National Institutes of Health: Tuberculosis trials

The registry lists 91 Tuberculosis studies with National Institutes of Health as lead sponsor. 6 are open to participants now and 19 have results posted.

Phase 1 27Phase 2 22Phase 3 9Phase 4 1No phase 38(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Clinical Study of the HCMV-TB Vaccine Candidate VIR-1778 in Healthy AdultsNot yet recruitingNCT07818824Phase 1
• A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)Not yet recruitingNCT07595042Phase 2
• A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIVRecruitingNCT07124559Phase 1/2
• Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous MeningitisRecruitingNCT05383742Phase 2
• Paradoxical Tuberculosis Reactions in Patients Without HIV InfectionRecruitingNCT04052022
• Training Protocol on the Natural History of TuberculosisRecruitingNCT01212003
• Linezolid Dosing Strategies in Drug-Resistant TBCompletedNCT05007821Phase 2Results posted
• Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and PostpartumTerminatedNCT04518228Results posted
• Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST StudyTerminatedNCT04311502Phase 2Results posted
• Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal FunctionCompletedNCT03896750Phase 1Results posted
• A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and RifabutinCompletedNCT03891901Phase 2Results posted
• StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With TuberculosisCompletedNCT03882177Phase 2Results posted
• Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIVCompletedNCT03141060Phase 1/2Results posted
• Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIVCompletedNCT02906007Phase 1/2Results posted
• Using Biomarkers to Predict TB Treatment DurationCompletedNCT02821832Phase 2Results posted
• Evaluating PK, Tolerability, and Safety of Rifapentine and Isoniazid in Pregnant and Postpartum WomenCompletedNCT02651259Phase 1/2Results posted
• Evaluating the Safety, Tolerability, and Pharmacokinetics of Bedaquiline and Delamanid, Alone and in Combination, For Drug-Resistant Pulmonary TuberculosisCompletedNCT02583048Phase 2Results posted
• Pretomanid in Adults With Hepatic ImpairmentTerminatedNCT02422524Phase 1Results posted
• Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TBCompletedNCT01751568Phase 1/2Results posted
• Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant WomenCompletedNCT01494038Phase 4Results posted
• Brief Rifapentine-Isoniazid Evaluation for TB Prevention (BRIEF TB)CompletedNCT01404312Phase 3Results posted
• Linezolid to Treat Extensively-Drug Resistant TuberculosisCompletedNCT00727844Phase 2Results posted
• Metronidazole for Pulmonary Tuberculosis (South Korea)CompletedNCT00425113Phase 2Results posted
• Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary TuberculosisCompletedNCT00396084Phase 1/2Results posted
• Tuberculosis Treatment Shortening TrialCompletedNCT00130247Phase 3Results posted
• Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy HumansWithdrawnNCT06845358Phase 1
• Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant TuberculosisCompletedNCT05586230Phase 1
• PREVAIL VIIIa: Evaluation of Latent Tuberculosis Infection Screening Methods in People Living With Retroviral Infection in LiberiaCompletedNCT04926922
• PREVAIL VIII: A CoHOrt Clinical, Viral, and ImmuNOlogic Monitoring Study of People Living With Retroviral Infection in Liberia (HONOR)CompletedNCT03733093
• Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis PatientsActive, not recruitingNCT03568383Phase 3
• CD8 Reactivity to Microorganisms in Blood and Breast MilkTerminatedNCT03084614
• Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy VolunteersCompletedNCT02771249Phase 1
• Sputum Pharmacokinetics of TB Drugs and Bacterial Drug ResistanceCompletedNCT02534727
• Safety, Tolerability, and Immunogenicity of the Vaccine Candidates ID93 + AP10-602 and ID93 + GLA-SE Administered Intramuscularly in Healthy Adult SubjectsCompletedNCT02508376Phase 1
• NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in TuberculosisCompletedNCT02371681Phase 2
• Immune Responses to Mycobacterium Tuberculosis (Mtb) in People With Latent Tuberculosis Infection With or Without Concomitant Helminth InfectionTerminatedNCT02225158
• Effects of SQ109 on QTc Interval in Healthy SubjectsWithdrawnNCT01874314Phase 1
• Challenge Model for Assessment of Human TB ImmunityCompletedNCT01868464Phase 1
• Effect of PA-824 and of PA-824 Plus Moxifloxacin on the QTc Interval in Healthy VolunteersCompletedNCT01674218Phase 1
• Gene Expression in HIV and Tuberculosis Co-infectionCompletedNCT01611402
