Phase IC Study of Safety and PK of SQ109 300mg Daily
TuberculosisHealthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the safety and tolerability and pharmacokinetics.
Corticosteroids in the Treatment of Tuberculous Pleurisy
Tuberculous PleurisyTuberculous pleurisy is associated with inflammation and fibrosis. Adjunctive corticosteroids are used for tuberculous pleurisy because their anti-inflammatory effect is thought to minimise pleural reactivity and thereby reduce residual pleural thickening. The purpose is to evaluate the efficacy and safety of oral prednisolone for treatment of adult patients with tuberculous pleurisy.
Tuberculosis (TB) Immunotherapy Phase 2 Study
TuberculosisThis is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.
TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment
TuberculosisThis double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.
TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
HIV InfectionsTuberculosisPrimary Objectives: 1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin. Secondary Objectives: To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB
HIV InfectionsTuberculosisPrimary Objective: To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy. Secondary Objectives: To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin. To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis. To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis. To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
HIV InfectionsTuberculosisThe aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults...
TuberculosisTuberculosis1 morePartially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis...
TuberculosisThe purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin. The results of this trial will determine the imatinib dose to be studied in a subsequent Phase IIB treatment trial of imatinib as an adjunctive therapy with an antimicrobial regimen (rifabutin, pyrazinamide (PZA), isoniazid (INH) and ethambutol) for drug-sensitive TB.
Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
Malignant Solid TumorInvariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.