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Tuberculosis clinical trials

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NCT ID: NCT00421798 Completed - Clinical trials for Mycobacterium Tuberculosis

Rapid Characterization of Paucibacillary TB Along Tex/Mex Border

Start date: January 2007
Phase: N/A
Study type: Observational

This study will test a method of detecting tuberculosis-causing bacteria that are resistant to current medication treatments. Blood samples will be collected from patients from 3 sites and 3 mainly Hispanic populations in Texas, Mexico, and Colombia. Up to 780 males and females, ages 18-85 years, will participate. The study population will consist of 390 people with any of 3 forms of tuberculosis (TB) and 390 people who are either healthy or with a disease initially thought to be one of these 3 forms of TB but then ruled out. Volunteers will only be contacted, invited to participate and interviewed at the beginning of their evaluation for possible TB.The study team will follow up with the health department to determine if the volunteer was indeed diagnosed with TB, and with the laboratory to determine the results of TB tests at diagnosis and during the course of treatment.

NCT ID: NCT00419068 Completed - Clinical trials for Tuberculosis, Pulmonary

Trial of Adjunctive Vitamin D in Tuberculosis Treatment

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.

NCT ID: NCT00414882 Completed - Clinical trials for Mycobacterium Tuberculosis

A Cluster-Randomized Trial of DOTS vs DOTS Plus Active Case Finding

Start date: July 10, 2007
Phase:
Study type: Observational

The purpose of the study is to see if one plan for identifying and treating tuberculosis (TB) works better than another in reducing new cases of TB. The first plan is the DOTS program, which provides free TB treatment to people seeking it. The second plan provides free TB treatment to people seeking it and involves program staff going door-to-door in communities to identify new cases of TB, DOTS plus active case-finding program (ACF). Researchers believe that by detecting TB cases earlier and supervising treatment it will help to prevent spreading and decrease TB in these areas. The study population will be 200,000 people in 6 communities of Santa Cruz and 14 communities of Northeast Rio de Janeiro, Brazil, receiving DOTS or DOTS plus ACF. Individuals in the DOTS plus ACF part of the study will be interviewed 2-4 times during a 9 month period. Patients with symptoms will provide a sputum specimen. Patients identified as having TB will begin treatment and be observed for 6.

NCT ID: NCT00412009 Completed - Tuberculosis Clinical Trials

Investigation of a Novel Approach to Improve Treatment Success Rates for Tuberculosis Patients in Senegal

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Tuberculosis (TB) patients who receive inadequate treatment or do not complete therapy are more likely to remain infectious, thus contributing to the continuous spread of TB infection in communities. Despite the widespread use of Directly Observed Therapy, defaulters remain an important problem in TB control programmes. In Sénégal, defaulters rate reach 30%, which is hampering dramatically the effectiveness of control. New strategies to deliver treatment to TB patients and ensure proper adherence that are adapted to the local situations are urgently needed. Objectives The overall objective of the project is to improve tuberculosis treatment success rates in Sénégal. The specific objectives are: 1. to assess the current situation of tuberculosis (TB) in Sénégal 2. to identify the determinants of cure, 3. to develop measures to improve patient’s compliance with the treatment that are adapted to the local situation, acceptable, affordable and sustainable 4. to evaluate the impact of these measures on TB control. Methods The proposed research seeks to develop and test innovative methods to improve cure rates in TB patients. It will explore the factors of success of TB treatment using inter-disciplinary approach, integrating social sciences and economic analyses into TB research. The project is composed of 3 comprehensive phases: - Phase 1: baseline assessment of the TB situation. - Phase 2: anthropological study, investigating various domains contributing to patients cure using a range of qualitative research methods. At the end of this investigation, it is expected that determinants of care will be clearly identified. On this basis, suitable methods for improving patients’ adherence to treatment will be tailored and developed. - Phase 3: these methods will be tested and compared using a cluster randomised controlled trial design, in populations served by defined health centres. Their efficacy will be measured in terms of improvement of the classical TB control programme indicators (cure rate, defaulter rate, failure rate, death rates). The methods will also be evaluated on their acceptability by the TB patients and the communities and on their feasibility (duration : 24 months). Expected results: Methods to improve patients’ adherence to treatment that are affordable, acceptable and sustainable will be developed and tested according to qualitative and quantitative criteria.

NCT ID: NCT00411996 Completed - HIV Infections Clinical Trials

The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin

Start date: December 2006
Phase: Phase 1/Phase 2
Study type: Interventional

We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.

NCT ID: NCT00405301 Completed - Tuberculosis Clinical Trials

Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Anti-TB Drugs Induced Liver Damage

Start date: December 2006
Phase: Phase 4
Study type: Interventional

Purpose of the study is to evaluate the safety and efficacy of different re-introduction regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such patients who developed drug induced liver damage.

NCT ID: NCT00402610 Completed - HIV Infections Clinical Trials

A Randomized Trial of Three Regimens to Prevent Tuberculosis in HIV-Infected Patients With Anergy

Start date: January 1994
Phase: Phase 4
Study type: Interventional

INTRODUCTION. To evaluate the efficacy of three regimens of prophylactic therapy for tuberculosis in HIV-infected patients with anergy. METHODS. Prospective, multi-center, randomized, comparative, and open clinical trial. Anergy was defined as absence of induration in response to three antigens (PPD, Candida albicans and parotiditis antigen) applied by the Mantoux method. Patients were randomized into one of the following prophylactic treatment groups: isoniazid for six months (6H), rifampin plus isoniazid for three months (3RH), rifampin plus pyrazinamide for two months (2RZ) or no treatment (NT). After completion of treatment, patients were followed up for two years.

NCT ID: NCT00402454 Completed - HIV Infections Clinical Trials

Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

Start date: January 1994
Phase: Phase 4
Study type: Interventional

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.

NCT ID: NCT00402402 Completed - Tuberculosis Clinical Trials

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI

NCT ID: NCT00401271 Completed - Clinical trials for Pulmonary Tuberculosis

Safety, Efficacy and Pharmacokinetics of OPC-67683 in Patients With Pulmonary Tuberculosis

Start date: November 2006
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate the safety, efficacy and pharmacokinetics of 100mg, 200mg , 300mg and 400mg once daily of OPC-67683, administered orally for 14 consecutive days, in patients with uncomplicated, smear-positive pulmonary TB. The four OPC-67683 treatment groups will comprise 12 patients each and the one standard therapy (Rifafour e-275) group six patients. Trial 242-06-101 is an exploratory and not a confirmatory trial and as such no hypothesis will be tested statistically. The control group, six patients treated with Rifafour, will serve as an control to confirm the microbiological assessments during the trial.