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Tuberculosis clinical trials

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NCT ID: NCT00653770 Completed - Tuberculosis Clinical Trials

A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A

Start date: September 2007
Phase: Phase 1
Study type: Interventional

This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later.

NCT ID: NCT00653627 Completed - Tuberculosis Clinical Trials

A Study to Quantify Bacille Calmette Guerin (BCG) and Characterise the Immune Response After BCG Vaccination

Start date: August 2007
Phase: Phase 1
Study type: Interventional

This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A) the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods of mycobacterial quantification on these tissue samples will then be compared

NCT ID: NCT00651066 Completed - HIV Infections Clinical Trials

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in Vietnam

Start date: June 2010
Phase: Phase 2
Study type: Interventional

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

NCT ID: NCT00647205 Completed - HIV Infections Clinical Trials

Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.

NCT ID: NCT00645697 Completed - Tuberculosis Clinical Trials

Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

AVA-ION
Start date: January 2007
Phase: Phase 4
Study type: Observational

One complication of uveitis which is driven by an increase in VEGF is the formation of inflammatory ocular neovascularization (ION). Here, we analyze the therapeutic role of intravitreal bevacizumab in ION not responding to standard therapy (systemic and ocular corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.The natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis, Harada and other inflammatory chorioretinal disorders has been very guarded, but with this new approach, we hope to stop the visual loss in these relatively young patients.

NCT ID: NCT00640887 Completed - HIV Infections Clinical Trials

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

NCT ID: NCT00621322 Completed - Tuberculosis Clinical Trials

Safety and Immunogenicity Study of GSK Biologicals Tuberculosis Vaccines (692342) to Healthy Adults

Start date: April 3, 2008
Phase: Phase 2
Study type: Interventional

This observer blind study will assess the safety and immunogenicity of different formulations of GSK Biologicals' 692342 tuberculosis vaccine in healthy adults aged 18 to 45 years with a positive PPD skin test. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00617643 Completed - HIV Infections Clinical Trials

Nevirapine Drug Levels in HIV Positive Patients Also Receiving Rifampicin for Tuberculosis

Start date: May 2008
Phase: Phase 4
Study type: Interventional

Triomune is the most commonly prescribed treatment for HIV infection in Uganda. Triomune is manufactured by a generic drug company and consists of three drugs combined in a single pill given twice daily (stavudine 30mg plus lamivudine 150mg plus nevirapine 200mg). It is known that the levels of nevirapine in a patient's blood are highest in the first two weeks of treatment. Therefore it is recommended that patients starting on nevirapine should undergo dose escalation i.e start on 200mg once daily for two weeks and then increase to full dose of 200mg twice daily in order to avoid nevirapine related rash. It is not possible to do dose escalation with a fixed dose combination pill like Triomune and for the two weeks of the dose escalation patients either can buy stavudine plus lamivudine plus nevirapine as separate pills or take Triomune in the morning and then take stavudine plus lamivudine as separate pills in the evening. Rifampicin is used to treat TB and lowers the levels of nevirapine in a patient's blood. This raises two questions in routine clinical practice for patients who are co-infected with HIV and TB (1) Do we need to put our patients to the trouble of dose escalation of nevirapine if they are already on rifampicin? and (2) If we dose escalate nevirapine in patients on rifampicin, are we putting them at risk of low drug levels and development of resistance? The aim of this study is to compare the plasma concentrations of nevirapine in HIV infected patients who are commencing antiretroviral therapy with and without a lead in dose of nevirapine and who are also receiving concomitant treatment with antituberculous therapy which includes rifampicin to assess whether dose escalation of nevirapine is appropriate in this patient population

NCT ID: NCT00604617 Completed - HIV Clinical Trials

Interferon-Gamma Release Assays in Tuberculosis (TB) - HIV Co-infected Children

Start date: January 26, 2009
Phase:
Study type: Observational

Tuberculosis (TB) is a disease affecting the lungs that is caused by a germ spread by coughing. TB infection is currently diagnosed by a skin test that has limited accuracy. The purpose of this study is to look at the reliability of a new blood test for diagnosing TB infection in children. Study participants will include 300 HIV-infected (HIV infection is a viral infection that causes disease which destroys the body's ability to protect itself from infection and disease.) children and 500 HIV-uninfected children, ages 3 months to 5 years, residing in the Khayelitsha and Ravensmead/Uitsig Communities of the Western Cape Province, South Africa. Study procedures will include questionnaires, HIV and TB testing, which will be performed by blood and skin tests. Participants may be involved in study related procedures for up to 24 months.

NCT ID: NCT00600782 Completed - Tuberculosis (TB) Clinical Trials

Immunogenicity and Safety of a Candidate Tuberculosis (TB) Vaccine Given to Healthy Adults in a TB-endemic Region

Start date: February 5, 2008
Phase: Phase 2
Study type: Interventional

This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.