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Tuberculosis clinical trials

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NCT ID: NCT01722396 Completed - Tuberculosis Clinical Trials

Pharmacogenetics of Vitamin D Supplementation in Tuberculosis

Start date: March 2011
Phase: Phase 3
Study type: Interventional

Previous studies of vitamin D supplementation have suggested there may be differences in response between individuals. This study is an open label study of vitamin D supplementation in patients with active or latent tuberculosis in which active disease patients take 100000units of vitamin D every 8 weeks during their tuberculosis treatment. Genotyping for relevant vitamin D pathway polymorphisms will be carried out and related to clinical and ex vivo markers of vitamin D response. Latent patients will only be studied for vitamin D response ex vivo. Our hypothesis is that response to vitamin D in both monocytes and T cells will be related to polymorphisms in the DBP gene, and that this may relate to clinical response in terms of post supplementation vitamin D level.

NCT ID: NCT01705041 Completed - HIV Clinical Trials

Preliminary Evaluation of a Point-Of-Care Liver Function Test

DFA
Start date: June 2012
Phase: N/A
Study type: Interventional

The proposed preliminary field evaluation will compare a point-of-care (POC) transaminase test with the standard of care test used in an HIV clinic at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.

NCT ID: NCT01704144 Recruiting - HIV Clinical Trials

Rifampin and Efavirenz Interactions in Older Children

Start date: October 2012
Phase: N/A
Study type: Observational

Efavirenz is an essential component of HIV treatment in children aged 3 years or older on anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during anti-TB treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the drug metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between the HIV and anti-TB drugs also vary between individuals based on genetic factors. This study will investigate the effects of anti-TB treatment, as well as drug-gene interactions on the blood concentrations of efavirenz in children with HIV and TB infections. Such data could enhance optimization of efavirenz dosage or selection of alternate regimens in some children.

NCT ID: NCT01700790 Terminated - Tuberculosis Clinical Trials

Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir Given With Rifampin

Start date: February 2016
Phase: Phase 4
Study type: Interventional

The object of this study is to evaluate the pharmacokinetic interactions, short term safety and efficacy of standard dose lopinavir/ritonavir 200mg/50 (two tablets twice daily) given with ritonavir 100 mg three tablets twice daily given in combination with rifampin in HIV-infected persons with tuberculosis

NCT ID: NCT01699633 Recruiting - HIV Clinical Trials

Rifampin and Nevirapine Interactions in Young Children

Start date: October 2012
Phase: N/A
Study type: Observational

Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for treatment of HIV in children younger than 3 years old who have tuberculosis (TB) coinfection. However, there is very limited data on the drug-drug interactions between rifampin and nevirapine in children of this age group. The purpose of this study is to determine the effect of rifampin-containing anti-TB treatment on the blood levels of nevirapine in young children with HIV and TB coinfection. Also, the study will find out whether checking the genetic makeup of a child could help to determine the appropriate dose of nevirapine in the setting of concomitant anti-TB treatment.

NCT ID: NCT01698476 Completed - Clinical trials for Pulmonary Tuberculosis (TB)

Immune Reconstitution in Tuberculosis Disease

IRETB
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The aim with study is to provide adjunctive therapy with vitamin D and phenylbutyrate together with standard anti-tuberculosis treatment to significantly improve clinical recovery among patients with untreated, active pulmonary tuberculosis.

NCT ID: NCT01693224 Active, not recruiting - Tuberculosis Clinical Trials

Feasibility of a Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in South Africa

Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults. A secondary study objective is to evaluate the accuracy and diagnostic yield of the Cepheid Xpert MTB/Rif test in detecting tuberculosis in the blood of HIV-infected adults.

NCT ID: NCT01691534 Active, not recruiting - Clinical trials for Pulmonary Tuberculosis

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

NC-003
Start date: September 2012
Phase: Phase 2
Study type: Interventional

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824 plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

NCT ID: NCT01690754 Completed - Tuberculosis Clinical Trials

Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

Start date: March 2011
Phase: N/A
Study type: Interventional

In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify. IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.

NCT ID: NCT01690403 Completed - Tuberculosis Clinical Trials

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients

Start date: December 2012
Phase: Phase 1
Study type: Interventional

Primary Objective: - To evaluate the effect of single and repeated administration of rifapentine given as daily or weekly regimen on steady-state pharmacokinetic parameters of efavirenz, emtricitabine and tenofovir given as a fixed dose combination (ATRIPLA™ ). Secondary Objective: - To evaluate the safety and tolerability of concomitant administration of rifapentine and ATRIPLA™ given to HIV+ patients