Clinical trials: Leishmaniasis, Visceral
Post Kala Azar Dermal Leishmaniasis
Miltefosine for Children With PKDL
Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2.
- Trial name
- NCT02193022
- Testing
- Miltefosine
- Where
- Bangladesh
- Volunteers
- 80 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis
Clinical Prognostic Score to Predict Relapse in VL
This prospective cohort study has the aim to develop a prognostic tool to predict relapse in patients suffering from visceral leishmaniasis (VL) from VL endemic regions in Ethiopia.
- Trial name
- CPS (NCT05602610)
- Testing
- No intervention
- Where
- Ethiopia
- Volunteers
- 741 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Visceral Leishmaniasis
Combination Chemotherapy for the Treatment of Indian Kala-Azar
The investigators are using a sequential design to combine miltefosine and AmBisome in different doses.
- Trial name
- NCT00370825
- Testing
- Combination therapy with AmBisome and miltefosine
- Where
- India
- Volunteers
- 200 people
- Sponsor
- Banaras Hindu University
Hiv, Visceral Leishmaniasis
Recurrent Visceral Leishmaniasis in HIV Co-Infection
The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target…
- Trial name
- ALIVE (NCT07487350)
- Where
- Ethiopia
- Volunteers
- 20 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Visceral Leishmaniasis
Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis
The study is designed to determine the use of delivering point of care, rapid diagnosis with rK39 and treatment with AmBisome single dose of 10 mg/kg when administrated in the Primary Health Center (PHC) settings with regard to…
- Trial name
- NCT01566552
- Testing
- AMBISOME
- Where
- India
- Volunteers
- 1,300 people
- Sponsor
- Banaras Hindu University
Visceral Leishmaniasis, Human African Trypanosomiasis
Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases In Patients With Persistent Fever in Cambodia, Nepal, Democratic Republic of the Congo and Sudan (NIDIAG-Fever)
Tropical fevers have been a diagnostic challenge from the antiquity. Nowadays, despite the availability of good diagnostic capacities, undifferentiated febrile illnesses continue to be a thorny problem for travel physicians.
- Conditions
- Visceral Leishmaniasis, Human African Trypanosomiasis, Enteric Fever, Melioidosis
- Trial name
- NCT01766830
- Testing
- rk28 ICT, IT LEISH (rK39), Immunochromatographic HAT test
- Where
- 7 sites in Cambodia, Democratic Republic of the Congo and 2 more
- Volunteers
- 1,927 people
- Sponsor
- University Hospital, Geneva
Visceral Leishmaniasis
A Community Trial for Visceral Leishmaniasis (VL)
Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries in the world including Bangladesh. Where more than 90,000 VL cases have been reported since 1994. The disease is fatal if not treated.
- Trial name
- NCT01069198
- Testing
- Albendazole, Iron, Zinc and Vitamin A
- Where
- 2 sites in Bangladesh
- Volunteers
- 200 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
- Trial name
- NCT00486382
- Testing
- Leish-111f + MPL-SE Adjuvant
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Primary Visceral Leishmaniasis
A Phase II, Multicentre, Randomized, Two-arm Blinded Study to Assess the Efficacy and Safety of Two LXE408 Regimens for Treatment of Patients With Primary Visceral Leishmaniasis
This is a phase II, multicentre, randomized, two-arm blinded study with an open label calibrator arm in adults and adolescents (≥12 years) with confirmed primary VL.
