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NCT ID: NCT01161160 Completed - Influenza Clinical Trials

Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

Start date: July 1, 2010
Phase: Phase 2
Study type: Interventional

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

NCT ID: NCT01160120 Completed - HIV Clinical Trials

Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz

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

The purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

NCT ID: NCT01159275 Completed - HIV-1 Infections Clinical Trials

Lopinavir (LPV) Dose Reduction

Start date: July 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

NCT ID: NCT01159223 Completed - HIV Infections Clinical Trials

Low Dose Atazanavir/r Versus Standard Dose Atazanavir/r (LASA)

Start date: May 2011
Phase: Phase 4
Study type: Interventional

This study will compare the efficacy and safety of ATV/r at either 200/100 mg or 300/100mg given daily in Thai patients in combination with 2NRTIs.

NCT ID: NCT01159132 Completed - HIV Infections Clinical Trials

Pharmacokinetics of Low Dose Raltegravir

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

The purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.

NCT ID: NCT01156896 Completed - Iron Deficiency Clinical Trials

Malaria and the Safety of Iron Supplements and Iron Fortification

MIA
Start date: July 2010
Phase: N/A
Study type: Interventional

The primary study hypothesis of the investigators is that administration of an iron supplement between meals at a dose like that used in the Pemba trial (~1 mg Fe/kg) during P. falciparum parasitemia will increase plasma non-transferrin-bound iron. A key subsidiary hypothesis is that iron administered with meals in amounts used in food fortification (~0.1 mg Fe/kg) will not produce plasma non-transferrin-bound iron. This research will be carried out at the Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand. The studies are intended to help understand how giving iron and folic acid to preschool children in Pemba, Zanzibar, Tanzania, (the "Pemba trial") in the doses recommended by the World Health Organization, could have resulted in an increase in hospitalizations and deaths. The investigators will examine the most likely explanation, that the dose of iron supplements used in the Pemba trial produced iron in the blood not bound to the usual carrier for iron (a protein called "transferrin"), that is called "non-transferrin-bound iron", abbreviated as NTBI. In children with malaria, this NTBI might favor the growth of malarial parasites or other causes of infection. At present, no studies have been carried out to see if NTBI is present after giving iron to patients with malaria. Using non-radioactive forms of iron (called "stable isotopes"), the investigators will study iron absorption and NTBI after giving a single dose of iron (like that used in the Pemba trial) one day after treatment for malaria has been started, while patients still have malaria parasites in the blood, and then again two weeks later, after the malaria has been cured. The investigators will study adults admitted to the Hospital for Tropical Diseases in Bangkok, Thailand, with malaria. For reasons of safety, the investigators have chosen to study adults in the hospital rather than children living in an area like Pemba but the results should also apply to children. The outcome of this research will help us design ways of safely giving iron in malarious areas to adults and children to prevent or treat iron deficiency.

NCT ID: NCT01156038 Completed - Normal Clinical Trials

Atopy Patch Test in Normal Population : Pilot Study

Start date: February 2010
Phase: Phase 1
Study type: Interventional

Atopy patch test in normal population

NCT ID: NCT01154088 Completed - Clinical trials for Infections, Meningococcal

Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

Start date: August 27, 2010
Phase: Phase 3
Study type: Interventional

The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.

NCT ID: NCT01150448 Completed - Schizophrenia Clinical Trials

A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia

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

The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the pharmacokinetics of paliperidone following fixed multiple intramuscular injections of paliperidone palmitate 150 mg eq.

NCT ID: NCT01146652 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Start date: June 21, 2010
Phase: Phase 3
Study type: Interventional

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.