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NCT ID: NCT02485912 Completed - Ebola Virus Disease Clinical Trials

Evaluation of a New Ebola Vaccine Using a Short-interval Prime-boost Vaccination

Start date: July 2015
Phase: Phase 1
Study type: Interventional

This is a clinical trial in which healthy volunteers will be administered two experimental Ebola vaccines: ChAd3-EBO Z and MVA-EBO Z. Two groups of volunteers will be vaccinated with both vaccines one after the other in a prime/boost regimen. All ChAd3-EBO Z doses are 2.5 x 10^10 - 3.7 x 10^10 vp and all MVA-EBO Z doses are 1.0 x 10^8 pfu. All volunteers will receive a ChAd3-EBO Z priming vaccine and a MVA-EBO Z boosting vaccine 7 days later. The site of administration of the MVA-EBO Z vaccine differs between the two groups: Group 1 will receive the MVA-EBO Z vaccine in the same arm as the ChAd3-EBO Z vaccine. Group 2 will receive the MVA-EBO Z vaccine in the opposite arm from the ChAd3-EBO Z vaccine. The study will assess the safety of the vaccinations, and the immune responses to vaccination. Immune responses are measured by tests on blood samples. The ChAd3-EBO Z and MVA-EBO Z vaccines are called viral vectored vaccines. They are made from viruses which are modified so that they cannot multiply. The viruses have extra DNA in them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so that the immune system builds a response to Ebola without having been infected by it. Healthy volunteers will be recruited in Dakar, Senegal. The study will be funded by GSK.

NCT ID: NCT02485301 Completed - Virus Diseases Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults

Start date: July 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational ChAd3-EBO-Z vaccine to afford at least partial protection, all subjects in the study will receive the investigational ChAd3-EBO-Z vaccine. The subjects in the Group EBO-Z will receive the vaccine at Day 0 of the study, whereas the subjects in the Group Placebo/ EBO-Z will receive a placebo at Day 0 (as a control) and will receive the investigational ChAd3-EBO-Z vaccine at Month 6, provided that no safety concerns are raised. In addition, vaccinating all subjects in the study with the investigational ChAd3 EBO Z vaccine will allow an increase of the safety database of the investigational vaccine. In case the geographic range of Ebola virus Zaire (EBOV) transmission expands to encompass any of the regions where this trial is conducted, earlier administration of the investigational ChAd3-EBO-Z vaccine to the subjects in the Group Placebo/ EBO-Z will be considered in that region.

NCT ID: NCT02474303 Completed - HIV/AIDS Clinical Trials

Demonstration Project of PrEP Among Female Sex Workers in Dakar, Senegal

Start date: July 2015
Phase: N/A
Study type: Interventional

Recent breakthroughs in antiretroviral (ARV)-based prevention provide new opportunities to rethink HIV prevention and treatment strategies, especially for key populations such as Female Sex Workers (FSWs). Antiretroviral (ARV)-based prevention of HIV transmission has the potential to have a profound population-level impact on the course of the HIV/AIDS pandemic. Several recently completed randomized controlled trials of HIV Pre-exposure Prophylaxis (PrEP) have shown efficacy at reducing HIV acquisition in high-risk populations. How to translate these trial results into population-level effects is the next critical step. PrEP "demonstration" projects, in collaboration with local stakeholders and at sites of routine care for high-risk populations provide an opportunity to move promising research results into actual public health benefits. With these key features in mind, the investigators propose an HIV PrEP demonstration project in FSW in Dakar, Senegal, West Africa. The objective of the proposed demonstration project with Tenofovir DF/Emtricitabine (TDF/FTC) among Female Sex Workers (FSW) in Dakar Senegal is to build a sustainable HIV PrEP program for FSW in Dakar, Senegal while demonstrating the feasibility of providing daily oral PrEP with Truvada (TDF/FTC) for 12 months to the enrolled FSW at Ministry of Heath run clinics (Pikine, Mbao, Rufisque and Diamniadio Health Centers). Critical milestones for this demonstration project with be feasibility, uptake, acceptability, use of TDF/FTC PrEP and programmatic retention of FSWs in Dakar MoH clinics. The investigators have assembled an expert team from RARS,The University of Washington, and Westat that have had greater than 2 decades of collaboration on HIV related projects in FSWs in Senegal. The investigators expect the results of this project will show that Senegal provides a unique opportunity to assess acceptability, feasibility, uptake and effectiveness of oral HIV PrEP at reducing HIV transmission in a high-risk FSW population.

