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Malaria clinical trials

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NCT ID: NCT01746199 Completed - HIV Infection Clinical Trials

Efficacy of Antifolates Against Malaria in HIV-infected Pregnant Women and the Emergence of Induced Resistance in Plasmodium Falciparum

MACOMBA
Start date: December 2013
Phase: Phase 3
Study type: Interventional

Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging results in preventing malaria in pregnant women. However, these results must be confirmed by randomized trials, particularly in pregnant women. The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM), administered once daily with IPT-SP (3 curative doses spaced one month) on placental parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350 cells/mm3. The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP for placental parasitaemia. This might be due to the higher plasma concentration of cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count. In this study, the investigators will also test the hypothesis that the strains of Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance markers.

NCT ID: NCT01743820 Completed - Malaria Clinical Trials

Phase2a Primaquine Dose Escalation Study

Start date: September 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against P.falciparum among adult glucose-6-phosphate dehydrogenase (G6PD)-normal malaria patients.

NCT ID: NCT01743417 Completed - Malaria Clinical Trials

Computerized Cognitive Rehabilitation in Children After Severe Malaria

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

Brain training exercises will be provided to children who survived an episode of severe malaria. These children will be given assessments for cognition, behaviour and executive functions before and after the brain training exercises.

NCT ID: NCT01739036 Completed - Clinical trials for Plasmodium Falciparum Malaria

A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches Using the ChAd63 and MVA Vectors Encoding the Antigens ME-TRAP, CS and AMA1

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, multi-centre phase I/IIa sporozoite-challenge trial to assess the safety, immunogenicity and efficacy of two combination ChAd63-MVA heterologous prime-boost vaccination regimens. All volunteers recruited will be healthy, malaria naïve adults aged between 18 and 45 years. To determine the efficacy of each of two combinations of heterologous prime-boost immunisation strategies: 1. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS 2. ChAd63-MVA ME-TRAP combined with ChAd63-MVA CS and ChAd63-MVA AMA1 The study will be conducted at the University of Oxford's Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Oxford, UK and the Wellcome Trust Clinical Research Facility in Southampton, UK. The malaria challenge will take place at the insectary at Imperial College (Infection and Immunity Section) in London, UK.

NCT ID: NCT01736319 Completed - Clinical trials for Plasmodium Falciparum Malaria

Artemisinin-resistant Malaria in Cambodia

Start date: June 26, 2012
Phase:
Study type: Observational

Background: - Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria. ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of Cambodia, but not yet in other parts of the country. This has been shown by treating patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance. Researchers want to study how effective ACTs are in different regions of Cambodia. This study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has become. Objectives: - To compare the prevalence of ACT-resistant malaria in western, northern and eastern Cambodia. Eligibility: - Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days. Design: - Participants will be recruited from clinics and hospitals in three Cambodian provinces. - Participants will be informed about the study and their consent to participate in the study will be obtained. - A venous blood sample will be obtained from patients before treatment and used for laboratory experiments to measure parasite and patient factors that might affect the parasite clearance rate. - Participants with malaria will be treated with dihydroartemisinin-piperaquine (DHA-PPQ), the standard first-line treatment for malaria in Cambodia. - Treatment will be monitored with frequent blood samples obtained from a finger prick. The amount of malaria parasites in each blood sample will be counted and followed until they are no longer detectable. - Participants will have weekly follow-up visits for up to 9 weeks. Finger-prick blood samples will be taken at each visit to see if the parasites reappear after treatment with ACT.

NCT ID: NCT01728701 Completed - Malaria Clinical Trials

Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

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

The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).

NCT ID: NCT01722734 Completed - Malaria Clinical Trials

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

PACT
Start date: June 2011
Phase: N/A
Study type: Interventional

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system. Study hypothesis: text message reminders increase adherence

NCT ID: NCT01717885 Completed - HIV Clinical Trials

Antimalarial Pharmacology in Children and Pregnant Women in Uganda

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

The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will: 1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and 2. Evaluate the impact of age and pregnancy on the PK exposure of AL.

NCT ID: NCT01716260 Completed - Vivax Malaria Clinical Trials

Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

Start date: January 2013
Phase: N/A
Study type: Observational

This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone. This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.

NCT ID: NCT01713621 Completed - Malaria Clinical Trials

OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation

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

This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based dosing. The adaptive investigation of a range of doses will provide the best chance of accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on parasitaemia will be investigated.