapentine Maximum Plasma Concentration (Cmax)32.4 (19.5 to 53.4)32.8 (19.2 to 51.9)
SecondaryNumber of Participants With TB-Related Unfavorable Outcomes in the Rifapentine-Moxifloxacin Regimen

Number of microbiologically eligible participants with TB-related unfavorable outcomes in the rifapentine-moxifloxacin regimen through 12 months after treatment initiation. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.

Time frame:
Efficacy assessed through 12 months after treatment initiation; pharmacokinetics assessed during Weeks 2-8.
Reported as:
Count of participants · Participants
Number of Participants With TB-Related Unfavorable Outcomes in the Rifapentine-Moxifloxacin Regimen
ParticipantsRegimen 3 (2HPZM/2HPM)
Number of Participants With TB-Related Unfavorable Outcomes in the Rifapentine-Moxifloxacin Regimen45
Statistical analysis
  • Regimen 3 (2HPZM/2HPM) · Hazard ratio (hr): 0.65 · 95% CI 0.54 to 0.77Hazard ratio per 100 µg\*h/mL increase in rifapentine AUC0-24. The complete-case multivariable model included 688 participants.
  • Regimen 3 (2HPZM/2HPM) · Hazard ratio (hr): 0.92 · 95% CI 0.70 to 1.20Hazard ratio per 5 mg\*h/L increase in moxifloxacin AUC at steady state. The moxifloxacin efficacy analysis included 732 participants.
SecondaryNumber of Participants With Grade 3 or Higher Adverse Events

Number of participants with grade 3 or higher adverse events during the treatment period in each rifapentine-containing treatment arm. Associations with rifapentine and moxifloxacin exposures are reported in separate Statistical Analyses.

Time frame:
Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.
Reported as:
Number · participants
Number of Participants With Grade 3 or Higher Adverse Events
participantsRegimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)
Number of Participants With Grade 3 or Higher Adverse Events119159
Statistical analysis
  • Regimen 2 (2HPZ/2HP) vs Regimen 3 (2HPZM/2HPM) · Odds ratio (or): 1.02 · 95% CI 0.94 to 1.10Odds ratio for Grade 3 or higher adverse event per 100 µg\*h/mL increase in rifapentine AUC0-24 among participants receiving rifapentine-containing regimens.
  • Regimen 3 (2HPZM/2HPM) · Odds ratio (or): 0.99 · 95% CI 0.86 to 1.15Odds ratio for grade 3 or higher adverse events per 5 mg\*h/L increase in moxifloxacin AUC0-24 in Regimen 3. The exposure-response analysis included 774 participants with available moxifloxacin PK data.
SecondaryMoxifloxacin Area Under the Concentration-Time Curve at Steady State

To characterize moxifloxacin pharmacokinetics when moxifloxacin was administered 400 mg daily with rifapentine 1200 mg daily.

Time frame:
Weeks 2 through 8 after treatment initiation.
Reported as:
Median · µg*h/mL
Moxifloxacin Area Under the Concentration-Time Curve at Steady State
µg*h/mLRegimen 3 (2HPZM/2HPM)
Moxifloxacin Area Under the Concentration-Time Curve at Steady State24.3 (15.2 to 45.4)
SecondaryNumber of Participants With Grade 3 or Higher Adverse Events in the Rifapentine-Moxifloxacin Regimen

Number of participants with grade 3 or higher adverse events in the rifapentine-moxifloxacin regimen during the treatment period. The association between moxifloxacin exposure and safety outcomes was evaluated using multivariable logistic regression and is reported in the Statistical Analysis section.

Time frame:
Pharmacokinetics assessed Weeks 2-8; Safety assessed from randomization through treatment period, up to 14 days after last dose.
Reported as:
Number · participants
Number of Participants With Grade 3 or Higher Adverse Events in the Rifapentine-Moxifloxacin Regimen
participantsRegimen 3 (2HPZM/2HPM)
Number of Participants With Grade 3 or Higher Adverse Events in the Rifapentine-Moxifloxacin Regimen159
Statistical analysis
  • Regimen 3 (2HPZM/2HPM) · Odds ratio (or): 0.99 · 95% CI 0.86 to 1.15Odds ratio for Grade 3 or higher adverse event per 5 mg\*h/L increase in moxifloxacin exposure among participants receiving the rifapentine-moxifloxacin regimen.

