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Tuberculosis clinical trials

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NCT ID: NCT00685360 Completed - Clinical trials for Tuberculosis, Pulmonary

A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)

Start date: May 8, 2008
Phase: Phase 2
Study type: Interventional

This is a clinical trial to evaluate the safety and efficacy of OPC-67683 in the treatment of multidrug resistant tuberculosis (MDR TB) for 56 days. In addition to an optimized background regimen (OBR), participants will be randomized to receive: - 100 mg OPC-67683 twice daily (BID) - 200 mg OPC-67683 BID - Placebo BID After 56 days participants will complete their optimized background regimen (OBR).

NCT ID: NCT00682045 Completed - Renal Transplant Clinical Trials

Latent Tuberculosis Infection in Renal Transplant Recipients

Start date: June 2008
Phase: N/A
Study type: Observational

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. T-SPOT.TB assay) for diagnosis of latent tuberculosis infection (LTBI) in renal transplant recipients. For this purpose, the investigators enrolled renal transplant recipients and observed the developement of tuberculosis within 1 to 2 years after the transplantation.

NCT ID: NCT00679159 Completed - Tuberculosis Clinical Trials

A Study of MVA85A in Healthy Children and Infants

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

This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10^7, 5 x 10^7 or 1 x 10^8 pfu. Participants will be identified from the general population living in Worcester, Western Cape, South Africa

NCT ID: NCT00677339 Completed - Clinical trials for Smear Positive Pulmonary Tuberculosis

L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)

AVDAPT
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can improve response to standard short course TB therapy in people with newly diagnosed pulmonary TB.

NCT ID: NCT00675961 Completed - Tuberculosis Clinical Trials

Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia

IMPACT
Start date: January 2007
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess the effectiveness of two alcohol interventions administered singly or in combination as an integrated component of TB care provided to patients with co-occurring TB and AUDs in Tomsk, Russia. Here we propose two parts of this study: First, a pilot study to provide Naltrexone to TB patients will be conducted. If feasibility and safety are demonstrated, then we will conduct a randomized clinical trial (RCT) of the following four study arms: 1. A Behavioral Counseling Intervention (BCI) plus treatment as usual (TAU) (i.e. standard referral to and management by an addictions specialist); 2. Naltrexone/ Brief Behavioral Compliance Enhancement Treatment (BBCET) plus TAU 3. BCI + Naltrexone/BBCET plus TAU 4. TAU The RCT will be conducted only if Naltrexone use proves safe and feasible in the pilot study. However, because the pilot does not have a control group and nor is it a Phase I clinical trial, we define "safety" here as demonstration of appropriate adverse event management and adequate safety monitoring procedures, all of which will also be used in the RCT. The specific aims of the pilot are: 1. To determine the feasibility of administering Naltrexone to patients receiving TB treatment, and 2. To assess the safety of administering Naltrexone to patients receiving TB treatment. The investigators aim to test the following hypotheses for the pilot: co-administration of Naltrexone with TB treatment is feasible and safe in a population of TB patients with AUDs. The specific aims of the RCT are: 1. To compare TB treatment outcomes among patients in each of the three intervention arms with the control arm of treatment as usual, and 2. To compare the change in mean number of heavy drinking days in last month of study period compared with baseline among patients in each of the three intervention arms with the control arm of treatment as usual. The investigators aim to test the following hypotheses for the RCT: Individuals receiving one of the three interventions (Naltrexone, BCI or the combination of Naltrexone/BCI) will experience better TB outcomes and a greater change in the mean number of heavy drinking days, compared with individuals receiving treatment as usual.

NCT ID: NCT00664313 Completed - Clinical trials for Multi-drug Resistant Tuberculosis

TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB

LiMiT
Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)

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.