Post Kala Azar Dermal Leishmaniasis

Miltefosine

International Centre for Diarrheal Disease Research, Bangladesh

Miltefosine for Children With PKDL

A Study for Safety and Efficacy of Miltefosine for Treatment of Children and Adolescents With Post-Kala-azar Dermal Leishmaniasis (PKDL) in Bangladesh and Association of Serum Vitamin E and Exposure to Arsenic With PKDL

Safety will be measured by the frequency of the adverse events.

Cure will be defined by the resolution of skin lesion by ≥ 90% and skin and blood specimens negative for leishmania donovani bodies and leishmania DNA at 12 months after treatment.

This will be measured by the association by PKDL and above mentioned genetic polymorphism. Here matched children who will be found during cross sectional survey for PKDL suspects will serve as controls.

This will be measured by investigating the association of each of these nutritional factors and arsenic with the development of PKDL where matched children without PKDL will serve as control.

International Centre for Diarrhoeal Disease Research, Bangladesh

Thrasher Research Fund

Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).

Arsenic Trioxide

Sex: Female, Male

Region of Enrollment

A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.

Dose of Arsenic That Blocks Activation of p53

Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy

Blood is drawn at 9 days to obtain a complete blood count

Complete Blood Count

Complete Blood Count (CBC)

Overall Study

Chul S. Ha, MD, Professor and Chair

Cancer Other Than Leukemia

IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).

The University of Texas Health Science Center at San Antonio

Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector

A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies as a Potential Chemotherapy Protector

Determine if the immunogenicity of oral typhoid can be enhanced in children by introducing zinc supplementation: Our recent studies on the interactions of oral cholera vaccine with breast milk and zinc provide some basis for improving immunogenicity, but additional work is needed to improve many of the oral vaccines. In this study we also plan to evaluate if the immune response to Cholera and Vivotif can be enhanced by supplementation with zinc using methods described earlier. We would like to study children, 2-5 years of age for this purpose.

There is a high burden of enteric parasites in the gut of people living in densely populated areas of less developed countries. The effect of concurrent parasitic infestations on immune responses has not been studied widely, although it is an area of utmost importance for natural protection as well as vaccine immuno-prophylaxis. In this study we plan to determine the impact of pretreatment with antiparasitic agents (albendazole and secnidazole) on the immunogenicity of the oral cholera and typhoid vaccines in children, 2-5 years of age

In this study, we aim to evaluate if immunogenicity of the oral cholera vaccine is modified in children living in a high arsenic contaminated area in Bangladesh. The plan is to study children 2-5 year old living in Shahrasti thana near Matlab where the tubewell water is highly contaminated with arsenic and this study will not be randomized double-blind, and compare their responses with responses of age matched children living in arsenic free area, such as in Mirpur area of Dhaka city. We only plan to study the effect of Dukoral vaccinees since this vaccine has been widely studied in Bangladesh. If an impact of arsenic is seen on immune response to this vaccine, future studies could be done with other vaccines including Vivotif.

Cholera

Typhoid

Placebo will be given according to randomization list

Placebo

Control will be selected from the Arsenic non contaminated Area

Control

Zinc Sulphate will be given according to randomization list

Zinc Sulphate

Albendazole and Secnidazole will be given according to randomization list

Albendazole and Secnidazole

Participant will be selected from the Arsenic Contaminated Area

Arsenic

Firdausi Qadri

Studies of Immune Responses to Orally Administered Vaccines in Developing Country

Studies of Acute and Memory Immune Responses to Orally Administered Vaccines in Developing Country Children and Factors That May Augment Such Responses

arsenic/diarrhea

Miltefosine for Children With PKDL

Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector

Studies of Immune Responses to Orally Administered Vaccines in Developing Country

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