Clinical trials: Visceral Leishmaniasis
Visceral Leishmaniasis
Phase 1 LEISH-F3 + SLA-SE Vaccine Trial in Healthy Adult Volunteers
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of visceral leishmaniasis.
- Trial name
- NCT02071758
- Testing
- LEISH-F3 + SLA-SE, LEISH-F3 + GLA-SE
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
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
Visceral Leishmaniasis
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.
- Trial name
- NCT01122771
- Testing
- Liposomal amphotericin B, liposomal amphotericin B + miltefosine, liposomal amphotericin B + paromomycin
- Where
- 4 sites in Bangladesh
- Volunteers
- 602 people
- Sponsor
- Drugs for Neglected Diseases
Visceral Leishmaniasis
Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan
This study is designed to determine the efficacy of Fexinidazole as an oral treatment in Visceral Leishmanisasis sudanese adults patients.
- Trial name
- NCT01980199
- Testing
- Fexinidazole
- Where
- Sudan
- Volunteers
- 14 people
- Sponsor
- Drugs for Neglected Diseases
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)
Visceral Leishmaniasis
Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis
Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL.
- Trial name
- NCT00216346
- Testing
- Paromomycin sulfate, Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 667 people
- Sponsor
- PATH
Visceral Leishmaniasis
Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis
This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of…
- Trial name
- NCT00604955
- Testing
- Paromomycin sulfate
- Where
- 7 sites in India
- Volunteers
- 2,000 people
- Sponsor
- PATH
Visceral Leishmaniasis, Malnutrition
Visceral Leishmaniasis and Malnutrition in Amhara Regional State, Ethiopia
The project Visceral Leishmaniasis and Malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (VL).
- Trial name
- VL&MNEthio (NCT02148822)
- Volunteers
- 520 people
- Sponsor
- Instituto de Salud Carlos III
Visceral Leishmaniasis
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days after treatment begins), and at 6 months…
- Trial name
- NCT01328457
- Testing
- Paromomycin sulfate
- Where
- 3 sites in Bangladesh
- Volunteers
- 120 people
- Sponsor
- PATH
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
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
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, Visceral
To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar
The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian…
- Trial name
- NCT00876824
- Testing
- Amphotericin B Lipid emulsion, Liposomal Amphotericin B
- Where
- 4 sites in India
- Volunteers
- 500 people
- Sponsor
- Bharat Serums and Vaccines Limited
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
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
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, 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
Single Infusion of Liposomal Amphotericin B in Indian Visceral Leishmaniasis
The purpose of this trial is to evaluate the efficacy of single dose amphotericin B in the treatment of Visceral Leishmaniasis (VL) in India.
- Trial name
- NCT00628719
- Testing
- Liposomal Amphotericin B, amphotericin B deoxycholate
- Where
- India
- Volunteers
- 400 people
- Sponsor
- Banaras Hindu University
Visceral Leishmaniasis
Amphotericin B Treatment in Visceral Leishmaniasis
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses.
- Trial name
- NCT00310505
- Testing
- Amphotericin B deoxycholate given as daily administration
- Where
- India
- Volunteers
- 1,500 people
- Sponsor
- Banaras Hindu University
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