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NCT ID: NCT02199951 Recruiting - Malaria Clinical Trials

Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

Start date: September 2013
Phase: Phase 4
Study type: Observational

WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the African market and will be used by the public health care system. The collection of safety data and risk evaluation through observational data are critical in order to assess risk/benefit profile of each ACT through its life cycle and providing information on the best use. Additionally there is need to assess the impact of the introduction of a new ACT in the evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries. This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo), Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as first-line treatment of uncomplicated malaria an objective to evaluate the safety of Eurartesim® when used under usual conditions in 10,000 patients. Patients > 6 months and 5 kg except pregnant women will be enrolled and Eurartesim® administered as a single daily dose regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to assess recovery and any adverse events.

NCT ID: NCT02140255 Recruiting - HIV Infection Clinical Trials

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Start date: January 23, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

NCT ID: NCT01906788 Recruiting - Clinical trials for Malaria Transmission

The Optimal Timing Of Primaquine To Prevent Malaria Transmission After Artemisinin-Combination Therapy

Start date: May 2013
Phase: Phase 4
Study type: Interventional

The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"

NCT ID: NCT01746758 Recruiting - HIV Clinical Trials

Mobile Phone Text Messaging Referral

SMS4Health
Start date: August 2012
Phase: N/A
Study type: Interventional

The study hypothesis is that managed referral of patients at community level (from drug stores) increases uptake of reproductive health (RH) services at dispensary and health centre levels. The intervention is currently being implemented in 2 districts (Magu and Sengerema) in Mwanza Region on the northwest shore of Lake Victoria. It is nested within the IntHEC Community Randomised Trial which aims to evaluate the impact of a complex RH intervention on the uptake and integration of reproductive health services in 2 Regions in Tanzania (Mwanza and Iringa) and Niger (Say and Aguie) respectively. 18 wards per region were stratified according to geographical and economic criteria and randomly assigned to intervention or comparison wards. The SMS intervention is being implemented in 9 intervention wards in Mwanza Region only. 9 wards are followed for comparison.

NCT ID: NCT00474435 Recruiting - HIV Infections Clinical Trials

Pharmacokinetics of Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Tuberculosis

PETE
Start date: November 2008
Phase: Phase 2
Study type: Interventional

In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabine/tenofovir/efavirenz will be studied in HIV-positive patients with pulmonary tuberculosis (TB) who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen. It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication.

NCT ID: NCT00469651 Recruiting - Malaria Clinical Trials

Phase Ib Trial of MSP3 LSP in Children in Tanzania

MSP3TN
Start date: October 2007
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission. Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration. The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.

NCT ID: NCT00216333 Recruiting - Tuberculosis Clinical Trials

Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis

Start date: December 2003
Phase: Phase 4
Study type: Interventional

The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.

NCT ID: NCT00122746 Recruiting - Clinical trials for Cancer of the Cervix

Clinical and Experimental Studies to Improve Radiotherapy Outcome in AIDS Cancer Patients

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The researchers plan: - To undertake clinical studies of radiotherapy with or without the administration of the chemotherapeutic agent cisplatin, known to be a radiosensitizer; - To perform pre-clinical studies of the radiosensitivity of human fibroblasts and cervical cancer cell lines in culture, with or without the addition of various HIV proteins or protease inhibitors, in order to determine the extent of any cellular radiosensitizing properties of these molecules; - To develop strategies for sensitizing tumour cells to radiation, specifically by down-regulating specific viral proteins that are known to be factors associated with resistance to radiotherapy.