Clinical Trials Logo

Filter by:
NCT ID: NCT02305927 Completed - HIV Clinical Trials

Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health

ToV5
Start date: June 15, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).

NCT ID: NCT02288637 Completed - Malaria Clinical Trials

Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product

Start date: September 2014
Phase: N/A
Study type: Interventional

The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist. The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.

NCT ID: NCT02281578 Completed - HIV Clinical Trials

Community-based Combination HIV Prevention in Tanzanian Women

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

The Phase II trial will assess the feasibility, acceptance, safety, pathways, and initial effectiveness of a community-based combination HIV prevention intervention among bar-based female sex workers in Iringa, Tanzania. Results will inform an appropriately powered Phase III RCT as warranted.

NCT ID: NCT02259166 Completed - Anemia Clinical Trials

Enhanced Homestead Food Production Plus+ Program in the Lake Zone, Tanzania

Start date: June 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an impact on child growth, infant and young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria prevention, food security and women's empowerment.

NCT ID: NCT02229474 Completed - Dementia Clinical Trials

IDEA Study Cognitive Stimulation Therapy (CST) Trial in Tanzania

IDEA
Start date: September 2014
Phase: N/A
Study type: Interventional

This trials of cognitive stimulation therapy (CST) in Tanzania is part of the larger Identification and Intervention for Dementia in Elderly Africans (IDEA) study. The overall aim of the IDEA study is to set up and evaluate sustainable programmes to facilitate diagnosis of, and therapy for, people with dementia led by local communities in sub-Saharan Africa. We aim seek to improve quality of life for people with dementia and their caregivers. Within this trial of CST, we hypothesise that CST can significantly improve the quality of people with dementia and their carers living in Africa

NCT ID: NCT02225769 Completed - Clinical trials for Acute Febrile Illness

Electronic Algorithms Based on Host Biomarkers to Manage Febrile Children

e-POCT
Start date: December 2014
Phase: N/A
Study type: Interventional

Health professionals in developing countries have limited ability to identify children at risk of dying and those in need of antibiotics. The main reasons are limited clinical skills and time, unavailability of diagnostic tests (laboratory or x-ray) and non-adherence to practice guidelines. Child mortality is therefore higher than it should be. Etiological diagnostic tests (detecting microorganisms) may not always help since the distinction between infection and disease and between mild or severe disease is not straightforward. Overprescription of antibiotics is therefore widespread and leads to the development of drug resistance. To address these challenges, decision charts for the management of febrile illness will be developed and include i) few clinical parameters simple to assess, and ii) POCTs results based on specific host markers that can discriminate between mild and severe disease, pneumonia and upper respiratory tract infections, and unspecific fevers of bacterial and of viral origin. This algorithm combining clinical and bedside laboratory tests will be built on an electronic support (android tablet). The first objective of the study is to assess the safety of new electronic decision trees that integrate simple clinical assessment and POCTs results (oxygen saturation and a combination of specific biomarkers of inflammation) as a triage tool to decide on admitting febrile children; the second objective is to assess the usefulness and safety of new electronic decision trees that integrate simple clinical assessment and POCT results (a combination of specific biomarkers of inflammation) as decision-making tool to prescribe antibiotics to non-severe febrile children. The development of such a tool will decrease mortality due to delayed admission, At the same time, it will decrease irrational use of antibiotics, and hence drug pressure and emergence of drug resistance, which represents one of the most important public health threat our world is facing today. This project has the potential of huge applicability since it is specifically designed for end-users with limited medical skills and low resources, as it is the case in most areas of developing countries.

NCT ID: NCT02207816 Completed - Malaria Clinical Trials

An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

Start date: September 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.

NCT ID: NCT02193776 Completed - Tuberculosis Clinical Trials

A Phase 2 to Evaluate the Efficacy, Safety and Tolerability of Combinations of Bedaquiline, Moxifloxacin, PA-824 and Pyrazinamide in Adult Subjects With Drug-Sensitive or Multi Drug-Resistant Pulmonary Tuberculosis.

NC-005
Start date: October 23, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the mycobactericidal activity of combinations of bedaquiline (J), moxifloxacin (M), PA-824 (Pa) and pyrazinamide (Z) regimens during 8 weeks of treatment.

