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NCT ID: NCT02661464 Terminated - Clinical trials for Hemorrhagic Fever, Ebola

Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

Start date: May 31, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.

NCT ID: NCT02497612 Terminated - Clinical trials for Plasmodium Falciparum Infection

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FALCI
Start date: July 25, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

NCT ID: NCT01923311 Terminated - HIV Infections Clinical Trials

Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

Start date: August 26, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age. The study consists of 2 parts: Part A and Part B. Part A will enroll participants with suppressed viremia (HIV-1 RNA < 50 copies/mL) or failing a current antiretroviral (ARV) regimen (HIV-1 RNA > 1,000 copies/mL only for participants in Cohort 2, Part A) to evaluate the steady state PK and confirm the dose of EVG. Part B will enroll participants who are failing a current ARV regimen (HIV-1 RNA > 1,000 copies/mL) to evaluate the safety, tolerability, and antiviral activity of EVG. The study consists of 4 age cohorts with each cohort including 2 parts (Part A and Part B) with the exception of the adolescent age cohort (Cohort 1: 12 to < 18 years old) containing Part B only.

NCT ID: NCT01862783 Terminated - Malaria Clinical Trials

Collection of Biological Material From Pregnant Women in a Malarial Region

Start date: February 10, 2013
Phase:
Study type: Observational

Background: - Malaria is a disease caused by a parasite that infects the blood. It affects millions of people every year and frequently harms or kills pregnant woman and infants. Researchers are looking for treatments that may help pregnant women in areas of the world where malaria is common. To do so, they want to collect blood and other samples from pregnant women in south-central Uganda. They will also collect samples from newborn babies if the mother agrees to it. Objectives: - To collect biological material such as blood samples from pregnant women and newborns. Eligibility: - Women between 14 and 45 years of age who are pregnant or are in labor. - Participants will be from the Kalisizio area of south-central Uganda. Design: - Women who are pregnant will provide blood and urine samples. - Women who are in labor will allow researchers to collect samples from their baby after the delivery. Samples will be taken of placenta tissue and umbilical cord blood. The baby will also be weighed and measured. Researchers will look at the baby's physical appearance and muscle strength. - Treatment will not be offered as part of this study.

NCT ID: NCT01728961 Terminated - Malaria Clinical Trials

Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria. The brand of AL used in this study is Coartem® Dispersible. This study will compare the blood levels of AL in co-infected children who already take NVP prescribed by their doctor with the co-infected children who do not take anti HIV medicines because they do not meet national guidelines to start them. The study will also assess the safety of using both medications (AL and NVP) in children.

NCT ID: NCT01688674 Terminated - Clinical trials for Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.

Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia

Start date: February 2012
Phase: N/A
Study type: Interventional

NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit- Mulago Hospital. ALTERNATE HYPOTHESIS • Use of two hourly 10% dextrose boluses increases the incidence of hypoglycemia by 30% compared to 10% dextrose infusion by burettes among preterms admitted to Special Care Unit in the first 72 hours of admission.

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: NCT01103713 Terminated - Clinical trials for Asymptomatic Parasitemia In Pregnancy

Evaluate Parasitological Clearance Rates And Pharmacokinetics Of The Combination Of Azithromycin And Chloroquine In Asymptomatic Pregnant Women With Falciparum Parasitemia In Africa

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

The study will be conducted in asymptomatic pregnant women with P. falciparum parasitemia. The subjects will be given 3 day dosing regiment of the fixed-dose combination of Azithromycin and Chloroquine. Parasitological clearance rate with polymerase chain reaction data will be evaluated on Day 28 as primary endpoint.

NCT ID: NCT01103063 Terminated - Clinical trials for Intermittent Preventive Treatment In Pregnancy (IPTp)

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.

NCT ID: NCT00855062 Terminated - HIV Infections Clinical Trials

Minocycline for HIV+ Cognitive Impairment in Uganda

Start date: April 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (HIV)-associated cognitive impairment in Uganda. Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 (CD4) Count in the 251-350 Range - Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects) - Arm 2: Matching placebo orally every 12 hours (50 subjects) Primary Objective: · To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline Secondary Objectives: - To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment - To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment - To examine whether minocycline treatment for 24 weeks improves functional impairment