• Evaluating the Pharmacokinetics of High-Dose Rifapentine When Given as a Single Dose or in Divided Doses to Healthy AdultsCompletedNCT01574638Phase 1
• Determining Risk in Latent TuberculosisTerminatedNCT01571739
• Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or RifampinCompletedNCT01571414Phase 1
• Effect of Filarial Infection on Immune Responses in Latent TuberculosisCompletedNCT01547884
• Phase 2a EBA Trial of AZD5847CompletedNCT01516203Phase 2
• Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in MaliTerminatedNCT01381757
• Phase IC Study of Safety and PK of SQ109 300mg DailyCompletedNCT01358162Phase 1
• TMC207 +/- Rifabutin/RifampinCompletedNCT01341184Phase 1
• Oral Urea Breath Testing for Diagnosis and Treatment Response in Pulmonary TuberculosisCompletedNCT01301144
• Study of Pre-clearance of Latent Tuberculosis Infection And BCG RevaccinationCompletedNCT01119521Phase 1
• Tuberculosis in ChinaCompletedNCT01071603
• Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy VolunteersCompletedNCT00992069Phase 1
• Measurement of Anti-TB Drugs in Lung Tissue From Patients Having Surgery to Treat TuberculosisCompletedNCT00816426Phase 1
• Efavirenz (EFV) in HIV-Infected and HIV/Tuberculosis (TB) Coinfected ChildrenCompletedNCT00802802Phase 1
• A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case FindingCompletedNCT00414882
• BCG Vaccination Delivered Intradermally, Orally and by Combined RoutesCompletedNCT00396370Phase 1
• Pimonidazole Hydrochloride to Detect Low Oxygen in Tuberculosis-Infected LungsWithdrawnNCT00374517Phase 2
• Multi-Drug Resistant Tuberculosis in KoreaCompletedNCT00341601
• Collection of Tissue Specimens in Mali, West Africa, for HIV and Tuberculosis ResearchTerminatedNCT00341042
• Immune Responses to Mycobacterium TuberculosisCompletedNCT00340990
• A Randomized Trial of DOTS Versus Enhanced DOTS for Community Control of TuberculosisCompletedNCT00317330Phase 3
• Immune Response to Mycobacterium Tuberculosis InfectionCompletedNCT00257907
• Tuberculosis Immunity in ChildrenCompletedNCT00170638
• TB Nutrition, Immunology and EpidemiologyCompletedNCT00170404Phase 3
• Effectiveness of the TB Contact Priority ModelCompletedNCT00149448
• Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in HaitiCompletedNCT00120510Not applicable
• Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected AdultsCompletedNCT00096850Not applicable
• Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited SettingsCompletedNCT00091936Not applicable
• Anti-HIV Drugs for Ugandan Patients With HIV and TuberculosisCompletedNCT00078247Phase 3
• Vitamin A Therapy for TuberculosisCompletedNCT00057434Phase 3
• Tuberculosis in HIV Infected Patients in UgandaCompletedNCT00057421Phase 2
• Tuberculosis Prevention for HIV Infected AdultsCompletedNCT00057122Phase 3
• Diagnosing Tuberculosis in HIV Infected Children in PeruCompletedNCT00054769
• Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based RegimenStatus unknownNCT00018083Not applicable
• Behavioral Interventions for Control of TuberculosisCompletedNCT00005742
• Indigenous Outreach Among Injection Drug Users to Treat and Control TBCompletedNCT00005741
• TB Contact Investigation: Behavioral InterventionCompletedNCT00005740
• Tuberculosis Prophylaxis in the Homeless--A Controlled TrialCompletedNCT00005737
• Randomized Study of Interventions to Enhance Adherence to Isoniazid Prevention Therapy for Tuberculosis in Injection Drug UsersStatus unknownNCT00004740Not applicable
• Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With TuberculosisCompletedNCT00004736Phase 1
• Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV InfectionsCompletedNCT00004276Phase 2
• Interferon Gamma for Drug Resistant TuberculosisCompletedNCT00001407Phase 2
• The Treatment of Tuberculosis in HIV-Infected PatientsCompletedNCT00001033Phase 3
• Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous InfectionCompletedNCT00000959Not applicable
• Two-Stage Tuberculin (PPD) Skin Testing in Individuals With Human Immunodeficiency Virus (HIV) InfectionCompletedNCT00000955Not applicable
• Metabolism of Antituberculosis Drugs in HIV-Infected Persons With TuberculosisCompletedNCT00000950Not applicable
• A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.CompletedNCT00000796Not applicable
• A Registry of Tuberculosis Cases in the CPCRACompletedNCT00000785
• A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and LevofloxacinCompletedNCT00000778Phase 1
• Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous InfectionCompletedNCT00000638Not applicable
• Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous InfectionCompletedNCT00000636Not applicable