NCT ID: NCT02437955 Completed - Clinical trials for Anemia; Deficiency, Nutritional, With Poor Iron Absorption

Fe Absorption in Mother and Child Pairs From Wheat Fortified With Iron With and Without Phenolic Containing Beverages

Fe_Senegal
Start date: April 2015
Phase: N/A
Study type: Interventional

In Senegal, iron deficiency affects 39% of and 82% of women and children between 12 and 50 months indicating that iron deficiency is a major health problem. The government of Senegal has implemented a flour fortification program including iron and folate. Iron is a difficult mineral to add to foods efficiently due to its organoleptic properties and typical low bioavailability in man. The aim of this study is to determine iron absorption from fortified wheat flour consumed with a phenolic containing beverage in women and child pairs. The fortificants used will be Ferrous Fumarate and Ferrous Sulfate, and the effect of absorption inhibitors on the bioavailability from iron compounds not readily bioavailable is poorly investigated. The bioavailability of the different iron compounds will be determined using stable iron isotopes. Sixteen pairs of women and children (n=34, children between 3-6 years, women between 18-45y) will be selected for participation in the study. After a screening, each women and child will receive 4 test meals consisting of a bread roll fortified stable isotopes with and without the tisane beverage. The first two test meals will be consumed on consecutive days. Two weeks after the second test meal a blood sample will be taken from each women and child before the third meal administration. After the forth test meal administration, and again two weeks later, the last blood sampling will take place and the study will be conducted for the subjects (duration 30 days). The samples will be sent to Zurich on dry ice for analysis for the following parameters: isotopic composition, H pylori infection, B vitamin status, Vitamin A status. In all samples, hemoglobin and iron status as well as inflammation status (CRP) will be determined.

NCT ID: NCT02433743 Completed - Malnutrition Clinical Trials

Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA

PLWHA
Start date: October 2011
Phase: N/A
Study type: Interventional

A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group: n=32). Individual dietary intakes were measured and compared to the Recommended Dietary Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA), hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and after 9 weeks home-based follow up.

NCT ID: NCT02413905 Completed - Malnutrition Clinical Trials

Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Start date: January 2014
Phase: N/A
Study type: Observational

The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).

NCT ID: NCT02405013 Completed - Hepatitis C Clinical Trials

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

TAC
Start date: October 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment [SVR12]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa Secondary Objectives: 1. To estimate the study treatment SVR24 rate 2. To evaluate the clinical and biological tolerance of study treatment 3. To describe HCV kinetics under HCV treatment, and identify associated factors 4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients 5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24 6. To identify factors associated with SVR12 and SVR24 (including HIV status) 7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24) 8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon 9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.

NCT ID: NCT02180438 Completed - HIV-2 Infection Clinical Trials

An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal

Stribild HIV-2
Start date: September 2014
Phase: Phase 4
Study type: Interventional

There is a critical need for safe and effective antiretroviral treatment (ART) regimens for HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2 million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is frequent. Although an increasing body of evidence supports the potential utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to assess their effectiveness and they are not routinely available in resource-limited settings. These limitations present major challenges to HIV-2 treatment, particularly in the areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial of STRIBILD

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: NCT02129829 Completed - Clinical trials for Hepatocellular Carcinoma

PROLIFICA - West African Treatment Cohort for Hepatitis B

WATCH
Start date: October 2011
Phase:
Study type: Observational

The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps required to successfully treat patients with chronic hepatitis B virus infection to prevent cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B using a point of care test is feasible and effective. The second is to monitor linkage from screening into care. The third is to evaluate cheap non-invasive assessments to determine the need for treatment. The fourth is to determine what proportion of patients meet treatment eligibility criteria. The fifth step is to establish a treatment cohort which can be used to measure adherence to therapy and avoidance of HBV related complications. A parallel untreated cohort will be established to determine whether treatment criteria are relevant in this West African setting by monitoring for complications of HBV infection.