Active clinical trials for "Tuberculosis"

The primary objective of this multi-center sub-study of USPHS Study 23: "Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid with Daily Efavirenz in Combination with Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections," is 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. Secondary objectives are: (1) To describe pharmacokinetics of both rifabutin and efavirenz in combination regimen, (2) To evaluate the safety of concomitant efavirenz and rifabutin, (3) To assess the effect on absolute neutrophil count by changing rifabutin dose and adding efavirenz to the regimen, (4) To develop models of optimal sampling times for rifabutin dosed twice a week, (5) To describe the pharmacokinetics of isoniazid in combination with efavirenz daily with two NRTIs, (6) To compare the pharmacokinetics of isoniazid with and without efavirenz.

To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.

This work aims to assess cardiopulmonary function and quality of life in people with sequelae of pulmonary tuberculosis undergoing rehabilitation. It is an experimental clinical study, with evaluation before and after the intervention. Included participants will be randomized and divided into a control group and an intervention group. Quality of life is examined by two questionnaires and physical fitness by specific tests, before and after the intervention. The intervention is the realization of a supervised physical exercise protocol.

The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients.

This study is a randomized, controlled, multi-center clinical study. The main purpose of this study was to study the efficacy and safety data of total oral short-term therapy as an alternative to injection in the treatment of newly diagnosed RR-TB patients.

To investigate whether implantation of cobalt alloy pedicle screws is effective in treating severe kyphosis deformity in spinal tuberculosis, and to determine the factors that are likely to have influenced the curative effects.

Tuberculosis (TB) is one opportunistic infection often seen in HIV individuals. In 2013, there were an estimated 31,800 HIV-TB co-infection cases and 6,100 HIV-related deaths due to TB in the Americas. Due to the non-specific nature of its clinical symptoms, TB can be confused with various diseases such as histoplasmosis, sarcoidosis, lymphoma, and pneumonia. In Panama, where Histoplasma capsulatum is endemic, diagnosing TB versus histoplasmosis based on clinical symptoms can be difficult. In Panama, approximately 7.65% of HIV patients are co-infected with histoplasmosis, and there is a 30% mortality rate in HIV-histoplasmosis patients in Latin America. Due to similar clinical features, misdiagnosis of active TB and disseminated histoplasmosis in endemic regions may lead to incorrect antibiotic management, which in turn results in unnecessary toxicity, antibiotic resistance, and monetary expenditures. The investigators interests lie in increasing TB diagnostic accuracy using a simple urine dipstick test and evaluating physician response to new diagnostic testing, in order to reduce misdiagnosis and improve health outcomes in the HIV population.

The Tuberculosis Trials Consortium (TBTC) phase 3 treatment trial, Study 31, will investigate the efficacy and safety of daily rifapentine (1200 mg daily) with or without moxifloxacin as part of multidrug treatment regimens for drug-sensitive pulmonary TB. The proposed study (Study 31 PK/PD) will examine the population pharmacokinetics and pharmacodynamics (PK/PD) of high-dose daily rifapentine with and without moxifloxacin given for 17 weeks. Two different PK sampling procedures are required for the population PK/PD assessments involving rifapentine and moxifloxacin: (1) intensive sampling of 6 samples/participant on one occasion plus subsequent sparse sampling for a subset of Study 31 participants who are invited to co-enroll in Study 31 PK/PD; and (2) sparse sampling of 2-3 samples/participant for all other Study 31 trial participants (these data will be collected as part of the Study 31 treatment protocol). Herein, we describe the PK sampling to be conducted among those Study 31 participants who are co-enrolled to Study 31 PK/PD (n=60). Intensive PK sampling is needed in some participants to estimate the population PK model parameters with no bias and satisfactory precision (relative standard error < 20%). PK and outcomes data from all participants in Study 31 will be merged to build the population PK/PD models to evaluate PK/PD parameters. Details regarding these planned analyses are also provided in this Study 31 PK/PD protocol. Primary Objectives: Characterize the population pharmacokinetics of rifapentine and 25-desacetyl rifapentine, using sparse PK data from Study 31 and intensive PK data from Study 31 PK/PD. Using the population PK model, determine post-hoc Bayesian estimates of individual-level PK parameters. Examine the relationship between rifapentine PK parameters of interest and treatment efficacy. PK parameters will include area under the concentration time curve (AUC0-24), peak concentration (Cmax), time above the mean inhibitory concentration (MIC), and AUC/MIC. The treatment outcome of interest will be time to culture conversion and time to treatment failure or relapse. Secondary Objectives: Among the Study 31 participants in the lowest 10% for rifapentine AUC0-24, examine the PK/PD effect on culture conversion of sputa after completion of 4 months of daily rifapentine therapy. Examine the relationship between safety outcomes (Grade 3 or higher adverse events) and rifapentine PK parameters (AUC0-24, Cmax, AUC0-24/MIC and time above MIC). Characterize the population PK of moxifloxacin, and then estimate moxifloxacin AUC0-24 and Cmax when moxifloxacin is administered with rifapentine given at a daily dose of 1200 mg. Examine the relationships between moxifloxacin PK and treatment outcomes (as described in objective 2 for rifapentine) and moxifloxacin PK and safety (as described in objective 4 for rifapentine). Design: In Study 31 PK/PD, among 60 participants with tuberculosis enrolled in a rifapentine-based treatment arm of Study 31, PK data will be collected on two occasions. At TBTC sites that have the capacity to perform this activity, participants will have 6 scheduled PK samples per participant collected to measure rifapentine (with or without moxifloxacin) concentrations over approximately 24 hours. In addition among these 60 participants, 2 to 3 scheduled PK samples will be obtained on a second "late" sampling at > 14 days after the first PK sampling.

TB PRACTECAL is a multi-centre, open label, multi-arm, randomised, controlled, phase II-III trial; evaluating short treatment regimens containing bedaquiline and pretomanid in combination with existing and re-purposed anti-TB drugs for the treatment of biologically confirmed pulmonary multi drug-resistant TB (MDR-TB).

Tuberculosis (TB) is a leading cause of death in HIV-infected individuals. There are insufficient data correlating concentrations of anti-TB drugs with treatment response. We hypothesize that sub-therapeutic concentrations of anti-TB drugs are associated with inadequate TB treatment response to Mycobacterium tuberculosis.