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Lymphatic Filariasis clinical trials

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NCT ID: NCT02032043 Completed - Onchocerciasis Clinical Trials

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)

Start date: February 2014
Phase:
Study type: Observational

Approximately 4,000 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Ivorian Ministry of Health). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections. 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations. 2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations. 3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

NCT ID: NCT01975441 Completed - Clinical trials for Lymphatic Filariasis

Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa

Start date: May 2014
Phase: Phase 2
Study type: Interventional

This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.

NCT ID: NCT01905436 Completed - Onchocerciasis Clinical Trials

Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia

DOLF-LIBERIA
Start date: March 2012
Phase:
Study type: Observational

Approximately 5,200 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis and onchocerciasis endemic areas. Subject selection will not be based on health status. Two sites will be studied, and each study will last for 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Investigators will compare annual and semiannual mass drug administration (MDA) for lymphatic filariasis and onchocerciasis, and investigators will compare the impact of these MDA schedules on soil transmitted helminth infections. MDA will be administered by others (Liberian Ministry of Health or Liberian Institute of Biomedical Research). The investigators will test the hypothesis that semiannual mass drug administration (MDA) is superior to annual MDA for elimination of lymphatic filariasis, onchocerciasis and for control of soil transmitted helminth (STH) infections. 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF) in these populations. 2. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of onchocerciasis in these populations. 3. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations. Continuation Activities (2019/2020): Additional one-time cross-sectional surveys will be completed in the Harper site in Maryland district in 2019 and in Lofa in 2020 to measure the long-term impact of MDA on W. bancrofti, O. volvulus, and on STH infection parameters following these cumulative 7-9 rounds of MDA since the baseline survey taken in 2013. Since the last DOLF surveys (3rd follow-ups) in these sites in 2016 & 2017, respectively, there have been a total of 3 annual rounds of MDA in both areas. These additional surveys will recruit 2,500 participants in the Maryland area villages and 3,200 in the Lofa area villages.

NCT ID: NCT01905423 Completed - Clinical trials for Lymphatic Filariasis

Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis

DOLF-Indo
Start date: May 2011
Phase:
Study type: Observational

Approximately 3,500 people will participate per year. The study population will include females and males over 5 years of age who live in filariasis endemic areas. The study will be performed in Indonesia in B. timori and W. bancrofti endemic areas over a period of 4 years. Participants will be studied only once in cross-sectional surveys. Some subjects may be included in more than one annual population survey, but this is not a longitudinal study. Purpose of the study is to evaluate different mass drug administration (MDA) regimens for lymphatic filariasis and also to study the impact of MDA on soil transmitted helminth infections (STH). MDA will administered by others (e.g., Ministry of Health). Results of this study may enhance efforts to control and eliminate these important neglected tropical diseases. The investigators will test the hypothesis that accelerated mass drug administration will be superior to annual MDA for elimination of lymphatic filariasis and for control of soil transmitted helminth infections (STH): 1. Compare the relative impact and cost effectiveness of annual vs. twice yearly mass drug administration (MDA) for elimination of lymphatic filariasis (LF). 2. Study the impact of annual vs. semiannual MDA on soil transmitted helminth (STH) infection in these populations.

NCT ID: NCT01629771 Completed - Clinical trials for Lymphatic Filariasis

Disability and Quality of Life in Patients With Lymphatic Filariasis in Rural Southern India

Start date: May 2012
Phase: N/A
Study type: Observational

According to the World Health Organization, lymphatic filariasis, a mosquito-borne parasitic disease, is the second leading cause of disability worldwide. Across 81 countries, approximately 120 million people are infected with the disease, and of those infected, an estimated 40% reside in India alone. The most disfiguring symptoms of lymphatic filariasis, elephantiasis and lymphedema, cause long-term suffering in patients who are then often embarrassed or even rejected from their communities. Because of the disease's debilitating physical and social effects on patients, this study will explore the intersection of disability and health-related quality of life (HRQoL) in lymphatic filariasis patients in India. Specifically, HRQoL and disability in lymphatic filariasis subjects and age- and gender- matched control subjects will be compared. Two HRQoL tools , the general Dermatology Life Quality Index (DLQI) and a disease-specific instrument developed by a dermatology group in India will be used to gauge HRQol. In addition, the demographic and disease-specific factors associated with HRQoL and disability in filarial lymphedema subjects will be identified.

NCT ID: NCT00511004 Completed - Clinical trials for Lymphatic Filariasis

Effect of Albendazole Dose on Treatment of Lymphatic Filariasis

Start date: July 2007
Phase: Phase 2
Study type: Interventional

This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment. Healthy people between 18 and 55 years of age who are in good health and who are infected with filarial worms may be eligible for this study. Participants undergo the following procedures: 3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India - Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years. - Urine pregnancy test for women of childbearing age . - Ultrasound test to look for filarial worms. - Treatment dose. - Monitoring for symptoms 6-month 3-day hospital stay - Medical history, physical examination and blood test. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Treatment dose for subjects receiving medicine every 6 months. - Urine pregnancy test for women of childbearing age. 1-year 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Urine pregnancy test for women of childbearing age. 18-month 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose for subjects receiving medicine every 6 months. - Urine pregnancy test for women of childbearing age. 24-month 3-day hospital stay - Medical history, physical examination and blood test. - Treatment dose. - Repeat ultrasound in subjects whose first ultrasound detected adult worms. - Urine pregnancy test for women of childbearing age.