NCT ID: NCT02191683 Completed - Epigenetics Clinical Trials

Foetal Exposure and Epidemiological Transition: Role of Anaemia in Early Life for Non-communicable Diseases Later

FOETALforNCD
Start date: July 2014
Phase:
Study type: Observational [Patient Registry]

Study Hypotheses: 1. Anaemia, which is frequent before conception as well as during early pregnancy, affects metabolism and foetal growth trajectories, influencing the risk of NCDs in the offspring. 2. Anaemia from conception till end of 2nd trimester is most detrimental for foetal and newborns' health, compared to 3rd trimester anaemia. 3. Anaemia from conception till end of 2nd trimester affects foetal and newborns health through poor placental development reflected in increased villous branching and changed umbilical and uterine blood flow. 4. Anaemia in early pregnancy disrupts the vascular endothelial growth factor A (VEGF-A)/placental growth factor (PlGF) balance and the insulin-like growth factor (IGF) axis resulting in poor placental development, and poor health of newborns. This may be reflected in specific methylation patterns. 5. Anaemia's impact on the risk for NCDs in the offspring may be mediated via epigenetic mechanisms, including changes in DNA methylation patterns.

NCT ID: NCT02176772 Completed - Tuberculosis Clinical Trials

Iron Absorption and Utilization During Tuberculosis and After Treatment

Start date: April 2015
Phase: N/A
Study type: Observational

Background: The disease burden of tuberculosis (TB), second only to HIV/AIDS among infectious diseases, is a major public health problem in developing countries. Accumulating evidence suggests that iron status is a primary determinant of TB progression. Anaemia is prevalent in patients with TB, particularly in sub-Saharan Africa, and associated with increased mortality. Anaemia in TB may be due to inflammation, dietary iron deficiency, or both, and distinguishing among these aetiologies is difficult. Iron supplementation is commonly used to treat anaemia in TB patients, but may be unnecessary if inflammation is the cause. Body iron sequestered by TB inflammation can be mobilized during treatment and used to correct the anaemia. Moreover, supplemental iron may be retained within macrophages, potentially increasing susceptibility to TB and leading to a poorer clinical outcome. Thus, better understanding of iron metabolism during TB and the aetiology of TB-related anaemia would clarify the potential role of iron in pathogenesis and optimal management of the disease. The investigators hypothesize that: a) TB will increase circulating hepcidin and thereby impair dietary iron absorption and systemic utilization of iron, resulting in iron sequestration and anaemia; b) TB treatment and resolution of inflammation over 6 months will decrease circulating hepcidin, correcting these impairments and improving iron status and hemoglobin; c) the majority of iron utilized to replenish hemoglobin during recovery from TB will come from mobilization of sequestered iron stores rather than from iron absorption. Objectives: Use iron stable isotopes to characterize iron balance over six months of TB treatment, and specifically to: a) quantify oral and intravenous iron incorporation (oral absorption and systemic iron utilization) at three time points during TB treatment (acute disease, after the intensive treatment phase and at completion of the continuation treatment phase); and b) determine the effect of treatment on iron mobilization from stores to replenish hemoglobin. Methods/Subjects: Using a triple stable-isotope technique, iron absorption from labelled test meals (57Fe) and systemic iron utilization after labelled intravenous doses (54Fe, 58Fe) will be determined in 18 Tanzanian subjects with newly diagnosed pulmonary TB. The subjects will be studied at three time points (i) the day after TB diagnosis while infected, (ii) after 8 weeks of intensive phase treatment, and (iii) after another 16 weeks of continuation phase treatment. Iron status, hemoglobin, hepcidin and inflammation indexes will be measured at each time point. Isotope enrichment during the two treatment phases will be measured to estimate the relative rates of iron absorption and mobilization from stores during the intensive and continuation phases to determine the relative contributions of iron absorption and iron mobilization from stores during TB treatment and recovery. Outcome: These studies will provide important new insights into the aetiology of anaemia and iron metabolism in TB patients. The results will provide essential data for evidence-based recommendations on the timing, administration route and efficacy of iron therapy in patients with TB, making possible, a safer and more effective treatment of anaemia in TB while decreasing morbidity and mortality from the disease.