Adverse events

Collected over From randomization to up to 14 days after last dose of study treatment (4 months or 6 months plus up to 14 days). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Regimen 1 (2HRZE/4HR)7/825 (0.8%)56/825 (6.8%)74/825 (9%)
Regimen 2 (2HPZ/2HP)4/835 (0.5%)39/835 (4.7%)61/835 (7.3%)
Regimen 3 (2HPZM/2HPM)3/846 (0.4%)37/846 (4.4%)94/846 (11.1%)
Most frequent serious events
Showing 10 of 77
Most frequent serious events
EventRegimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)
HEPATITISHepatobiliary disorders10/8255/8357/846
HAEMOPTYSISRespiratory, thoracic and mediastinal disorders5/8254/8351/846
NEUTROPENIABlood and lymphatic system disorders3/8251/8352/846
DEEP VEIN THROMBOSISVascular disorders3/8252/8351/846
PREGNANCYPregnancy, puerperium and perinatal conditions2/8253/8352/846
PNEUMONIAInfections and infestations1/8251/8353/846
URTICARIASkin and subcutaneous tissue disorders0/8251/8353/846
PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders2/8251/8350/846
STAB WOUNDInjury, poisoning and procedural complications1/8252/8350/846
DIABETIC RETINOPATHYEye disorders1/8250/8350/846
Most frequent other events
Most frequent other events
EventRegimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)
NEUTROPENIABlood and lymphatic system disorders48/82534/83556/846
HepatitisHepatobiliary disorders26/82527/83538/846

Baseline characteristics

Microbiologically eligible analysis population

Age, Categorical
Age, Categorical(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
<=18 years19192563
Between 18 and 65 years7437557552253
>=65 years6101127
Age, Continuous
Age, Continuous(years)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
Median30.9 (24.9 to 41.0)31 (24.6 to 41.2)31 (24.6 to 41.5)31 (24.6 to 41.3)
Sex: Female, Male
Sex: Female, Male(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
Female224221228673
Male5445635631670
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
Hispanic or Latino27202774
Not Hispanic or Latino287283297867
Unknown or Not Reported4544814671402
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
American Indian or Alaska Native0000
Asian869389268
Native Hawaiian or Other Pacific Islander0000
Black or African American5535715521676
White1581336
More than one race111111135357
Unknown or Not Reported3126
Region of Enrollment
Region of Enrollment(participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
Africa5655735781716
East Asia868988263
South America109115115339
United States871025
HIV status at baseline
HIV status at baseline(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
HIV Negative7047167292149
HIV Positive646862194
Cavitation status at baseline
Cavitation status at baseline(Participants)Regimen 1 (2HRZE/4HR)Regimen 2 (2HPZ/2HP)Regimen 3 (2HPZM/2HPM)Total
Cavitation on chest radiograph5585735721703
No cavitation on chest radiograph204205210619
Unknown66921
08

Study locations

3 sites
  • University of Texas Health Science Center at
    San Antonio, Texas 78229, United States
  • Joint Clinical Research Centre/ Makerere Univ Med Sch
    Kampala, Uganda
  • National TB Program
    Hanoi, Vietnam
09

