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Tuberculosis clinical trials

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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: 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.

NCT ID: NCT00396084 Completed - Tuberculosis Clinical Trials

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Start date: February 10, 2004
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.

NCT ID: NCT00395720 Completed - HIV Infections Clinical Trials

The Safety and Immunogenicity of a TB Vaccine; MVA85A, in Healthy Volunteers Who Are Infected With HIV

Start date: November 2006
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4 weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A intradermally in this study. Subjects will be identified from HIV clinics in the Oxford Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's Hospital NHS Trust if our recruitment targets are not met.

NCT ID: NCT00366470 Completed - Clinical trials for Pulmonary Tuberculosis

A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

Start date: November 2009
Phase: Phase 3
Study type: Interventional

There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

NCT ID: NCT00351702 Completed - Tuberculosis Clinical Trials

Preventive Therapy for Tuberculosis in HIV Infected Persons

Start date: February 2001
Phase: Phase 3
Study type: Interventional

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons Phase: Phase III trial Population: 650 HIV positive patients without tuberculosis Number of sites: Three 1. Tuberculosis Research centre, Chennai 2. Government General Hospital, Chennai 3. Government Rajaji Hospital, Madurai Study Duration: 36 months Study Objectives: To compare the efficacy of two TB preventive therapy regimens in reducing the incidence of tuberculosis and mortality among HIV-infected persons Study Design: The study will be a two-armed prospective randomized clinical trial among HIV- positive patients without active tuberculosis. Enrolled patients will be assigned to one of the two unsupervised self-administered treatment regimens i.e. EH for 6 months or INH alone for 3 years. At the end of a 3-year follow-up, incidence of TB and overall mortality will be compared in each group. Study Endpoints:The primary end point of the study will be development of tuberculosis and the secondary endpoints will include adverse drug reactions and mortality rate.

NCT ID: NCT00346476 Completed - HIV Infections Clinical Trials

Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa

Start date: April 2006
Phase: N/A
Study type: Observational

The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. This study will also examine the genetics of TB and the relationships among active TB infection, new HIV infections, and HIV disease progression.

NCT ID: NCT00342017 Completed - Filarial Infection Clinical Trials

The Effect of Parasitic Worm Infections on the Immune Response to Tuberculosis Bacteria

Start date: May 20, 2002
Phase: N/A
Study type: Observational

This study, sponsored by the National Institutes of Health and the Tuberculosis Research Centre in Chennai, India, will examine how helminth and filarial infections affect the immune response to mycobacteria (the bacteria that causes tuberculosis). Helminths are parasitic worms that infect the gut, and filaria are worms that circulate in the blood and infect various tissues. The findings of this study may affect how tuberculosis is assessed in Chennai, where filarial and helminth infections are common in the population. Patients between 6 and 65 years of age with helminth or filarial infections who do not have active tuberculosis, cancer, AIDS, or other immunosuppressive illness may be eligible for this study. Participants will be recruited from villages in the Chingleput District of Chennai, India. Participants will complete a medical history and physical examination. They will have a blood test to determine red blood cell count and to detect filarial infection, a stool examination to detect helminth infection, and a tuberculin skin test for tuberculosis. Patients with a positive tuberculin test will be treated for tuberculosis and any filarial or helminth infections that may have been detected. Patients whose tuberculin test is negative will be invited to participate in the second part of the study-to determine whether people with either filarial infections or helminth infections, or both, respond to tuberculosis bacteria in the same way as people who do not have these infections. Participants will undergo a review of their medical history, a physical examination, and a blood test to assess red blood cell levels and to look for evidence of filarial or helminth infection. They will then be randomly assigned to receive either albendazole and DEC (anti-helminth and anti-filarial drugs) or a placebo (look-alike tablets that do not contain an active ingredient). Two months later, patients will receive a second dose of the same tablets (placebo or active drug) they took previously, and after another 4 weeks they will be re-tested for tuberculosis. After 6 months (at the end of the study) all participants will receive anti-helminth and anti-filarial drugs and will have a repeat tuberculin skin test. Blood and stool samples will be collected twice in the 6-month period after the initial treatment to determine the levels of antibody against the parasites, to measure the level of infection with filaria, and to measure the level of red blood cells.

NCT ID: NCT00341601 Completed - Tuberculosis Clinical Trials

Multi-Drug Resistant Tuberculosis in Korea

Start date: January 3, 2005
Phase:
Study type: Observational

This study, conducted in Korea, will examine why some people are more susceptible to tuberculosis (TB) than others and why some strains of M tuberculosis (the bacteria that causes TB) are more difficult to treat or become resistant to drug treatments. The study will compare blood samples and other medical information from patients with different kinds of tuberculosis and with healthy volunteers to identify patient and bacterial characteristics that contribute to disease susceptibility, treatment failure, disease recurrence and multi-drug resistance. Healthy volunteers and patients with tuberculosis who are 20 years of age or older may be eligible for this study. Subjects are recruited from among patients receiving treatment for tuberculosis at the National Masan Tuberculosis Hospital in the Republic of Korea and from healthy people visiting government health care centers for annual medical checkups. The latter include people who have had TB but are cured; people who have been exposed to TB, but currently have no signs of disease; and those who have not been exposed to TB. Participants with tuberculosis undergo the following tests and procedures: - Medical history, including past treatments for TB, and review of medical records - Interview about home and work - Sputum collection to test for the kind of TB bacteria present and for genetic studies of the bacteria - Drug treatment for TB - Blood draws as part of regular patient care, for HIV testing, and for genetic studies - Chest x-rays as part of routine patient care - In patients with recurrent disease, examination of the strains from both bouts of disease to determine if it is a recurrence of the same organism or infection with a new strain. Healthy volunteers undergo the following tests and procedures: - Brief medical history - Blood draw to look for exposure to TB and for genetic studies - Review of previous x-ray to look for active TB