NCT ID: NCT00406627 Completed - Clinical trials for Lymphatic Filariasis

Research for Elimination of Lymphatic Filariasis (ICIDR)

Start date: December 2006
Phase: N/A
Study type: Observational

The purpose of this study is to check blood samples for lymphatic filariasis to determine whether the recent Program to Eliminate Lymphatic Filariasis was successful in controlling lymphatic filariasis in areas of Egypt. Volunteers will participate in a health assessment program carried out by Ain Shams University and approved by the Egyptian Ministry of Health and Population. This program includes a brief interview and laboratory tests to detect worm parasites in participants' blood. Volunteers and family members found to have worms in their blood will be referred for treatment. This study will provide early detection of this parasitic infection and referral for prompt treatment in order to prevent spread of the infection to others. Approximately 23,500 people, 6 years of age and older, will participate per year. Study participants will include people living in areas of Egypt that are known to have the filariasis parasite. Volunteers will participate for up to 2 years.

NCT ID: NCT00375583 Completed - Clinical trials for Lymphatic Filariasis

Effect of Albendazole Dose on Clearance of Filarial Worms

Start date: September 9, 2006
Phase: Phase 2
Study type: Interventional

This study, conducted in Chennai, India, will determine whether a new treatment regimen of albendazole and diethylcarbamazine for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms, particulalry Wuchereria bancroti, that are spread by mosquitoes. The infection can lead to swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment. Healthy people between 18 and 55 years of age who are in good health and who are infected with Wuchereria bancrofti may be eligible for this 28-month study. Candidates must be willing to spend 4 days in the Government General Hospital in Chennai, India, at the beginning of the study. They are screened with a medical history, a brief physical examination, ultrasound (picture generated by sound waves) of the groin or chest, and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts. Participants undergo the following procedures: -4-day hospitalization Random assignment to receive either standard treatment (400 mg albendazole and 300 mg DEC given once a year for 2 years) or the experimental regimen (800 mg albendazole and 300 mg DEC given twice a year for 2 years) Urine pregnancy test for women of childbearing age Receive first treatment dose Monitoring for symptoms -6-month outpatient visit Short history, physical examination and blood test Second treatment dose for subjects receiving 800 mg albendazole Urine pregnancy test for women of childbearing age -1-year outpatient visit Short history, physical examination and blood test Second or third treatment dose, depending on treatment group Repeat ultrasound in subjects whose first ultrasound detected adult worm Urine pregnancy test for women of childbearing age -18-month outpatient visit Short history, physical examination and blood test Fourth treatment dose for subjects receiving 800 mg albendazole Urine pregnancy test for women of childbearing age -24-month outpatient visit Short history, physical examination and blood test Final dose of albendazole and DEC at standard doses Repeat ultrasound in subjects whose first ultrasound detected adult worms Urine pregnancy test for women of childbearing age

NCT ID: NCT00339417 Completed - Clinical trials for Lymphatic Filariasis

Effect of Albendazole Dose on Clearance of Filarial Worms

Start date: February 22, 2006
Phase: Phase 2
Study type: Interventional

This study, conducted in Mali, West Africa, will determine whether a new treatment regimen for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and genitalia and can progress to permanent swelling of the legs or arms called elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for 2 years. The study will see if the new regimen is more effective in lowering the numbers of Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the adult worms living in the lymph system. Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and are infected with Wuchereria bancrofti may be eligible for this study. Candidates are screened with a medical history, a brief physical examination and blood tests to check for infection with Wuchereria bancrofti and to measure white blood cell counts. Participants undergo the following procedures: -First visit Ultrasound examination to look for filarial worms in the body. Random assignment to receive either standard treatment or the experimental regimen Urine pregnancy test for women of child-bearing age. Receive first treatment dose. -6-month visit Short history, physical examination and blood test. Second treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -1-year visit Short history, physical examination and blood test. Second or third treatment dose, depending on treatment group. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age. -18-month visit Short history, physical examination and blood test. Fourth treatment dose for subjects in experimental treatment group. Urine pregnancy test for women of childbearing age. -24-month visit Short history, physical examination and blood test. Repeat ultrasound in subjects whose first ultrasound detected adult worms. Urine pregnancy test for women of childbearing age.

NCT ID: NCT00295698 Completed - HIV Infection Clinical Trials

Interaction Between HIV and Lymphatic Filariasis

Start date: August 2001
Phase: N/A
Study type: Interventional

The impact of lymphatic filariasis (LF) on HIV is assessed by measuring HIV viral load before and after DEC treatment of filariasis in double-infected individuals. The impact of HIV on lymphatic filariasis is assessed by measuring the success of DEC treatment on W. bancrofti antigenaemia and microfilaraemia in double-infected individuals. The effect of DEC treatment in individuals with lymphatic filariasis and/or HIV is assessed by measuring the pre- and post-treatment level of HIV viral load, immunological responses and micronutritional parameters, including antioxidants and markers of oxidative stress, in single- or double-infected individuals. The study is carried out as an anonymous, unlinked and double-blind placebo controlled study with cross-over design. The study groups comprise: 1) 18 double-infected individuals (HIV+/LF+), 2) 16 HIV infected individuals (HIV+/LF-) and 3) 25 individuals with lymphatic filariasis (HIV-/LF+). Based on stratified, blocked randomisation the study participants receive DEC treatment or placebo. Pre- and post-treatment (1 week, 12 weeks and 24 weeks post-treatment) blood samples are collected and analysed for HIV viral load, CD4+ T cell count, distinctive Th1 and Th2 cytokines, circulating filarial antigens (CFA), micronutrient status, antioxidant enzymes and markers of oxidative stress. After 12 weeks the study participants get the opposite treatment and post-treatment blood samples are collected four times with the same intervals as above.