References and documents

Publications

  • Ballow C, Lettieri J, Agarwal V, Liu P, Stass H, Sullivan JT. Absolute bioavailability of moxifloxacin. Clin Ther. 1999 Mar;21(3):513-22. doi: 10.1016/S0149-2918(00)88306-X. PubMed 10321420 ↗
  • Burman WJ, Gallicano K, Peloquin C. Comparative pharmacokinetics and pharmacodynamics of the rifamycin antibacterials. Clin Pharmacokinet. 2001;40(5):327-41. doi: 10.2165/00003088-200140050-00002. PubMed 11432536 ↗
  • Conde MB, Efron A, Loredo C, De Souza GR, Graca NP, Cezar MC, Ram M, Chaudhary MA, Bishai WR, Kritski AL, Chaisson RE. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet. 2009 Apr 4;373(9670):1183-9. doi: 10.1016/S0140-6736(09)60333-0. PubMed 19345831 ↗
  • Dooley K, Flexner C, Hackman J, Peloquin CA, Nuermberger E, Chaisson RE, Dorman SE. Repeated administration of high-dose intermittent rifapentine reduces rifapentine and moxifloxacin plasma concentrations. Antimicrob Agents Chemother. 2008 Nov;52(11):4037-42. doi: 10.1128/AAC.00554-08. Epub 2008 Sep 2. PubMed 18765687 ↗
  • Dooley KE, Bliven-Sizemore EE, Weiner M, Lu Y, Nuermberger EL, Hubbard WC, Fuchs EJ, Melia MT, Burman WJ, Dorman SE. Safety and pharmacokinetics of escalating daily doses of the antituberculosis drug rifapentine in healthy volunteers. Clin Pharmacol Ther. 2012 May;91(5):881-8. doi: 10.1038/clpt.2011.323. PubMed 22472995 ↗
  • Dorman SE, Goldberg S, Stout JE, Muzanyi G, Johnson JL, Weiner M, Bozeman L, Heilig CM, Feng PJ, Moro R, Narita M, Nahid P, Ray S, Bates E, Haile B, Nuermberger EL, Vernon A, Schluger NW; Tuberculosis Trials Consortium. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis. 2012 Oct 1;206(7):1030-40. doi: 10.1093/infdis/jis461. Epub 2012 Jul 30. PubMed 22850121 ↗
  • Dorman SE, Savic RM, Goldberg S, Stout JE, Schluger N, Muzanyi G, Johnson JL, Nahid P, Hecker EJ, Heilig CM, Bozeman L, Feng PJ, Moro RN, MacKenzie W, Dooley KE, Nuermberger EL, Vernon A, Weiner M; Tuberculosis Trials Consortium. Daily rifapentine for treatment of pulmonary tuberculosis. A randomized, dose-ranging trial. Am J Respir Crit Care Med. 2015 Feb 1;191(3):333-43. doi: 10.1164/rccm.201410-1843OC. PubMed 25489785 ↗
  • Horne DJ, Royce SE, Gooze L, Narita M, Hopewell PC, Nahid P, Steingart KR. Sputum monitoring during tuberculosis treatment for predicting outcome: systematic review and meta-analysis. Lancet Infect Dis. 2010 Jun;10(6):387-94. doi: 10.1016/S1473-3099(10)70071-2. PubMed 20510279 ↗
  • Keung AC, Eller MG, Weir SJ. Single-dose pharmacokinetics of rifapentine in women. J Pharmacokinet Biopharm. 1998 Feb;26(1):75-85. doi: 10.1023/a:1023276808298. PubMed 9773393 ↗
  • Lettieri J, Vargas R, Agarwal V, Liu P. Effect of food on the pharmacokinetics of a single oral dose of moxifloxacin 400mg in healthy male volunteers. Clin Pharmacokinet. 2001;40 Suppl 1:19-25. doi: 10.2165/00003088-200140001-00003. PubMed 11352438 ↗
  • Nijland HM, Ruslami R, Suroto AJ, Burger DM, Alisjahbana B, van Crevel R, Aarnoutse RE. Rifampicin reduces plasma concentrations of moxifloxacin in patients with tuberculosis. Clin Infect Dis. 2007 Oct 15;45(8):1001-7. doi: 10.1086/521894. Epub 2007 Sep 4. PubMed 17879915 ↗
  • Pranger AD, Kosterink JG, van Altena R, Aarnoutse RE, van der Werf TS, Uges DR, Alffenaar JW. Limited-sampling strategies for therapeutic drug monitoring of moxifloxacin in patients with tuberculosis. Ther Drug Monit. 2011 Jun;33(3):350-4. doi: 10.1097/FTD.0b013e31821b793c. PubMed 21544017 ↗
  • Rustomjee R, Lienhardt C, Kanyok T, Davies GR, Levin J, Mthiyane T, Reddy C, Sturm AW, Sirgel FA, Allen J, Coleman DJ, Fourie B, Mitchison DA; Gatifloxacin for TB (OFLOTUB) study team. A Phase II study of the sterilising activities of ofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2008 Feb;12(2):128-38. PubMed 18230244 ↗
  • Savic RM, Lu Y, Bliven-Sizemore E, Weiner M, Nuermberger E, Burman W, Dorman SE, Dooley KE. Population pharmacokinetics of rifapentine and desacetyl rifapentine in healthy volunteers: nonlinearities in clearance and bioavailability. Antimicrob Agents Chemother. 2014 Jun;58(6):3035-42. doi: 10.1128/AAC.01918-13. Epub 2014 Mar 10. PubMed 24614383 ↗
