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NCT ID: NCT02410772 Completed - Tuberculosis Clinical Trials

TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

S31/A5349
Start date: January 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.

NCT ID: NCT02344290 Completed - HIV Infections Clinical Trials

Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

REPRIEVE
Start date: March 26, 2015
Phase: Phase 3
Study type: Interventional

People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART). The REPRIEVE trial consists of two parallel identical protocols: - REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided by the NIAID, and is conducted in U.S and select international sites (approximately 120 sites in 11 countries). - REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in Spain.

NCT ID: NCT02301520 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D, Iodine, and Lead Levels in Haitian Infants and Children.

Haiti
Start date: January 2015
Phase: N/A
Study type: Observational

Vitamin D deficiency is common worldwide, including in infants and children, and rickets remains a public health concern in many developing countries. The vitamin D status and prevalence of vitamin D deficiency in the Haitian population has not been studied. There is currently no approved point-of-care testing device for vitamin D deficiency. Iodine deficiency and resulting hypothyroidism is the leading cause of preventable neuro-developmental delay and cognitive impairment worldwide. Young infants and children are especially susceptible to sequelae of disruption in thyroid function given the dependence of the developing brain on sufficient levels of thyroid hormone. Perchlorate and thiocyanate have been described as potential environmental disrupters of thyroid function. Lead intoxication is a significant cause of disease throughout the world. Millions of people have suffered the effects of lead poisoning. Although most developed countries have taken drastic measures to limit the environmental lead levels, many countries in the developing world have not been able to address, or even assess, the problem. Our objectives are to study the following three components in 300 Haitian children between 9 months and 6 years of age in three different geographical areas of Haiti: 1) Vitamin D status and prevalence of rickets, environmental factors associated with low vitamin D levels, and the accuracy and efficacy of a vitamin D point-of-care testing (POCT) device for the screening of vitamin D insufficiency. 2) Iodine status and thyroid function, and environmental disruptors such as perchlorate and thiocyanate as potential risk factors for abnormal thyroid function. 3) Lead levels and the extent of childhood lead poisoning.

NCT ID: NCT02096250 Completed - Iron Deficiency Clinical Trials

Iron Absorption in Haiti

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

The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.

NCT ID: NCT02095613 Completed - HIV Clinical Trials

Tailored Nutrition and Food Security Interventions in Comprehensive HIV Care

Start date: May 2010
Phase: N/A
Study type: Interventional

The study hypothesizes that one form of food supplement to HIV-infected individuals in Haiti (ready-to-use-supplementary food) will result in improved HIV, nutrition and quality of life outcomes when compared to a second type of food supplement (corn-soy-blend) over the course of 12 months of food supplementation.

NCT ID: NCT01936831 Completed - Tuberculosis Clinical Trials

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

Start date: August 13, 2014
Phase: Phase 2
Study type: Interventional

Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does not work as well at fighting the bacteria. This study treated people with INH-resistant TB with different doses of INH to see if INH can still fight the bacteria if the dose is increased. We evaluated how well the drug works at higher doses for participants who have resistant TB as well as how well the drug works at regular doses for participants who have TB that is not resistant. The study also evaluated the safety and tolerability of the different doses of INH. Tolerability is how well people can put up with the side effects of a drug. Using increased doses of INH to treat TB that is resistant to INH is experimental and has not been approved by regulatory authorities. While there is some evidence that this approach will work, this has not yet been proven.

NCT ID: NCT01779011 Completed - Wounds and Injuries Clinical Trials

Monitoring and Treatment of Extremity Trauma for Mass Casualties in Difficult Contexts

SuTra²
Start date: January 2011
Phase: N/A
Study type: Observational

The prospective cohort study, SuTra2, assesses the functional and socio-economic status of patients who were operated on for a severe limb injury resulting in amputation or limb preservation 1 and 2 years after the 2010 Haiti earthquake.

NCT ID: NCT01641367 Completed - HIV-1 Infection Clinical Trials

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

MULTI-OCTAVE
Start date: February 22, 2013
Phase: Phase 4
Study type: Interventional

The study was done to: - test a strategy of using a resistance test to choose anti-HIV drugs - see how well combinations of new anti-HIV drugs work to lower HIV infection - see if taking new anti-HIV drugs together is safe and tolerable - see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study) - in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body - to see how people do after they stop having frequent clinic visits as part of a research study

NCT ID: NCT01598818 Completed - Vision Loss Clinical Trials

First-Sight Refractive Error Correction in the Developing World

Start date: May 11, 2012
Phase:
Study type: Observational

The aim of this study is to test the efficacy of the First-Sight refractive kit designed to provide refractive correction of simple hyperopia, myopia and astigmatism with autorefraction.

NCT ID: NCT01552512 Completed - Undernutrition Clinical Trials

Nutributter Programming to Prevent Undernutrition: an Evaluation

NPPU
Start date: June 2011
Phase: N/A
Study type: Interventional

This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.