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Tuberculosis clinical trials

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NCT ID: NCT00541294 Completed - HIV Infections Clinical Trials

Diagnosis of Tuberculosis Infection in HIV Co-infected Children

ThrasherIGRA
Start date: January 15, 2008
Phase:
Study type: Observational

Background: The TB and HIV epidemics are closely linked in developing countries, where 450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children and is reversing gains made in child survival. The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker, more accurate way to diagnose TB infection. Such diagnostic testing may directly guide clinical management and preventive strategies in immune-suppressed HIV-infected children, who are at high risk of becoming TB diseased following infection. Data regarding the usefulness of these tests in children is currently limited. Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic testing can accurately identify children with TB infection. In a community with high rates of TB and HIV infection, the following specific aims will be investigated in HIV-infected and uninfected children: 1. assess the agreement between the TST and blood-based diagnostic testing, 2. compare the performance of the TST and blood-based diagnostic testing to a standardized history of TB exposure, 3. measure the impact of age, nutritional and immune status on children's response to blood-based testing, 4. describe factors that might modify children's response to testing over time, and 5) examine the effect of environmental exposures and previous vaccination on the TST, blood-based testing and other measures of immune responses to TB. Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in children include 1) timely institution of treatment for TB infection to prevent severe disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of childhood TB infection also prevents future contagious adult disease, thus decreasing community transmission. Blood-based diagnostic testing may also be able to identify children that are more likely to become ill following TB infection. Therefore, blood-based diagnostic testing has great potential to improve TB control and the health of HIV-infected and uninfected children, their households and communities.

NCT ID: NCT00533390 Terminated - HIV Infections Clinical Trials

Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg

IPEC-EFV
Start date: January 2007
Phase: Phase 4
Study type: Interventional

Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800 mg dose would be more adequate than the 600mg

NCT ID: NCT00524147 Completed - Clinical trials for Tuberculous Pleurisy

Drainage of Tuberculous Pleural Effusions

Start date: October 2003
Phase: N/A
Study type: Interventional

Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.

NCT ID: NCT00523926 Completed - Tuberculosis Clinical Trials

TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis

Start date: May 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effects of 3 different oral doses of TMC207 administered over a 7 day period on the organism that causes tuberculosis

NCT ID: NCT00523458 Terminated - HIV Infections Clinical Trials

A Study to Determine the Best Dose of Antivirals in Patients With Both TB and HIV

OPTI-NNRTI
Start date: July 2007
Phase: Phase 4
Study type: Interventional

Because drugs used to treat TB can reduce the amount of the anti-HIV drugs that reach the sites where the virus is located, this study is designed to see whether it is necessary to use higher doses of antiviral (anti-HIV) drugs while patients are receiving therapy with rifampin, one of the drugs commonly used to treat TB. Participants will be assigned to one of 4 arms (see below) and will be followed during the time when they are receiving both treatments.

NCT ID: NCT00517231 Withdrawn - Clinical trials for Pulmonary Tuberculosis

Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment

Start date: June 2005
Phase: N/A
Study type: Observational

Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy.

NCT ID: NCT00513396 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

High-Dose Isoniazid Adjuvant Therapy for Multidrug Resistant Tuberculosis

Start date: January 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The need for a standardized treatment protocol for multidrug resistant tuberculosis (MDR-TB) in resource-limited countries is being increasingly recognized. This single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of MDR pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. The study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of MDR-TB without significantly increasing the toxicity.

NCT ID: NCT00512330 Recruiting - Tuberculosis Clinical Trials

Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)

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

In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults. Our study aims to evaluate this test in the diagnosis of children with TB.

NCT ID: NCT00507754 Completed - Advanced Cancer Clinical Trials

Latent Tuberculosis Infection in Cancer Patients

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

Primary Objective: 1. To evaluate the performance of the new T-SPOT.TB test and the conventional TST for screening of Latent Tuberculosis infections in patients with cancer and those undergoing Hematopoietic Stem Cell Transplant. Secondary Objectives: 1. To examine the factors associated with positive response to T-SPOT.TB and the TST (tuberculin skin test) in patients with anergy. 2. To determine the impact of immunosuppressive and antineoplastic therapy on the screening performance of T-SPOT.TB and the TST in cancer patients.

NCT ID: NCT00507000 Active, not recruiting - Tuberculosis Clinical Trials

Pulmonary Tuberculosis and Vitamin D

Start date: May 2008
Phase: Phase 3
Study type: Interventional

Tuberculosis and vitamin D deficiency are important public health problems in India. Before the advent of effective antitubercular therapy, patients with tuberculosis were advised treatment and rest at sanatorium where sunshine was available in plenty. There have been reports associating vitamin D deficiency with tuberculosis in terms of incidence and beneficial response following addition of vitamin D to antitubercular therapy. Sputum AFB conversion rate is higher in patients with tuberculosis supplemented with vitamin D. The present study would systematically assess role of adjunct vitamin D therapy (cholecalciferol) in patients with pulmonary tuberculosis.