  • Soman A, Honeybourne D, Andrews J, Jevons G, Wise R. Concentrations of moxifloxacin in serum and pulmonary compartments following a single 400 mg oral dose in patients undergoing fibre-optic bronchoscopy. J Antimicrob Chemother. 1999 Dec;44(6):835-8. doi: 10.1093/jac/44.6.835. PubMed 10590288 ↗
  • Stass H, Dalhoff A, Kubitza D, Schuhly U. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother. 1998 Aug;42(8):2060-5. doi: 10.1128/AAC.42.8.2060. PubMed 9687407 ↗
  • Stass H, Kubitza D. Pharmacokinetics and elimination of moxifloxacin after oral and intravenous administration in man. J Antimicrob Chemother. 1999 May;43 Suppl B:83-90. doi: 10.1093/jac/43.suppl_2.83. PubMed 10382880 ↗
  • Stass H, Kubitza D, Schuhly U. Pharmacokinetics, safety and tolerability of moxifloxacin, a novel 8-methoxyfluoroquinolone, after repeated oral administration. Clin Pharmacokinet. 2001;40 Suppl 1:1-9. doi: 10.2165/00003088-200140001-00001. PubMed 11352436 ↗
  • Stass H, Kubitza D. Effects of dairy products on the oral bioavailability of moxifloxacin, a novel 8-methoxyfluoroquinolone, in healthy volunteers. Clin Pharmacokinet. 2001;40 Suppl 1:33-8. doi: 10.2165/00003088-200140001-00005. PubMed 11352440 ↗
  • Sullivan JT, Woodruff M, Lettieri J, Agarwal V, Krol GJ, Leese PT, Watson S, Heller AH. Pharmacokinetics of a once-daily oral dose of moxifloxacin (Bay 12-8039), a new enantiomerically pure 8-methoxy quinolone. Antimicrob Agents Chemother. 1999 Nov;43(11):2793-7. doi: 10.1128/AAC.43.11.2793. PubMed 10543767 ↗
  • Tam CM, Chan SL, Lam CW, Leung CC, Kam KM, Morris JS, Mitchison DA. Rifapentine and isoniazid in the continuation phase of treating pulmonary tuberculosis. Initial report. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1726-33. doi: 10.1164/ajrccm.157.6.9707037. PubMed 9620898 ↗
  • Weiner M, Bock N, Peloquin CA, Burman WJ, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S; Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med. 2004 Jun 1;169(11):1191-7. doi: 10.1164/rccm.200311-1612OC. Epub 2004 Feb 12. PubMed 14962821 ↗
  • Weiner M, Burman W, Luo CC, Peloquin CA, Engle M, Goldberg S, Agarwal V, Vernon A. Effects of rifampin and multidrug resistance gene polymorphism on concentrations of moxifloxacin. Antimicrob Agents Chemother. 2007 Aug;51(8):2861-6. doi: 10.1128/AAC.01621-06. Epub 2007 May 21. PubMed 17517835 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — De-identified participant data underlying published results may be made available through an approved data sharing platform following publication and sponsor approval.

Time frame: Following publication.

Access criteria: Access may be provided to qualified researchers upon request and approval by the study sponsor and data access committee.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Aug 2021, 67 months.

Results were first posted in Aug 2026, 4 years 11 months after primary completion.

Of 33 non-industry phase 3 interventional studies under Tuberculosis, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 67. This study's 67 months is above that.

Counting every sponsor, half of 40 studies reached it within 55 months; a quarter within 38 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2015
First posted
Sep 30, 2015
StartActual
Jan 25, 2016
Primary completionActual
Aug 30, 2021
CompletionActual
Aug 30, 2021
Results first posted
Aug 27, 2026
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02563327
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Responsible party
Sponsor
First posted
Sep 30, 2015
Start date
Jan 25, 2016
Primary completion
Aug 30, 2021
Completion
Aug 30, 2021
Results posted
Aug 27, 2026
Last update
Aug 27, 2026

Study contacts

Rada Savic, PhD
study chair · University of San Francisco School of Pharmacy, San Francisco, CA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Rifapentine · Moxifloxacin · Ethambutol

Other studies in this condition

Tuberculosis →

Other studies from this sponsor

Centers for Disease Control and Prevention →

Start the discussion