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Tuberculosis clinical trials

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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.

NCT ID: NCT00398996 Completed - HIV Infections Clinical Trials

A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

SAPIT
Start date: June 2005
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients: Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.

NCT ID: NCT00397943 Completed - Tuberculosis Clinical Trials

Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults

Start date: November 15, 2006
Phase: Phase 2
Study type: Interventional

This study will assess the safety and immunogenicity of 2 different formulations of tuberculosis vaccine GSK692342 in healthy adults.

NCT ID: NCT00397709 Terminated - Tuberculosis Clinical Trials

Short-Course Isoniazid and Rifampin Compared With Isoniazid for Latent Tuberculosis Infection

Start date: March 1996
Phase: Phase 4
Study type: Interventional

The objective of the study was to compare the compliance and the side effects of a short course to treatment of latent tuberculosis infection during 3 months(isoniazid plus rifampin)group I, with the standard course for 6 months(isoniazid)group II .Prospective, comparative, randomized and open trial of patients with positive TST and the suitable criteria for treatment, in accordance with the guidelines of the CDC, excluding HIV infection. 105 patients were included. In Conclusion, a short course with isoniazid plus rifampin during 3 months shown better compliance with a lower percentage of abandonment that the course 6H. Tolerance is similar in the two courses.

NCT ID: NCT00396370 Completed - Tuberculosis Clinical Trials

BCG Vaccination Delivered Intradermally, Orally and by Combined Routes

Start date: December 2, 2008
Phase: Phase 1
Study type: Interventional

This study will assess the safety of a Bacillus Calmette-Guérin (BCG) vaccine against tuberculosis (TB) and will evaluate if giving the vaccine by mouth, injection, or by both methods produces greater results. BCG vaccine and/or placebo (substance containing no medication) will be given by mouth and/or by injection into the skin. This study, conducted at Saint Louis University, will enroll 60 (up to 80) healthy volunteers, 18-40 years old, who are negative for a TB test (QuantiFERON®-Gold) and human immunodeficiency virus (HIV). Study procedures will include a physical exam; review of TB exposure history and medical history; collection of multiple samples of blood, urine, stool, tears, and nose fluid; and skin and blood tests for TB. Volunteers may participate for about 24 months.