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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.

NCT ID: NCT02128139 Not yet recruiting - Clinical trials for Infective Endocarditis

Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study

EndoDev
Start date: June 2014
Phase: N/A
Study type: Observational

Introduction. Comprehensive data on infective endocarditis in developing countries are scarce. Objectives: Description of the characteristics (clinical and microbiological) and assessment of the outcomes of infective endocarditis in low-income countries. Methods : Prospective, Observational, Multicentre study. Inclusion criteria: patients aged over 1 year fulfilling the modified Duke criteria for infective endocarditis. Exclusion criteria: patient included during a previous infective endocarditis episode. Outcomes measures: Mortality at 6 months follow-up; mortality at 1 month follow-up; access to antibiotic treatment (modalities and duration), hospital length of stay and reason for discharge, and cardiac surgery when indicated. Duration: One year (June 2014- June 2015)

NCT ID: NCT02079961 Completed - Anemia Clinical Trials

Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply

Start date: January 2013
Phase: Phase 0
Study type: Interventional

The study on dairy value chains that will be conducted in Northern Senegal tests whether a health-related product (micro-fortified yogurt) targeted to children can be provided through the logistics of an existing value chain, and whether in return this can be leveraged to enhance the reliability of producers supply within this value chain. This study is conducted with a local milk factory, a recently established social enterprise, striving to produce dairy products with the milk collected from several hundred semi-nomadic small-scale producers in northern Senegal. This study tests: (i) whether the logistic created to collect milk in a remote area can be leveraged to deliver fortified yogurts to infants within its suppliers households; (ii) whether such products effectively help improve the nutritional status (anemia) of these children; and (iii) whether these health services encourage suppliers (and in particular women) to increase their milk delivery to the milk factory.

NCT ID: NCT02025868 Active, not recruiting - HIV Infection Clinical Trials

Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

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

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa. HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases: - First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers; - Second, a 48-week phase, during which: - Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement; - Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART. Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.

NCT ID: NCT01954264 Completed - Malaria Clinical Trials

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

Start date: October 19, 2013
Phase: N/A
Study type: Interventional

This study is designed to characterise P. falciparum transmission intensity in subjects aged ≥6 months and <10 years by measurement of P. falciparum parasite prevalence, and to estimate the use of malaria control interventions at some centres selected for the EPI-MAL-002 and EPI-MAL-003 studies in sub-Saharan Western Africa.

NCT ID: NCT01939457 Completed - Incomplete Abortion Clinical Trials

400mcg Sublingual Misoprostol as First Line Treatment

Start date: September 2011
Phase: N/A
Study type: Interventional

Women presenting with incomplete abortion and eligible for treatment with misoprostol were offered 400mcg sublingual misoprostol for treatment. Based on existing literature, the study hypothesises that women can successfully be treated with misoprostol alone as first line treatment.

NCT ID: NCT01905059 Completed - HIV Infection Clinical Trials

Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa

MOBIDIP
Start date: February 2014
Phase: Phase 3
Study type: Interventional

Multicenter, randomized, superiority trial to evaluate efficacy of a mono or bi-therapy of protease inhibitors with or without lamivudine over a period of 96 weeks. The primary outcome will be the failure rate at 96 weeks. This study will include 260 participants, former participants of the 2LADY trial. It will be carried out in Yaoundé, Bobo Dioulasso and Dakar.

NCT ID: NCT01854632 Completed - Influenza Clinical Trials

Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal

Start date: May 2013
Phase: Phase 3
Study type: Interventional

This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influenza vaccine.