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NCT ID: NCT01557803 Completed - Clinical trials for Opportunistic Infections

Prediction and Pathogenesis of the Immune Reconstitution Inflammatory Syndrome

IRIS
Start date: January 2012
Phase: N/A
Study type: Observational

The objective of this project is to determine clinical and biological predictors of Immune Reconstitution Inflammatory Syndrome (IRIS) occurrence in HIV infected patients who are started on antiretroviral therapy (ART), and to obtain more insight into the pathogenesis of this syndrome. The investigators will prospectively study HIV infected patients in Sub Saharan Africa who will be initiated on ART and are at risk to develop IRIS in all its different appearances. In these patients, the investigators will assess the value of clinical features and plasma biomarkers to predict IRIS, and the investigators will obtain insight into which inflammatory pathways become activated during IRIS. This project will provide novel knowledge about this clinically highly relevant healthcare problem in a resource poor setting, namely in Lambaréné, Gabon, in the Central African rainforest belt. In Gabon little research has been done in the field of HIV. The epidemiological pattern of IRIS in Gabon will be described. Promising putative plasma biomarkers will be validated for their use in daily practice.

NCT ID: NCT01445938 Terminated - Malaria Clinical Trials

Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Start date: October 2011
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria Secondary Objectives: - To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs) - To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria - To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A

NCT ID: NCT01417988 Terminated - Tuberculosis Clinical Trials

Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment

PrOMPT
Start date: August 2011
Phase: Phase 4
Study type: Interventional

This study investigates the prevention of early mortality in patients initiating antiretroviral therapy (ART) in sub-Saharan Africa where 79% of the co-infected cases of TB reside. Many published studies have shown a surprisingly high proportion of all patients initiated on ART dying within 6 months (8-26%) with increasing risk with decreasing CD4 T cell count. The majority (median 70%) occur in the first 3 months with the greatest proportion of deaths due to previously undiagnosed tuberculosis (TB). The investigators will enroll patients from 4 geographically diverse countries (Gabon, Mozambique, South Africa, and Uganda) in a randomized open label clinical trial targeting a population of people with high mortality risk; patients with CD4 T cell count < 50 cells/μl and body mass index (BMI) < 18 kg/m2. Severely immunocompromised patients with low BMI in the intervention arm will receive presumptive anti-TB 4-drug chemotherapy and subsequently initiate ART within 2 weeks compared to ART alone. The main objective is to measure and compare early mortality in the group presumptively treated for TB in addition to ART. Other sub-objectives are to determine the predictors of early mortality and the causes of death by autopsy (traditional and verbal), to determine if presumptive anti-TB treatment affects viral suppression with ART, and to assess incidence rates and characterize drug toxicity in patients dually treated. Because of the high rates of TB co-infection in sub-Saharan Africa in the HIV-infected, the investigators expect that patients presumptively treated for TB in addition to HIV will have a lower mortality rate than patients receiving ART only. This trial is expected to be of great public health benefit and generalisability.

NCT ID: NCT01361269 Not yet recruiting - Malaria Clinical Trials

Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria

Start date: June 2011
Phase: Phase 2
Study type: Interventional

Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.

NCT ID: NCT01192802 Completed - Intestinal Diseases Clinical Trials

Efficacy of Albendazole to Treat Intestinal Helminths and Its Effect on Gut Microflora

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Albendazole is a main anti-helminth, however there is a lack of data regarding its efficacy in the school children population. The aim of this study is to evaluate the efficacy of the albendazole one versus two and three doses, in school children infected with intestinal helminth.

NCT ID: NCT01190202 Completed - Malaria Clinical Trials

Epidemiology Study of Malaria Transmission Intensity in Africa

Start date: March 14, 2011
Phase: N/A
Study type: Interventional

The aim of this epidemiology study is to characterize in a standardized way malaria transmission intensity at the clinical trial centers participating in study 110021 (NCT00866619).

NCT ID: NCT01132248 Completed - Clinical trials for Urinary Schistosomiasis

Activity of Mefloquine Against Urinary Schistosomiasis

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

Urinary schistosomiasis is a debilitating disease in Central Africa and pregnant women are frequently suffering from this condition. Mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. The investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.

NCT ID: NCT01030458 Completed - Blood Pressure Clinical Trials

Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial

NOAAH
Start date: September 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

NCT ID: NCT00988507 Terminated - Clinical trials for Plasmodium Falciparum Infection

Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FARM
Start date: October 2009
Phase: Phase 2
Study type: Interventional

Primary objective: To assess the Day 28 efficacy defined as the percentage of patients with no parasitic recrudescence, of 3 treatment groups - 3 dose levels of ferroquine associated with artesunate - for a 3-day treatment. Secondary objectives: - To assess the efficacy of ferroquine at one dose level alone for a 3-day treatment. - To assess the clinical safety of 4 treatment groups - 3 dose levels of ferroquine associated with artesunate and one dose level of ferroquine alone. - To assess pharmacokinetics parameters of ferroquine and its metabolites along sparse sampling schedules.

NCT ID: NCT00866619 Completed - Malaria Clinical Trials

Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa

Start date: March 27, 2009
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.