- Trial name
- NCT05593666
- Testing
- LXE408, AmBisome®
- Where
- 2 sites in India
- Volunteers
- 101 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
The overall objective of this trial is to identify a safe and effective combination, (coadministration) short course treatment for the treatment of visceral leishmaniasis which could be easily deployed in a control programme and…
- Trial name
- NCT00696969
- Testing
- Amphotericin B Deoxycholate, Ambisome + Miltefosine, Ambisome and Paromomycin
- Where
- 2 sites in India
- Volunteers
- 634 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
- Trial name
- NCT00255567
- Testing
- Sodium Stibogluconate, Paromomycin sulphate, SSG and Paromomycin sulphate
- Where
- 5 sites in Ethiopia, Kenya and 2 more
- Volunteers
- 1,142 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Open-Label, Sequential Step, Safety and Efficacy Study to Determine the Optimal Single Dose of Ambisome for Patients With VL
This is a phase II/III open, comparative dose trial to find the lowest single dose of AmBisome for the treatment of primary, symptomatic visceral leishmaniasis(VL), in HIV negative patients.
- Trial name
- NCT00832208
- Testing
- Liposomal amphotericin B (Ambisome)
- Where
- 3 sites in Ethiopia, Sudan
- Volunteers
- 124 people
- Sponsor
- Drugs for Neglected Diseases
Leishmaniasis, Visceral
Combination Therapy in Indian Visceral Leishmaniasis
Rationale The overall objective of this trial is to identify a safe and effective combination, (co-administration) short course treatment for the treatment of VL which could be easily deployed in a control programme.
- Trial name
- NCT00523965
- Testing
- amphotericin B deoxycholate, Liposomal Amphotericin B with Miltefosine, Liposomal Amphotericin B and Paromomycin Sulfate
- Where
- India
- Volunteers
- 624 people
- Sponsor
- Banaras Hindu University
Visceral Leishmaniasis, Kala Azar
Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar
A cluster-randomized vector control trial in Bihar, India, and neighboring Nepal, will test the efficacy of long-lasting impregnated bednets (LLINs, Permanets) for reducing visceral leishmaniasis incidence.
- Trial name
- KALANET (NCT00318721)
- Testing
- Long Lasting Impregnated Nets (LLIN)
- Where
- 2 sites in India, Nepal
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Visceral Leishmaniasis, Immune Response
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.
- Conditions
- Visceral Leishmaniasis, Immune Response, Treatment
- Trial name
- VLNAC (NCT01138956)
- Testing
- N-acetylcysteine, Pentavalent antimonial
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Hospital Universitário Professor Edgard Santos
Post-kala-azar Dermal Leishmaniasis
A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis \& PKDL patients are genetically…
- Trial name
- NCT01975051
- Testing
- Mitefosine
- Where
- Bangladesh
- Volunteers
- 36 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
Miltefosine and liposomal amphotericin B (AmBisome) are approved drugs for visceral leishmaniasis. In this study both drugs will be given in a sequential manner.
- Trial name
- NCT00371995
- Testing
- Liposomal amphotericin B and Miltefosine
- Where
- 2 sites in India
- Volunteers
- 150 people
- Sponsor
- Banaras Hindu University
Leishmaniasis, Effects of Immunotherapy
SCH708980 With and Without AmBisome for Visceral Leishmaniasis
Background: Visceral leishmaniasis (VL) is an infection caused by parasites carried by sand flies. The parasites cause fever, weight loss, and enlargement of the spleen and liver. They can also affect the blood and immune system.
- Trial name
- NCT01437020
- Testing
- SCH708980 Anti-IL-10 monoclonal, AmBisome
- Where
- 2 sites in India
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cost-effective and Sustainable Vector Control Methods Will be Established to Reduce VL in India, Bangladesh and Nepal
Replacement of Insecticides to Control Visceral Leishmaniasis (VL)
Visceral leishmaniasis (VL) is a public health problem in Bangladesh, India and Nepal. To control the disease in these three countries a National kala-azar elimination program is ongoing.
- Trial name
- NCT01644682
- Testing
- IWFPL, IDWL, ITN
- Where
- Bangladesh
- Volunteers
- 3,600 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Visceral Leishmaniasis
Asymptomatic Leishmania Infection in HIV Patients
To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to inform the feasibility of a larger study…
- Trial name
- NCT02839603
- Where
- Ethiopia
- Volunteers
- 540 people
- Sponsor
- Institute of Tropical Medicine, Belgium