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Malaria, Vivax clinical trials

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NCT ID: NCT01625871 Completed - Vivax Malaria Clinical Trials

Artemether/Lumefantrine and Vivax Malaria

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

The cure rate of artemether/lumefantrine in the treatment of vivax malaria.

NCT ID: NCT01546961 Completed - Vivax Malaria Clinical Trials

Chloroquine Population Pharmacokinetics in Pre and Post-partum Women

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

For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body of evidence suggesting that pregnant women may require different doses of drugs, including antimalarials due to the physiological changes of pregnancy. It is important that any drug used in pregnant women it is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same woman post-partum is required as a control.

NCT ID: NCT01524341 Completed - Malaria Clinical Trials

Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

Start date: January 2012
Phase: Phase 2
Study type: Interventional

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day

NCT ID: NCT01376167 Completed - Malaria, Vivax Clinical Trials

Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse

Start date: April 24, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax Malaria.

NCT ID: NCT01288820 Completed - Vivax Malaria Clinical Trials

Study of ACTs Plus Primaquine for Uncomplicated Plasmodium Vivax Malaria

ACTPQ
Start date: January 2011
Phase: Phase 3
Study type: Interventional

This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.

NCT ID: NCT01218932 Completed - Vivax Malaria Clinical Trials

Pharmacokinetic Study of Primaquine and Chloroquine in Healthy Subjects

PQCQ
Start date: October 2010
Phase: Phase 1
Study type: Interventional

This is a standard pharmacokinetic interaction study. Subjects will be randomized to be either group A or B. Group A. Subjects will have 3 hospitalizations to complete. Each hospitalization will be about 12-24 hours depends on each regimen. Subjects in A group who receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2 of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1 week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third admission (visit 4) after 8 weeks wash out period. Subjects in B group who receive regimen 1 of primaquine (PQ) will receive regimen 2 of chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of primaquine and chloroquine combination (PQ and CQ)on third admission(visit 4) with 8 week wash out period in between.

NCT ID: NCT01213966 Completed - Malaria, Falciparum Clinical Trials

Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection

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

A Phase IIa Exploratory, Open label, Single Dose Regimen, Multiple Dose Testing Clinical Study to Assess the Preliminary Efficacy, Tolerability and Pharmacokinetics of OZ439 in adult patients with acute, uncomplicated Plasmodium falciparum or vivax malaria mono-infection.

NCT ID: NCT01178021 Completed - Vivax Malaria Clinical Trials

Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan

VRA
Start date: August 2009
Phase: Phase 4
Study type: Interventional

This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine

NCT ID: NCT01083095 Completed - Malaria, Vivax Clinical Trials

Establishment of a Sporozoite Challenge Model for Plasmodium Vivax in Human Volunteers

ChallengeII
Start date: January 2005
Phase: Phase 0
Study type: Interventional

A clinical trial aimed to standardize a vivax sporozoite infection model in human volunteers was conducted at the Malaria Vaccine and Drug Development Center (MVDC) in collaboration with the Immunology Institute at Valle State University and the Fundación Clínica Valle del Lili (FCVL) in Cali, Colombia. The primary objective was to determine if naïve human volunteers could be safely and reproducibly infected by the bite of An. albimanus mosquitoes carrying P. vivax sporozoites in their salivary glands and a secondary objective consisted in determining the minimal number of infected mosquitoes required to infect all volunteers, with a reproducible pre-patent period. The trial was divided into two steps: Step A directed to obtain human blood infected with P.vivax parasite used to infect anopheles mosquitoes and Step B to produce P. vivax sporozoites in Anopheles mosquitoes to determine the dose response of naive human volunteers exposed to 3 +/- 1, 6 +/- 1 y 9 +/- 1 mosquitoes bites. A total of 15 samples of P. vivax infected donors were used to infect different batches of mosquitoes.

NCT ID: NCT01081847 Completed - Malaria, Vivax Clinical Trials

Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants

Fase1B
Start date: July 2005
Phase: Phase 1
Study type: Interventional

This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated in two adjuvants Montanide ISA 720 and Montanide ISA 51. The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of these peptides formulated in the two adjuvants We recruited 40 healthy men and women volunteers from Cali, Colombia, a city non-endemic for malaria. Volunteers were 19--41 years of age and had no history of malaria. During a period of three months a total of 100 volunteers were assessed for eligibility criteria in order to select a total of 40 volunteers willing to participate in the clinical trial. By consecutive allocation, eight participants were allocated to each of the five experimental groups (A--E): four groups (A--D) were immunized with the vaccine formulations at two different dose concentrations and formulated in two different adjuvants. A control group (E) was injected with placebo (saline solution)