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NCT ID: NCT02207816 Completed - Malaria Clinical Trials

An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

Start date: September 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.

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: NCT02192892 Completed - Malnutrition Clinical Trials

Acceptability Among Children and Caregivers of Amylase Porridges

AMY-01
Start date: June 2014
Phase: N/A
Study type: Interventional

Addition of α-amylase is considered as one of most effective solution to improve energy density of cereal based porridges (WHO, 2008). By adding α-amylase, the viscosity of porridges will be decreased while keeping dry matter content constant. Potential positive impact is to significantly improve efficiency of WFP nutritional programmes targeting vulnerable groups suffering from acute malnutrition. The acceptance of porridges made with α-amylase is tested compared to porridges made without α-amylase among 12-36 months old children and their caregivers. Acceptance is measured based on energy intake. The porridges tested consist of fortified blended Supercereal (12- <24 months) and Supercereal-Plus (24-36 months) based on Corn Soy Blend (CSB) extruded or drum dried, Wheat Soy Blend (WSB), Rice Soy Blend (RSB), all with and without α-amylase, or a commercial porridge, or eeZee bar.

NCT ID: NCT02174900 Completed - Malaria Clinical Trials

Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.

NCT ID: NCT02151578 Completed - Malaria Clinical Trials

Home Management of Malaria and Pneumonia

HMM/P
Start date: January 2009
Phase: Phase 4
Study type: Interventional

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

NCT ID: NCT02150993 Completed - HIV-2 Infection Clinical Trials

First-Line Treatment for HIV-2

FIT-2
Start date: January 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo). ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks. The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2 infected adult patients, in West Africa. A treatment will be considered as effective if more than 55% of patients in that arm attain "global success" at 96 weeks.

NCT ID: NCT02136966 Completed - Growth Failure Clinical Trials

Joint Infant and Young Child Nutrition Program and Malnutrition Prevention

Start date: November 2014
Phase: N/A
Study type: Interventional

Study title: Joint Infant and young children nutrition program in Burkina Faso: Impact evaluation Hypothesis: The fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children. Objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.

NCT ID: NCT02083380 Completed - Clinical trials for Uncomplicated Plasmodium Falciparum Malaria

Phase IIb Study to Investigate the Efficacy of OZ439 & Piperaquine Phosphate Co-administered to Adults & Children With Uncomplicated Plasmodium Falciparum.

Start date: July 2014
Phase: Phase 2/Phase 3
Study type: Interventional

A randomised, double-blind single-dose (loose combination) study in patients with uncomplicated Plasmodium falciparum malaria. The study will test for efficacy/futility through analyses, using Bayesian methodology. Adults and children will be included through progressive step-down in age following safety analyses. This study investigates the efficacy exposure-response of OZ439/PQP combination in the target populations and if it meets its efficacy objectives, will inform dose setting for Phase III studies.

NCT ID: NCT02071563 Completed - Child Malnutrition Clinical Trials

Effectiveness and Cost-Effectiveness of Four Formulations of Food Supplements for the Prevention of Wasting and Stunting in Burkina Faso

FAQR-Burkina
Start date: March 2014
Phase: N/A
Study type: Interventional

This research will serve as a follow-up on the review of Title II commodities performed by the Food Aid Quality Review at Tufts University in October 2011. The study in Burkina Faso will test the relative effectiveness and cost effectiveness of four supplementary foods in the prevention of MAM and stunting in normal programmatic settings. The aims of this study are to: 1. To compare the effectiveness of four alternative supplementary food commodities in preventing stunting and wasting, and promoting linear growth in children 6 - 23 months in the context of a preventive supplementary feeding program in Burkina Faso. 2. To estimate the relative cost of implementing the supplementary feeding program using each commodity 3. To estimate the relative cost/effectiveness of implementing the program using each commodity.

NCT ID: NCT02025868 Active, not recruiting - HIV Infection Clinical Trials

Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

THILAO
Start date: March 2013
Phase: Phase 2
Study type: Interventional

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa. HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases: - First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers; - Second, a 48-week phase, during which: - Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement; - Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART. Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.